Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma (STRASS)

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ClinicalTrials.gov Identifier: NCT01344018

Recruitment Status : Completed

First Posted : April 28, 2011

Results First Posted : April 24, 2023

Last Update Posted : April 24, 2023

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Sponsor:

Information provided by (Responsible Party):

European Organisation for Research and Treatment of Cancer - EORTC

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Sarcoma
Interventions	Procedure: therapeutic conventional surgery Radiation: 3-dimensional conformal radiation therapy
Enrollment	266

Participant Flow

Recruitment Details	A total of 266 (216 by EORTC members and 50 by non-EORTC members) patients were registered by 30 institutions between January 18, 2012 and April 10, 2017.
Pre-assignment Details


Arm/Group Title	Surgery Alone	Preoperative Radiotherapy Followed by En-bloc Surgery
Arm/Group Description	En-bloc resection of surrounding ti...	3D-CRT or IMRT to a dose of 50.4 Gy...
Arm/Group Description	En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated. therapeutic conventional surgery	3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions therapeutic conventional surgery 3-dimensional conformal radiation therapy
Period Title: Overall Study
Started	133	133
Completed	107	101
Not Completed	26	32
Reason Not Completed
Death	22	25
Lost to Follow-up	4	7

Baseline Characteristics

Arm/Group Title		Surgery Alone	Preoperative Radiotherapy Followed by En-bloc Surgery	Total
Arm/Group Description		En-bloc resection of surrounding ti...	3D-CRT or IMRT to a dose of 50.4 Gy...	Total of all reporting groups
Arm/Group Description		En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated. therapeutic conventional surgery	3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions therapeutic conventional surgery 3-dimensional conformal radiation therapy	Total of all reporting groups
Overall Number of Baseline Participants		133	133	266
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	133 participants	133 participants	266 participants
		61 (26 to 81)	61 (24 to 83)	61 (24 to 83)
Age, Customized Measure Type: Count of Participants Unit of measure: Participants
<= 50 years	Number Analyzed	133 participants	133 participants	266 participants
<= 50 years		29 21.8%	26 19.5%	55 20.7%
51 - 65 years	Number Analyzed	133 participants	133 participants	266 participants
51 - 65 years		58 43.6%	59 44.4%	117 44.0%
> 65 years	Number Analyzed	133 participants	133 participants	266 participants
> 65 years		46 34.6%	48 36.1%	94 35.3%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	133 participants	133 participants	266 participants
	Female	67 50.4%	71 53.4%	138 51.9%
	Male	66 49.6%	62 46.6%	128 48.1%
Race and Ethnicity Not Collected ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants
				0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	133 participants	133 participants	266 participants
United States		3	4	7
United Kingdom	Number Analyzed	133 participants	133 participants	266 participants
United Kingdom		16	10	26
Spain	Number Analyzed	133 participants	133 participants	266 participants
Spain		1	1	2
Canada	Number Analyzed	133 participants	133 participants	266 participants
Canada		13	15	28
Netherlands	Number Analyzed	133 participants	133 participants	266 participants
Netherlands		10	11	21
Sweden	Number Analyzed	133 participants	133 participants	266 participants
Sweden		1	1	2
Belgium	Number Analyzed	133 participants	133 participants	266 participants
Belgium		1	5	6
Norway	Number Analyzed	133 participants	133 participants	266 participants
Norway		6	7	13
Denmark	Number Analyzed	133 participants	133 participants	266 participants
Denmark		3	1	4
Poland	Number Analyzed	133 participants	133 participants	266 participants
Poland		6	5	11
Italy	Number Analyzed	133 participants	133 participants	266 participants
Italy		33	32	65
France	Number Analyzed	133 participants	133 participants	266 participants
France		38	41	79
Germany	Number Analyzed	133 participants	133 participants	266 participants
Germany		2	0	2
WHO performance status Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	133 participants	133 participants	266 participants
	PS 0: able to carry out all normal activity without restriction	100 75.2%	110 82.7%	210 78.9%
	PS 1: restricted in strenuous activity but ambulatory and able to carry out light work	33 24.8%	22 16.5%	55 20.7%
	PS 2: ambulatory and capable of all self-care but unable to carry out any work activities	0 0.0%	1 0.8%	1 0.4%
Concomitant non-malignant disease Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	133 participants	133 participants	266 participants
	No	70 52.6%	58 43.6%	128 48.1%
	Yes	63 47.4%	74 55.6%	137 51.5%
	Missing	0 0.0%	1 0.8%	1 0.4%

Outcome Measures

1.Primary Outcome


Title	Number of Patients With Abdominal Recurrence or Death
Description	Abdominal recurrence was defined by one of the following events: local...
Description	Abdominal recurrence was defined by one of the following events: local/abdominal or distant progressive disease during preoperative radiotherapy (as per RECIST 1.1), tumor or patient becoming inoperable (ASA score of 3 or involvement of superior mesenteric artery, aorta, or bone), peritoneal metastasis found at surgery, macroscopic residual disease left in at surgery (R2 resection), or local relapse (after macroscopically complete resection). Liver metastases were regarded as distant metastatic events. Patients with distant metastases were followed until local failure was detected. Patients without one of these events were censored at the date of last follow-up.
Time Frame	ARFS was measured from date of randomization to date of abdominal relapse or death, whichever occurred first, up to a maximum of 7 years.

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Surgery Alone	Preoperative Radiotherapy Followed by En-bloc Surgery
Arm/Group Description:	En-bloc resection of surrounding ti...	3D-CRT or IMRT to a dose of 50.4 Gy...
Arm/Group Description:	En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated. therapeutic conventional surgery	3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions therapeutic conventional surgery 3-dimensional conformal radiation therapy
Overall Number of Participants Analyzed	133	133
Measure Type: Count of Participants Unit of Measure: Participants
No event	72 54.1%	73 54.9%
Event	61 45.9%	60 45.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Surgery Alone, Preoperative Radiotherapy Followed by En-bloc Surgery
	Comments	Sample size was determined to provide 90% power for detecting a Hazard Ratio (HR)=0.52 (which corresponds to a 20% difference in ARFS rate at 5 years, from 50% in the surgery arm to 70% in the experimental arm) at a global 2-sided 5% significance level assuming ARFS followed an exponential distribution in both arms. This test required 102 events at the time of the statistical analysis.
	Type of Statistical Test	Superiority
	Comments	Time assessment biases were taken into account for the primary endpoint: Surgery alone arm: abdominal recurrence occurring prior to week 14 assessment was counted as occurring at week 14; progression occurring after the week 14 was counted as occurring at week 24. Preoperative RT arm: abdominal recurrence occurring was counted as occurring at week 14; and any abdominal recurrence occurring after and prior to or during the week 24 will be counted as occurring at week 24.

