FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer (FOXFIREGlobal)

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ClinicalTrials.gov Identifier: NCT01721954

Recruitment Status : Completed

First Posted : November 6, 2012

Results First Posted : October 22, 2019

Last Update Posted : November 5, 2019

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Sponsor:

Information provided by (Responsible Party):

Sirtex Medical

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Colorectal Cancer Metastatic
Interventions	Drug: FOLFOX6m Device: SIR-Spheres microspheres
Enrollment	209

Participant Flow

Recruitment Details	Between 01May2013&24Dec2014,209 patients were screened&randomised from 87centres in Australia, Belgium,France, Germany, Israel, Italy, Korea, New Zealand, Portugal, Singapore, Spain,Taiwan &the US. 209 patients randomized in the Intent to treat (ITT) population. 5 patients who did not receive study medication were not included in safety population.
Pre-assignment Details


Arm/Group Title	mFOLFOX6 Plus SIRT	mFOLFOX6 Alone
Arm/Group Description	Systemic chemotherapy with FOLFOX6m...	Systemic chemotherapy with FOLFOX6m...
Arm/Group Description	Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres. FOLFOX6m SIR-Spheres microspheres	Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure. FOLFOX6m
Period Title: Overall Study
Started	105	104
Completed	35	35
Not Completed	70	69
Reason Not Completed
Death	58	64
Withdrawal by Subject	8	4
Adverse Event	2	0
Lost to Follow-up	2	1

Baseline Characteristics

Arm/Group Title		mFOLFOX6 Plus SIRT	mFOLFOX6 Alone	Total
Arm/Group Description		Systemic chemotherapy with FOLFOX6m...	Systemic chemotherapy with FOLFOX6m...	Total of all reporting groups
Arm/Group Description		Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres. FOLFOX6m SIR-Spheres microspheres	Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure. FOLFOX6m	Total of all reporting groups
Overall Number of Baseline Participants		105	104	209
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	105 participants	104 participants	209 participants
		62.6 (11.28)	62.4 (10.06)	62.5 (10.66)
Age, Customized Measure Type: Count of Participants Unit of measure: Participants
Age, Categorical	Number Analyzed	105 participants	104 participants	209 participants
	Below 65 years	60 57.1%	57 54.8%	117 56.0%
	Greater than or equal to 65 years	45 42.9%	47 45.2%	92 44.0%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	105 participants	104 participants	209 participants
	Female	41 39.0%	44 42.3%	85 40.7%
	Male	64 61.0%	60 57.7%	124 59.3%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	105 participants	104 participants	209 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	8 7.6%	6 5.8%	14 6.7%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	4 3.8%	2 1.9%	6 2.9%
	White	88 83.8%	93 89.4%	181 86.6%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	5 4.8%	3 2.9%	8 3.8%
WHO performance status ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	105 participants	104 participants	209 participants
	0	61 58.1%	53 51.0%	114 54.5%
	1	44 41.9%	50 48.1%	94 45.0%
	Unknown	0 0.0%	1 1.0%	1 0.5%
		[1] Measure Description: (0) Able to carry out all normal activity without restriction (1) Restricted in physically strenuous activity but ambulatory and able to carry out light work
Extra-hepatic Disease Measure Type: Number Unit of measure: Participants	Number Analyzed	105 participants	104 participants	209 participants
Yes		32	27	59
No		73	77	150
Liver Involvement % Measure Type: Number Unit of measure: Participants	Number Analyzed	105 participants	104 participants	209 participants
<=25%		74	74	148
>25%		31	30	61
Tumor volume Mean (Standard Deviation) Unit of measure: Percentage of liver
	Number Analyzed	105 participants	104 participants	209 participants
		18.5 (17.77)	17.9 (16.18)	18.2 (16.96)
ITT bevacizumab Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	105 participants	104 participants	209 participants
	Yes	87 82.9%	87 83.7%	174 83.3%
	No	18 17.1%	17 16.3%	35 16.7%

Outcome Measures

1.Primary Outcome


Title	Overall Survival (OS)
Description	OS defined as the time interval between the date of randomization and ...
Description	OS defined as the time interval between the date of randomization and the date of death from any cause.
Time Frame	From date of randomization until the date of death from any cause assessed up 3 yrs 8 months

Outcome Measure Data

Analysis Population Description

ITT population


Arm/Group Title	mFOLFOX6 Plus SIRT	mFOLFOX6 Alone
Arm/Group Description:	Systemic chemotherapy with FOLFOX6m...	Systemic chemotherapy with FOLFOX6m...
Arm/Group Description:	Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres. FOLFOX6m SIR-Spheres microspheres	Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure. FOLFOX6m
Overall Number of Participants Analyzed	105	104
Median (95% Confidence Interval) Unit of Measure: months
	25.9 (23.1 to 29.0)	25.0 (22.1 to 28.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	mFOLFOX6 Plus SIRT, mFOLFOX6 Alone
	Comments	The null hypothesis tested for the primary efficacy endpoint is overall survival (months) of SIRT/FOLFOX treatment versus FOLFOX is equal for both groups. The two-sided alternative hypothesis tested with 95% confidence is OS time for SIRT/FOLFOX treatment lower to that of FOLFOX.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.43
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.93
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Progression-free Survival
Description	PFS defined using Response Evaluation Criteria In Solid Tumors Criteri...
Description	PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.
Time Frame	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years 8 months.