Statistical Test of Hypothesis	P-Value	0.955
	Comments	A 5% significance level was considered as a threshold for statistical significance.
	Method	Regression, Cox
	Comments	The time assessment biases correction described before was not applied to patients for whom death was the first event.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95% 0.71 to 1.44
	Estimation Comments	The arm having surgery alone was the reference arm.

2.Secondary Outcome


Title	Acute Toxicity Profile of Preoperative Radiotherapy.
Description	The acute toxicity was assessed in randomized patients who received at...
Description	The acute toxicity was assessed in randomized patients who received at least one dose of preoperative radiotherapy (RT). It follows Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 in the RT safety population, assuming the following classification: Grade 0 No event reported Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. For each item of the CTCAE, the worst grade of acute toxicity from the data of randomization prior to surgery was taken
Time Frame	From date of randomization to the date of surgical procedure, prior to surgery

Outcome Measure Data

Analysis Population Description

Only patients in the "Preoperative radiotherapy followed by en-bloc surgery" that received at least one dose of radiotherapy were considered for this secondary endpoint.


Arm/Group Title	Surgery Alone	Preoperative Radiotherapy Followed by En-bloc Surgery
Arm/Group Description:	En-bloc resection of surrounding ti...	3D-CRT or IMRT to a dose of 50.4 Gy...
Arm/Group Description:	En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated. therapeutic conventional surgery	3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions therapeutic conventional surgery 3-dimensional conformal radiation therapy
Overall Number of Participants Analyzed	0	127
Measure Type: Count of Participants Unit of Measure: Participants
CTCAE Grade 0		4 3.1%
CTCAE Grade 1-2		106 83.5%
CTCAE Grade 3		15 11.8%
CTCAE Grade 4		1 0.8%
CTCAE Grade 5		1 0.8%

3.Secondary Outcome


Title	Perioperative Complications
Description	Adverse events and side effects possibly related to surgery were asses...
Description	Adverse events and side effects possibly related to surgery were assessed according to the Dindo's classification. This scales the observed side effects as Grade 0 No event Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III Requiring surgical, endoscopic or radiological intervention Grade IV Life-threatening complication (including CNS complications) requiring IC/ICU-management Grade V Death of a patient For each item, the frequency of the worst grade of the observed toxicity was tabulated by treatment group. The perioperative period commence at the time of surgery (at the time of the induction anaesthesia) to the complete closure of the wound.
Time Frame	From the date of surgery, up to 60 days following surgery

Outcome Measure Data

Analysis Population Description

all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation followed by surgery)


Arm/Group Title	Surgery Alone	Preoperative Radiotherapy Followed by En-bloc Surgery
Arm/Group Description:	En-bloc resection of surrounding ti...	3D-CRT or IMRT to a dose of 50.4 Gy...
Arm/Group Description:	En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated. therapeutic conventional surgery	3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions therapeutic conventional surgery 3-dimensional conformal radiation therapy
Overall Number of Participants Analyzed	128	119
Measure Type: Count of Participants Unit of Measure: Participants
Dindo scale Grade 0	57 44.5%	34 28.6%
Dindo scale Grade 1-2	57 44.5%	58 48.7%
Dindo scale Grade 3	13 10.2%	24 20.2%
Dindo scale Grade 4	1 0.8%	2 1.7%
Dindo scale Grade 5	0 0.0%	1 0.8%

4.Secondary Outcome


Title	Late Complications
Description	The late toxicities occurring more than 60 days after surgery. These w...
Description	The late toxicities occurring more than 60 days after surgery. These were reported using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. This scales the observed toxicity from Grade 1 to 5, assuming the following classification: Grade 0 no event Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. Full AE reporting can be found in the Adverse Event Section.
Time Frame	From day 60 after surgery till end of follow-up, up to 7 years

Outcome Measure Data

Analysis Population Description

all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)


Arm/Group Title	Surgery Alone	Preoperative Radiotherapy Followed by En-bloc Surgery
Arm/Group Description:	En-bloc resection of surrounding ti...	3D-CRT or IMRT to a dose of 50.4 Gy...
Arm/Group Description:	En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated. therapeutic conventional surgery	3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions therapeutic conventional surgery 3-dimensional conformal radiation therapy
Overall Number of Participants Analyzed	128	127
Measure Type: Count of Participants Unit of Measure: Participants
CTCAE Grade 0	58 45.3%	53 41.7%
CTCAE Grade 1-2	51 39.8%	50 39.4%
CTCAE Grade 3	17 13.3%	20 15.7%
CTCAE Grade 4	2 1.6%	4 3.1%
CTCAE Grade 5	0 0.0%	0 0.0%

5.Secondary Outcome


Title	Tumor Response to Preoperative Radiotherapy
Description	For patients that received preoperative radiotherapy, the tumor respon...
Description	For patients that received preoperative radiotherapy, the tumor response was assessed using RECIST 1.1. Response criteria were essentially based on a set of measurable lesions identified at baseline as target lesions, and followed at the end of the radiotherapy. Response was not the primary endpoint, so a confirmatory CT-scan was not mandatory.
Time Frame	Two weeks after completion of Pre-operative Radiotherapy, before Surgery

Outcome Measure Data

Analysis Population Description

Tumor response using RECIST 1.1 was only assessed for patients receiving preoperative radiotherapy.


Arm/Group Title	Surgery Alone	Preoperative Radiotherapy Followed by En-bloc Surgery
Arm/Group Description:	En-bloc resection of surrounding ti...	3D-CRT or IMRT to a dose of 50.4 Gy...
Arm/Group Description:	En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated. therapeutic conventional surgery	3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions therapeutic conventional surgery 3-dimensional conformal radiation therapy
Overall Number of Participants Analyzed	0	133
Measure Type: Count of Participants Unit of Measure: Participants
Partial response		4 3.0%
Stable disease		99 74.4%
Progressive disease		18 13.5%
Early death		1 0.8%
Not evaluable		11 8.3%

6.Secondary Outcome


Title	Number of Patients With an Abdominal Recurrence
Description	Abdominal recurrence was defined in the ARFS section. The following ar...
Description	Abdominal recurrence was defined in the ARFS section. The following are considered competing events: death in the absence of abdominal failure distant metastases diagnosed before abdominal failure Patients without one of these events were censored at the date of last follow-up.
Time Frame	ARFI was measured from the date of randomization to the date of abdominal relapse, up to a maximum of 7 years

Outcome Measure Data

Analysis Population Description

Note that distant metastasis before or in the absence of abdominal recurrence was counted as a competing risk for this endpoint - whereas distant metastasis in the absence of abdominal recurrence was considered a non-event for the primary endpoint (ARFS). This explains the difference in non-events between the survival and interval endpoint.


Arm/Group Title	Surgery Alone	Preoperative Radiotherapy Followed by En-bloc Surgery
Arm/Group Description:	En-bloc resection of surrounding ti...	3D-CRT or IMRT to a dose of 50.4 Gy...
Arm/Group Description:	En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated. therapeutic conventional surgery	3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions therapeutic conventional surgery 3-dimensional conformal radiation therapy
Overall Number of Participants Analyzed	133	133
Measure Type: Count of Participants Unit of Measure: Participants
No event (censored)	61 45.9%	65 48.9%
Abdominal recurrence	46 34.6%	48 36.1%
Competing event (see outcome measure description)	26 19.5%	20 15.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Surgery Alone, Preoperative Radiotherapy Followed by En-bloc Surgery
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	ARFI was described using cumulative incidence curves. ARFI was compared between the two treatment arms using a Fine and Gray model.

Statistical Test of Hypothesis	P-Value	0.658
	Comments	A 5% significance level was considered as a threshold for statistical significance.
	Method	Fine and Gray model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 95% 0.74 to 1.60
	Estimation Comments	[Not Specified]

7.Secondary Outcome


Title	Number of Patients With Metastases or Death
Description	Alive and metastases free patients will be censored at the date of las...
Description	Alive and metastases free patients will be censored at the date of last follow-up.
Time Frame	Metastases free survival was measured from the date of randomization to the date of occurrence of distant metastases or death, whichever occurred first, up to a maximum of 7 years.

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Surgery Alone	Preoperative Radiotherapy Followed by En-bloc Surgery
Arm/Group Description:	En-bloc resection of surrounding ti...	3D-CRT or IMRT to a dose of 50.4 Gy...
Arm/Group Description:	En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated. therapeutic conventional surgery	3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions therapeutic conventional surgery 3-dimensional conformal radiation therapy
Overall Number of Participants Analyzed	133	133
Measure Type: Count of Participants Unit of Measure: Participants
Alive and metastases free (censored)	88 66.2%	92 69.2%
metastasis and/or death (event)	45 33.8%	41 30.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Surgery Alone, Preoperative Radiotherapy Followed by En-bloc Surgery
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.595
	Comments	A 5% significance level was considered as a threshold for statistical significance.
	Method	Regression, Cox
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95% 0.58 to 1.36
	Estimation Comments	[Not Specified]

8.Secondary Outcome


Title	Number of Patients Alive
Description	Alive patients were censored at the date of last follow-up. Causes of ...
Description	Alive patients were censored at the date of last follow-up. Causes of death were recorded and reported as a table.
Time Frame	Overall survival was measured from the date of randomization to the date of death, whatever the cause, up to a maximum of 7 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Surgery Alone	Preoperative Radiotherapy Followed by En-bloc Surgery
Arm/Group Description:	En-bloc resection of surrounding ti...	3D-CRT or IMRT to a dose of 50.4 Gy...
Arm/Group Description:	En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated. therapeutic conventional surgery	3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions therapeutic conventional surgery 3-dimensional conformal radiation therapy
Overall Number of Participants Analyzed	133	133
Measure Type: Count of Participants Unit of Measure: Participants
Alive (censored)	111 83.5%	108 81.2%
Death (event)	22 16.5%	25 18.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Surgery Alone, Preoperative Radiotherapy Followed by En-bloc Surgery
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.615
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.16
	Confidence Interval	(2-Sided) 95% 0.65 to 2.05
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Adverse Event Reporting Description	Patient population: all cause mortality: all patients serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)

Arm/Group Title	Surgery Alone		Preoperative Radiotherapy Followed by En-bloc Surgery
Arm/Group Description	En-bloc resection of surrounding ti...		3D-CRT or IMRT to a dose of 50.4 Gy...
Arm/Group Description	En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated. therapeutic conventional surgery		3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions therapeutic conventional surgery 3-dimensional conformal radiation therapy
All-Cause Mortality
	Surgery Alone		Preoperative Radiotherapy Followed by En-bloc Surgery
	Affected / at Risk (%)		Affected / at Risk (%)
Total	22/133 (16.54%)		25/133 (18.80%)
Serious Adverse Events Serious Adverse Events
	Surgery Alone		Preoperative Radiotherapy Followed by En-bloc Surgery
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	37/128 (28.91%)		48/127 (37.80%)
Blood and lymphatic system disorders
ANAEMIA ^* 1	1/128 (0.78%)	1	3/127 (2.36%)	3
Cardiac disorders
ARRHYTHMIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
CARDIAC ARREST ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	2
TACHYCARDIA ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
Gastrointestinal disorders
ABDOMINAL ADHESIONS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
ABDOMINAL HERNIA ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
ABDOMINAL PAIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	2
ASCITES ^* 1	0/128 (0.00%)	0	3/127 (2.36%)	3
CONSTIPATION ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	2
CROHN'S DISEASE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
DIAPHRAGMATIC HERNIA, OBSTRUCTIVE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
DIARRHOEA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
DUODENAL OBSTRUCTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	3
ENTEROCUTANEOUS FISTULA ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	2
GASTRIC FISTULA ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
GASTROINTESTINAL HAEMORRHAGE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GASTROINTESTINAL HYPOMOTILITY ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GASTROINTESTINAL MOTILITY DISORDER ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GASTROPLEURAL FISTULA ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
HAEMATEMESIS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
ILEUS ^* 1	0/128 (0.00%)	0	3/127 (2.36%)	3
IMPAIRED GASTRIC EMPTYING ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	2
INTESTINAL OBSTRUCTION ^* 1	1/128 (0.78%)	1	2/127 (1.57%)	2
INTRA-ABDOMINAL FLUID COLLECTION ^* 1	5/128 (3.91%)	6	5/127 (3.94%)	6
JEJUNAL STENOSIS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
NAUSEA ^* 1	0/128 (0.00%)	0	3/127 (2.36%)	3
PANCREATIC FISTULA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
PANCREATITIS NECROTISING ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
RETROPERITONEAL HAEMORRHAGE ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
SMALL INTESTINAL OBSTRUCTION ^* 1	0/128 (0.00%)	0	3/127 (2.36%)	5
SUBILEUS ^* 1	5/128 (3.91%)	5	2/127 (1.57%)	2
UPPER GASTROINTESTINAL HAEMORRHAGE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
VOMITING ^* 1	0/128 (0.00%)	0	3/127 (2.36%)	3
General disorders
ASTHENIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
ULCER ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
Hepatobiliary disorders
CHOLECYSTITIS ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
Infections and infestations
ABDOMINAL INFECTION ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
ABSCESS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
BACTERAEMIA ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
BACTERIAL INFECTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
DEVICE OCCLUSION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
EMPYEMA ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
GENITAL HERPES ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
HERPES ZOSTER ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INTERVERTEBRAL DISCITIS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
PANCREATIC ABSCESS ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
PERITONITIS ^* 1	2/128 (1.56%)	2	2/127 (1.57%)	2
POST PROCEDURAL INFECTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
RETROPERITONEAL ABSCESS ^* 1	3/128 (2.34%)	3	1/127 (0.79%)	1
RETROPERITONEAL INFECTION ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
SEPSIS ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	2
SEPTIC SHOCK ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
SKIN INFECTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
URINARY TRACT INFECTION ^* 1	0/128 (0.00%)	0	3/127 (2.36%)	3
WOUND INFECTION ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	2
Injury, poisoning and procedural complications
ANASTOMOTIC HAEMORRHAGE ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
ANASTOMOTIC LEAK ^* 1	0/128 (0.00%)	0	3/127 (2.36%)	3
GASTROINTESTINAL ANASTOMOTIC LEAK ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
INCISIONAL HERNIA, OBSTRUCTIVE ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
PANCREATIC LEAK ^* 1	2/128 (1.56%)	3	0/127 (0.00%)	0
PERIPANCREATIC FLUID COLLECTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
POST PROCEDURAL COMPLICATION ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	2
POST PROCEDURAL HAEMORRHAGE ^* 1	2/128 (1.56%)	2	0/127 (0.00%)	0
POSTOPERATIVE ILEUS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
SPINAL FRACTURE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
WOUND DEHISCENCE ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
Investigations
BLOOD CREATININE INCREASED ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
Metabolism and nutrition disorders
DECREASED APPETITE ^* 1	0/128 (0.00%)	0	3/127 (2.36%)	3
DEHYDRATION ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	2
DIABETIC KETOACIDOSIS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
HYPERGLYCAEMIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
HYPERKALAEMIA ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
HYPOALBUMINAEMIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
HYPOKALAEMIA ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	2
MALNUTRITION ^* 1	1/128 (0.78%)	1	4/127 (3.15%)	4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
Nervous system disorders
ISCHAEMIC CEREBRAL INFARCTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
SPINAL CORD INFARCTION ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
Renal and urinary disorders
ACUTE KIDNEY INJURY ^* 1	1/128 (0.78%)	1	3/127 (2.36%)	3
HAEMATURIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
HYDRONEPHROSIS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
RENAL FAILURE ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
Reproductive system and breast disorders
PELVIC FLUID COLLECTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
PULMONARY EMBOLISM ^* 1	1/128 (0.78%)	1	4/127 (3.15%)	4
RESPIRATORY DISTRESS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
RESPIRATORY FAILURE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
Skin and subcutaneous tissue disorders
TOXIC SKIN ERUPTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
Surgical and medical procedures
LARGE INTESTINE ANASTOMOSIS ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
Vascular disorders
DEEP VEIN THROMBOSIS ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	3
HAEMATOMA ^* 1	2/128 (1.56%)	2	0/127 (0.00%)	0
HAEMORRHAGE ^* 1	2/128 (1.56%)	2	1/127 (0.79%)	1
HYPOVOLAEMIC SHOCK ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
ISCHAEMIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
LYMPHOCELE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
LYMPHORRHOEA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
NECROSIS ISCHAEMIC ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
PERIPHERAL ISCHAEMIA ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
1 Term from vocabulary, CTCAE_v4 * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Surgery Alone		Preoperative Radiotherapy Followed by En-bloc Surgery
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	124/128 (96.88%)		127/127 (100.00%)
Blood and lymphatic system disorders
ANEMIA ^* 1	0/128 (0.00%)	0	4/127 (3.15%)	5
Cardiac disorders
ATRIAL FIBRILLATION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
CAR OTH ARRHYTHMIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
CAR OTH TACHYCARDIA, PT ON CHEMOTHERAPY, NOT RELATED TO PRIMARY DISEASE TX ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
CARDIAC ARREST ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	3
MYOCARDIAL INFARCTION ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
SINUS BRADYCARDIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
SINUS TACHYCARDIA ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
Ear and labyrinth disorders
EAR PAIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
HEARING IMPAIRED ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	3
VERTIGO ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
Endocrine disorders
ADRENAL INSUFFICIENCY ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
END OTH PRECOCIOUS POSTMENOPAUSALITY ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
END OTH THYMIC HYPERPLASIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
HYPERTHYROIDISM ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
HYPOTHYROIDISM ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
Eye disorders
BLURRED VISION ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
EYE OTH AMAUROSIS FUGAX ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
EYE OTH CONJUNCTIVAL PALLOR ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
EYE OTH DIFFICULTY TO OPEN THE LEFT EYELID ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
Gastrointestinal disorders
ABDOMINAL DISTENSION ^* 1	1/128 (0.78%)	1	1/127 (0.79%)	1
ABDOMINAL PAIN ^* 1	19/128 (14.84%)	36	36/127 (28.35%)	74
ANAL HEMORRHAGE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
ASCITES ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
BLOATING ^* 1	0/128 (0.00%)	0	3/127 (2.36%)	5
BURN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
COLONIC FISTULA ^* 1	2/128 (1.56%)	2	1/127 (0.79%)	1
COLONIC PERFORATION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
CONSTIPATION ^* 1	11/128 (8.59%)	19	40/127 (31.50%)	83
DIARRHEA ^* 1	17/128 (13.28%)	29	59/127 (46.46%)	143
DUODENAL OBSTRUCTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
DUODENAL ULCER ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	2
DYSPEPSIA ^* 1	0/128 (0.00%)	0	8/127 (6.30%)	10
FECAL INCONTINENCE ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
FLATULENCE ^* 1	2/128 (1.56%)	2	4/127 (3.15%)	4
GAS OTH ABDOMINAL CRAMPS ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	3
GAS OTH ABDOMINAL METEORISM ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	2
GAS OTH ABSCESS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH ACCELERATION OF TRANSIT ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH BELCHING ^* 1	1/128 (0.78%)	2	0/127 (0.00%)	0
GAS OTH BOWEL OBSTRUCTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH COLON HERNIA ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
GAS OTH DENTAL PAIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH DIGESIVE TROUBLE (IMPERIOSITY) ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH DIGESTIVE INTOLERANCE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH DIGESTIVE TRANSIT ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
GAS OTH DIGESTIVE TROUBLE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH DIVERTICULITIS (MILD SYMPTOMS BUT NOT VISIBLE ON SCAN) ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
GAS OTH ENTERO-CUTANEOUS FISTULA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	2
GAS OTH ENTEROCUTANEOUS FISTULA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH EPIGASTRIC PAIN ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	2
GAS OTH EXCACERBATION CROHN'S DISEASE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH FISTULOUS ORIFICE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH GASTRIC DISORDERS ^* 1	0/128 (0.00%)	0	3/127 (2.36%)	3
GAS OTH GASTRIC PAIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	3
GAS OTH GASTROINTESTINAL DISORDERS (INTOLERANACE) ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH HEMATEMESIS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH ILEAL ADHESIONS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH INCREASED URGENCY OF DEFECATION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH INFECTED RETROPERITONEAL FLUID COLLECTION ^* 1	1/128 (0.78%)	2	0/127 (0.00%)	0
GAS OTH INTESTINAL HYPOMOTILITY ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	2
GAS OTH IVER COLIC ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH LEFT RETROPERITONEAL COLLECTION, POSSIBLE PANCREATIC LEAK ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
GAS OTH LOWER ABDOMINAL HEAVINESS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH MALNUTRIRION ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
GAS OTH OBSTIPATION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH PAIN AT RIGHT HYPOCHONDRE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH PAIN AT RIGHT HYPOCONDRE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH POSTPRANDIAL PAIN ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
GAS OTH RETROPERITONEAL ABSCESS ^* 1	1/128 (0.78%)	2	1/127 (0.79%)	1
GAS OTH SENSITIVE ABDOMEN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH SUB-OCCLUSION ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
GAS OTH SUB-OCCLUSIVE SYNDROME ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
GAS OTH SUBOCLUSIVE SYNDROME ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
GAS OTH SWELLING LEFT LOWER ABDOMEN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH TRANSIT DISORDERS ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	3
GAS OTH TRANSIT TROUBLES ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GAS OTH VAGUE ABDOMINAL COMPLAINTS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GASTRIC HEMORRHAGE ^* 1	1/128 (0.78%)	1	1/127 (0.79%)	1
GASTRIC ULCER ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GASTRITIS ^* 1	2/128 (1.56%)	4	0/127 (0.00%)	0
GASTROESOPHAGEAL REFLUX DISEASE ^* 1	1/128 (0.78%)	1	7/127 (5.51%)	15
GASTROINTESTINAL PAIN ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	4
GASTROPARESIS ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	3
ILEAL STENOSIS ^* 1	1/128 (0.78%)	1	1/127 (0.79%)	1
ILEUS ^* 1	0/128 (0.00%)	0	3/127 (2.36%)	4
JEJUNAL STENOSIS ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	5
NAUSEA ^* 1	10/128 (7.81%)	15	92/127 (72.44%)	333
PANCREATIC FISTULA ^* 1	1/128 (0.78%)	2	0/127 (0.00%)	0
RECTAL FISTULA ^* 1	0/128 (0.00%)	0	3/127 (2.36%)	3
RECTAL HEMORRHAGE ^* 1	1/128 (0.78%)	2	0/127 (0.00%)	0
SMALL INTESTINAL OBSTRUCTION ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	2
SMALL INTESTINAL STENOSIS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
STOMACH PAIN ^* 1	2/128 (1.56%)	3	2/127 (1.57%)	2
UPPER GASTROINTESTINAL HEMORRHAGE ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	2
VOMITING ^* 1	2/128 (1.56%)	2	29/127 (22.83%)	64
General disorders
CHILLS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	2
EDEMA FACE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
EDEMA LIMBS ^* 1	5/128 (3.91%)	9	12/127 (9.45%)	50
EDEMA TRUNK ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	6
FATIGUE ^* 1	25/128 (19.53%)	41	91/127 (71.65%)	394
FEVER ^* 1	2/128 (1.56%)	2	6/127 (4.72%)	7
FLU LIKE SYMPTOMS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GEN OTH ALTERATION OF THE GENERAL STATE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	2
GEN OTH DISCRETE ACCELERATION OF TRANSIT ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GEN OTH GENERAL STATUS IMPAIRMENT ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GEN OTH NIGHT SWEATS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GEN OTH RADIATION PAIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	3
GEN OTH RIGHT SUB PUBIC PAIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GEN OTH RIGHT SUS PUBIC PAIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GEN OTH TRANSIT DISORDERS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
GEN OTH WORSENING IN GENERAL CONDITION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
LOCALIZED EDEMA ^* 1	1/128 (0.78%)	1	1/127 (0.79%)	1
NECK PAIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
NON-CARDIAC CHEST PAIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	5
PAIN ^* 1	12/128 (9.38%)	15	16/127 (12.60%)	50
Immune system disorders
ALLERGIC REACTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
Infections and infestations
ABDOMINAL INFECTION ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
BONE INFECTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	3
BRONCHIAL INFECTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
CATHETER RELATED INFECTION ^* 1	2/128 (1.56%)	2	2/127 (1.57%)	2
INF OTH BLOOD INFECTION WITH STAPHYLOCOCCUS EPIDERMIS ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
INF OTH CHEST INFECTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	4
INF OTH CLOSTRIDIUM DIFFICILE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INF OTH FUNGEMIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INF OTH HELICOBACTER PYLORI INFECTION ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
INF OTH HERPES GENITALIS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INF OTH HERPES ZOSTER ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INF OTH HERPES ZOSTER IN RIGHT LUMBAR REGION ALMOST RESOLVED. ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INF OTH HERPES ZOSTER IN RIGHT LUMBAR REGION. ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INF OTH HSV-1 IN GENITAL AREA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INF OTH INFECTED ABDOMINAL COLLECTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INF OTH INFECTED POST-OPERATIVE COLLECTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INF OTH SURGICAL BED INFECTIOUS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INF OTH UNSPECIFIC INFECTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INF OTH ZONA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
PAPULOPUSTULAR RASH ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	2
SEPSIS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
SINUSITIS ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
SKIN INFECTION ^* 1	1/128 (0.78%)	1	2/127 (1.57%)	4
UPPER RESPIRATORY INFECTION ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
URINARY TRACT INFECTION ^* 1	5/128 (3.91%)	5	6/127 (4.72%)	7
WOUND INFECTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
Injury, poisoning and procedural complications
BURN ^* 1	1/128 (0.78%)	1	1/127 (0.79%)	1
DERMATITIS RADIATION ^* 1	1/128 (0.78%)	1	30/127 (23.62%)	63
FALL ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INJ OTH DIAFRAGMATIC HERNIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INJ OTH EVENTRATION ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	3
INJ OTH EVENTRATION SURGERY ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INJ OTH INCISIONAL HERNIA ^* 1	4/128 (3.13%)	11	1/127 (0.79%)	1
INJ OTH INTESTINAL ADHESIONS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INJ OTH LEFT INGUINAL HERNIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INJ OTH RETROPERITONEAL FLUID COLLECTION (NEGATIVE FOR INFECTION) ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	2
INJ OTH RIGHT INGUINAL HERNIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INJ OTH SMALL RETROPERITONEAL COLLECTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INJ OTH SURGERY WOUND SENSITIVE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INJ OTH WOUND PAIN (INTERMITTENT) ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
INJ OTH WOUND SURGERY PAINFUL ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
SPINAL FRACTURE ^* 1	0/128 (0.00%)	0	3/127 (2.36%)	5
WOUND COMPLICATION ^* 1	3/128 (2.34%)	5	2/127 (1.57%)	4
WOUND DEHISCENCE ^* 1	5/128 (3.91%)	10	5/127 (3.94%)	10
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
CPK INCREASED ^* 1	1/128 (0.78%)	1	1/127 (0.79%)	1
CREATININE INCREASED ^* 1	1/128 (0.78%)	2	0/127 (0.00%)	0
INR INCREASED ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
INV OTH DECREASED IRON ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INV OTH INFLAMMATORY SYNDROME ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
INV OTH LDH INCREASED ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
INV OTH URINE OUTPUT INCREASED ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
WEIGHT GAIN ^* 1	5/128 (3.91%)	20	4/127 (3.15%)	7
WEIGHT LOSS ^* 1	23/128 (17.97%)	41	63/127 (49.61%)	160
Metabolism and nutrition disorders
ACIDOSIS ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	2
ANOREXIA ^* 1	11/128 (8.59%)	14	61/127 (48.03%)	160
DEHYDRATION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	4
HYPERGLYCEMIA ^* 1	2/128 (1.56%)	2	1/127 (0.79%)	1
HYPERKALEMIA ^* 1	1/128 (0.78%)	5	5/127 (3.94%)	6
HYPERMAGNESEMIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
HYPERURICEMIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
HYPOALBUMINEMIA ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
HYPOCALCEMIA ^* 1	1/128 (0.78%)	1	2/127 (1.57%)	2
HYPOKALEMIA ^* 1	1/128 (0.78%)	1	3/127 (2.36%)	6
HYPOMAGNESEMIA ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	3
HYPONATREMIA ^* 1	2/128 (1.56%)	7	1/127 (0.79%)	1
HYPOPHOSPHATEMIA ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	2
MET OTH MALNUTRITION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
Musculoskeletal and connective tissue disorders
ARTHRITIS ^* 1	3/128 (2.34%)	5	1/127 (0.79%)	1
BACK PAIN ^* 1	4/128 (3.13%)	5	18/127 (14.17%)	30
BONE PAIN ^* 1	2/128 (1.56%)	2	0/127 (0.00%)	0
FLANK PAIN ^* 1	3/128 (2.34%)	4	12/127 (9.45%)	25
MUS OTH ARTICULAR PAIN AT LEFT SHOULDER ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
MUS OTH DORSAL ARTHROSIS ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
MUS OTH INGUINAL HERNIA ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
MUS OTH INGUINLA HERNIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
MUS OTH LEFT ILIAC FOSSA ABSCESS ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
MUS OTH LEFT LIMB MUSUCLAR DEFICIT ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
MUS OTH LEFT SHOULDER PAIN ^* 1	1/128 (0.78%)	2	0/127 (0.00%)	0
MUS OTH LUMBAR FOSSA MUSCULAR CRAMPS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
MUS OTH MASTICATION PROBLEM ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
MUS OTH MUSCLE CRAMPS LEGS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
MUS OTH MUSCULAR CRAMPS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
MUS OTH PAIN (LUMBAR REGION) ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
MUS OTH PAIN AND MUSCLE CRAMPS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
MUS OTH PAIN AND MUSCLES CRAMPS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
MUS OTH PAIN AT THE LEFT LEG ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	2
MUS OTH PAIN AT THE LEFT LUMBAR FOSSA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
MUS OTH PAIN AT THIGH ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
MUS OTH PARAVERTEBRAL PAIN ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
MUS OTH RIGHT INGUINAL HERNIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	4
MUS OTH RIGHT LUMBAR FOSSA PAIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
MUS OTH RIGHT PARAVERTEBRAL PAIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
MUS OTH RIGHT SHOULDER AND RIGHT SIRLOIN PAIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
MUS OTH SHOULDER PAIN ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
MUS OTH SHOULDER PAIN (LEFT) ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
MUS OTH SURGERY WOUND SENSATIVE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	2
MUS OTH TENDON RUPTURE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
MUS OTH TRUNK PAIN ^* 1	1/128 (0.78%)	2	0/127 (0.00%)	0
MUSCLE WEAKNESS LOWER LIMB ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
MUSCLE WEAKNESS TRUNK ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
MYALGIA ^* 1	5/128 (3.91%)	5	2/127 (1.57%)	3
NECK PAIN ^* 1	1/128 (0.78%)	1	2/127 (1.57%)	2
PAIN IN EXTREMITY ^* 1	4/128 (3.13%)	6	5/127 (3.94%)	7
SCOLIOSIS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEO OTH GASTRIC POLYP ^* 1	1/128 (0.78%)	2	0/127 (0.00%)	0
TUMOR PAIN ^* 1	1/128 (0.78%)	1	5/127 (3.94%)	9
Nervous system disorders
DIZZINESS ^* 1	1/128 (0.78%)	1	3/127 (2.36%)	3
DYSESTHESIA ^* 1	3/128 (2.34%)	4	4/127 (3.15%)	7
DYSGEUSIA ^* 1	0/128 (0.00%)	0	6/127 (4.72%)	8
HEADACHE ^* 1	5/128 (3.91%)	7	14/127 (11.02%)	26
ISCHEMIA CEREBROVASCULAR ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
LETHARGY ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
NER OTH CRURALGIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
NER OTH DEAFFERENTATION PAIN ^* 1	1/128 (0.78%)	2	0/127 (0.00%)	0
NER OTH HYPERSENSITIVITY OF THE EXTERNAL FACE OF THE RIGHT THIGH ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	2
NER OTH INSENSIBILITY PART RIGHT HIP ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
NER OTH ISCHEMIC INFARCTION BRAIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
NER OTH L5 DISTAL DEFICIT ^* 1	1/128 (0.78%)	2	0/127 (0.00%)	0
NER OTH LEFT GROIN/THIGH NUMBNESS ^* 1	1/128 (0.78%)	2	0/127 (0.00%)	0
NER OTH LEG NUMBNESS (LEFT) ^* 1	1/128 (0.78%)	2	0/127 (0.00%)	0
NER OTH LEG NUMBNESS (LEG) ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
NER OTH NEUROGENIC PAIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
NER OTH NEUROPATHIC PAIN ^* 1	1/128 (0.78%)	6	0/127 (0.00%)	0
NER OTH NUMBNESS (LEFT THIGH) ^* 1	1/128 (0.78%)	2	0/127 (0.00%)	0
NER OTH NUMBNESS LEFT LEG ^* 1	1/128 (0.78%)	2	0/127 (0.00%)	0
NER OTH NUMBNESS LEFT THIGH ^* 1	1/128 (0.78%)	3	0/127 (0.00%)	0
NER OTH NUMBNESS RIGHT LEG ^* 1	1/128 (0.78%)	2	0/127 (0.00%)	0
NER OTH PARAPLEGIA ^* 1	1/128 (0.78%)	7	0/127 (0.00%)	0
NER OTH RIGHT BIG TOE HYPOESTHESIA ^* 1	1/128 (0.78%)	2	0/127 (0.00%)	0
NER OTH RIGHT SCIATICA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	2
NER OTH SENSITIVITY TO THE LOWER PART OF THE STERNUM ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
NER OTH SENSORY DEFICIT AT THE ANTERIOR FACE OF THE LEFT THIGH ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
NER OTH SEQUELAE AFTER ISCHEMIC INFARCTION BRAIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	2
NER OTH SPONGY FEELING LEFT FOSSA ILIACA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
NEURALGIA ^* 1	0/128 (0.00%)	0	3/127 (2.36%)	3
PARESTHESIA ^* 1	6/128 (4.69%)	16	5/127 (3.94%)	5
PERIPHERAL MOTOR NEUROPATHY ^* 1	6/128 (4.69%)	13	3/127 (2.36%)	6
PERIPHERAL SENSORY NEUROPATHY ^* 1	14/128 (10.94%)	30	15/127 (11.81%)	24
STROKE ^* 1	2/128 (1.56%)	2	1/127 (0.79%)	1
TREMOR ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
VASOVAGAL REACTION ^* 1	1/128 (0.78%)	1	1/127 (0.79%)	1
Psychiatric disorders
AGITATION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
ANXIETY ^* 1	1/128 (0.78%)	1	4/127 (3.15%)	7
CONFUSION ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
DELIRIUM ^* 1	0/128 (0.00%)	0	3/127 (2.36%)	4
DEPRESSION ^* 1	1/128 (0.78%)	1	4/127 (3.15%)	6
INSOMNIA ^* 1	0/128 (0.00%)	0	3/127 (2.36%)	6
PSY OTH SLEEP DISORDERS ^* 1	1/128 (0.78%)	1	1/127 (0.79%)	2
PSY OTH SOCIAL PHOBIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
Renal and urinary disorders
ACUTE KIDNEY INJURY ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	2
ADRENAL INSUFFICIENCY ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
BLADDER SPASM ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
CHRONIC KIDNEY DISEASE ^* 1	3/128 (2.34%)	4	0/127 (0.00%)	0
HEMATURIA ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	2
REN OTH ACUTE RENAL FAILURE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
REN OTH BASELINE URINARY SYMPTOMS, OTHER. ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
REN OTH BLADDER LITHIASIS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
REN OTH BLOCKED URINARY CATHETER ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
REN OTH DYSURIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
REN OTH HYDRONEPHROSIS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
REN OTH INGUINAL HERNIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
REN OTH POLLAKIURIA ^* 1	1/128 (0.78%)	1	1/127 (0.79%)	1
REN OTH RENAL FAILURE ^* 1	2/128 (1.56%)	2	0/127 (0.00%)	0
REN OTH RENAL INSUFFICIENCY ^* 1	1/128 (0.78%)	2	2/127 (1.57%)	2
REN OTH SYNDROME OF JUNCTION OF THE LEFT KIDNEY ^* 1	1/128 (0.78%)	2	0/127 (0.00%)	0
REN OTH URINARY DISORDERS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
RENAL COLIC ^* 1	1/128 (0.78%)	1	1/127 (0.79%)	1
URINARY FREQUENCY ^* 1	1/128 (0.78%)	1	5/127 (3.94%)	9
URINARY INCONTINENCE ^* 1	1/128 (0.78%)	1	1/127 (0.79%)	1
URINARY RETENTION ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
URINARY TRACT OBSTRUCTION ^* 1	3/128 (2.34%)	3	1/127 (0.79%)	1
URINARY URGENCY ^* 1	1/128 (0.78%)	1	1/127 (0.79%)	2
Reproductive system and breast disorders
EJACULATION DISORDER ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
ERECTILE DYSFUNCTION ^* 1	2/128 (1.56%)	8	0/127 (0.00%)	0
GENITAL EDEMA ^* 1	3/128 (2.34%)	7	1/127 (0.79%)	1
GYNECOMASTIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
PELVIC PAIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
PREMATURE MENOPAUSE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
REP OTH HYDROCELE ^* 1	1/128 (0.78%)	1	1/127 (0.79%)	1
REP OTH RIGHT SIDE VARICOCELE ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
REP OTH TESTICULAR OEDEMA (LEFT) ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
SCROTAL PAIN ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
TESTICULAR PAIN ^* 1	2/128 (1.56%)	3	0/127 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
ASPIRATION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
ATELECTASIS ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	2
BRONCHIAL OBSTRUCTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
COUGH ^* 1	3/128 (2.34%)	3	5/127 (3.94%)	7
DYSPNEA ^* 1	4/128 (3.13%)	4	9/127 (7.09%)	13
HICCUPS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
HOARSENESS ^* 1	1/128 (0.78%)	2	0/127 (0.00%)	0
HYPOXIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
PLEURAL EFFUSION ^* 1	0/128 (0.00%)	0	5/127 (3.94%)	6
PNEUMOTHORAX ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
RES OTH BIBASAL INSPIRATORY CRACKLES ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
RES OTH BREATHLESSNESS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
RES OTH BRONCHITIS ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	3
RES OTH COPD ^* 1	1/128 (0.78%)	3	0/127 (0.00%)	0
RES OTH EMPYEMA ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
RES OTH PNEUMONIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
RES OTH PULMONARY EMPHYSEMA ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
RES OTH RHINORRHEA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
RES OTH RIGNT POSTERIOR PARIETAL PAIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
RES OTH SHORTNESS OF BREATH, PT ON CHEMO, NOT RELATED TO PRIMARY DISEASE TX ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
RES OTH THORACIC PAIN ^* 1	1/128 (0.78%)	1	1/127 (0.79%)	1
RESPIRATORY FAILURE ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
SLEEP APNEA ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
SORE THROAT ^* 1	0/128 (0.00%)	0	2/127 (1.57%)	2
VOICE ALTERATION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
Skin and subcutaneous tissue disorders
DRY SKIN ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
ERYTHEMA MULTIFORME ^* 1	0/128 (0.00%)	0	4/127 (3.15%)	4
HYPERHIDROSIS ^* 1	1/128 (0.78%)	1	1/127 (0.79%)	1
PRURITUS ^* 1	2/128 (1.56%)	2	6/127 (4.72%)	6
RASH ACNEIFORM ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
RASH MACULO-PAPULAR ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
SKI OTH EPITHELITIS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
SKI OTH CUTANEOUS ERUPTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
SKI OTH EPITHELITIS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	2
SKI OTH HYPERSENSITIVITY SCAR ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
SKI OTH ITCHING AREA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
SKI OTH KELOID SCAR ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
SKI OTH PSORIASIS ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
SKI OTH RASH ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
SKI OTH SCAR HYPERTROPHIA ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
SKI OTH SKIN AND SUBCUTANEOUS TISSUE (FOLLICULITIS) ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
SKI OTH SKIN IRRITATION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
SKI OTH TOXICODERMIA ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
SKIN INFECTION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
SKIN ULCERATION ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
Vascular disorders
HEMATOMA ^* 1	2/128 (1.56%)	2	0/127 (0.00%)	0
HOT FLASHES ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	2
HYPERTENSION ^* 1	10/128 (7.81%)	24	10/127 (7.87%)	30
HYPOTENSION ^* 1	4/128 (3.13%)	4	5/127 (3.94%)	9
SUPERFICIAL THROMBOPHLEBITIS ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	1
THROMBOEMBOLIC EVENT ^* 1	2/128 (1.56%)	2	7/127 (5.51%)	24
VAS OTH AORTIC ECTASIA ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
VAS OTH INFERIOR VENA CAVA SYNDROME ^* 1	0/128 (0.00%)	0	1/127 (0.79%)	9
VAS OTH PULMONARY EMBOLISM ^* 1	1/128 (0.78%)	5	0/127 (0.00%)	0
VASCULITIS ^* 1	1/128 (0.78%)	1	0/127 (0.00%)	0
1 Term from vocabulary, CTCAE_v4 * Indicates events were collected by non-systematic assessment

Limitations and Caveats

The trial is limited by the short follow-up. An update will be done in 5 years. The trial is not powered for a difference in survival.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	EORTC HEADQUARTERS
Organization:	EORTC (European Organisation for Research and Treatment of Cancer)
Phone:	+32 2 774 16 11
EMail:	eortc@eortc.be

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bonvalot S, Gronchi A, Le Pechoux C, Swallow CJ, Strauss D, Meeus P, van Coevorden F, Stoldt S, Stoeckle E, Rutkowski P, Rastrelli M, Raut CP, Hompes D, De Paoli A, Sangalli C, Honore C, Chung P, Miah A, Blay JY, Fiore M, Stelmes JJ, Dei Tos AP, Baldini EH, Litiere S, Marreaud S, Gelderblom H, Haas RL. Preoperative radiotherapy plus surgery versus surgery alone for patients with primary retroperitoneal sarcoma (EORTC-62092: STRASS): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1366-1377. doi: 10.1016/S1470-2045(20)30446-0. Epub 2020 Sep 14.

Layout table for additonal information

Responsible Party:	European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:	NCT01344018
Other Study ID Numbers:	EORTC-62092-22092 EORTC-62092 ( Other Identifier: EORTC ) EORTC-22092 ( Other Identifier: EORTC ) EU-21113 ( Other Identifier: EU )
First Submitted:	April 27, 2011
First Posted:	April 28, 2011
Results First Submitted:	September 20, 2021
Results First Posted:	April 24, 2023
Last Update Posted:	April 24, 2023

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