Outcome Measure Data

Analysis Population Description

ITT population


Arm/Group Title	mFOLFOX6 Plus SIRT	mFOLFOX6 Alone
Arm/Group Description:	Systemic chemotherapy with FOLFOX6m...	Systemic chemotherapy with FOLFOX6m...
Arm/Group Description:	Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres. FOLFOX6m SIR-Spheres microspheres	Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure. FOLFOX6m
Overall Number of Participants Analyzed	105	104
Median (95% Confidence Interval) Unit of Measure: months
	11.8 (10.3 to 14.5)	11.2 (9.4 to 12.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	mFOLFOX6 Plus SIRT, mFOLFOX6 Alone
	Comments	A sample size of at least 209 patients for the SIRFLOX study was estimated to be needed to detect an increase in the median PFS at any site from 9.4 months to 14.5 months with 80% power and 95% confidence. Taking into account the number of patients who might receive the alternative treatment or lack of imaging data, the sample size was increased to 209. The Null hypothesis is no difference between the treatment arms with respect to PFS.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.75
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months.
Adverse Event Reporting Description	Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.

Arm/Group Title	mFOLFOX6 Plus SIRT	mFOLFOX6 Alone
Arm/Group Description	Systemic chemotherapy with FOLFOX6m...	Systemic chemotherapy with FOLFOX6m...
Arm/Group Description	Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres. FOLFOX6m SIR-Spheres microspheres	Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure. FOLFOX6m
All-Cause Mortality
	mFOLFOX6 Plus SIRT	mFOLFOX6 Alone
	Affected / at Risk (%)	Affected / at Risk (%)
Total	58/92 (63.04%)	64/112 (57.14%)
Serious Adverse Events Serious Adverse Events
	mFOLFOX6 Plus SIRT	mFOLFOX6 Alone
	Affected / at Risk (%)	Affected / at Risk (%)
Total	47/92 (51.09%)	47/112 (41.96%)
Blood and lymphatic system disorders
Febrile Neutropenia ^† 1	10/92 (10.87%)	3/112 (2.68%)
Neutropenia ^† 1	2/92 (2.17%)	1/112 (0.89%)
Pancytopenia ^† 1	2/92 (2.17%)	0/112 (0.00%)
Cardiac disorders
Acute Myocardial Infarction ^† 1	1/92 (1.09%)	0/112 (0.00%)
Arteriospasm Coronary ^† 1	1/92 (1.09%)	1/112 (0.89%)
Cardiac Failure ^† 1	0/92 (0.00%)	1/112 (0.89%)
Cardiotoxicity ^† 1	1/92 (1.09%)	0/112 (0.00%)
Eye disorders
Retinal Detachment ^† 1	0/92 (0.00%)	1/112 (0.89%)
Vitreous Haemorrhage ^† 1	1/92 (1.09%)	0/112 (0.00%)
Gastrointestinal disorders
Abdominal Pain ^† 1	9/92 (9.78%)	0/112 (0.00%)
Abdominal Pain Upper ^† 1	0/92 (0.00%)	1/112 (0.89%)
Anal Fissure ^† 1	0/92 (0.00%)	1/112 (0.89%)
Colitis ^† 1	0/92 (0.00%)	1/112 (0.89%)
Diarrhoea ^† 1	5/92 (5.43%)	5/112 (4.46%)
Duodenal Perforation ^† 1	1/92 (1.09%)	0/112 (0.00%)
Duodenal Ulcer Haemorrhage ^† 1	0/92 (0.00%)	1/112 (0.89%)
Enterocolitis ^† 1	1/92 (1.09%)	0/112 (0.00%)
Gastric Ulcer ^† 1	2/92 (2.17%)	0/112 (0.00%)
Gastritis ^† 1	1/92 (1.09%)	0/112 (0.00%)
Gastrointestinal Haemorrhage ^† 1	1/92 (1.09%)	0/112 (0.00%)
Haematemesis ^† 1	1/92 (1.09%)	0/112 (0.00%)
Intestinal Obstruction ^† 1	1/92 (1.09%)	2/112 (1.79%)
Intestinal Perforation ^† 1	0/92 (0.00%)	1/112 (0.89%)
Large Intestinal Obstruction ^† 1	0/92 (0.00%)	1/112 (0.89%)
Large Intestine Perforation ^† 1	0/92 (0.00%)	1/112 (0.89%)
Nausea ^† 1	1/92 (1.09%)	0/112 (0.00%)
Neutropenic Colitis ^† 1	0/92 (0.00%)	1/112 (0.89%)
Pancreatitis ^† 1	2/92 (2.17%)	0/112 (0.00%)
Small Intestinal Obstruction ^† 1	0/92 (0.00%)	1/112 (0.89%)
Varices Oesophageal ^† 1	0/92 (0.00%)	1/112 (0.89%)
Vomiting ^† 1	1/92 (1.09%)	1/112 (0.89%)
Constipation ^† 1	1/92 (1.09%)	0/112 (0.00%)
General disorders
Asthenia ^† 1	1/92 (1.09%)	0/112 (0.00%)
Chest Pain ^† 1	1/92 (1.09%)	0/112 (0.00%)
Fatigue ^† 1	1/92 (1.09%)	0/112 (0.00%)
General Physical Health Deterioration ^† 1	2/92 (2.17%)	2/112 (1.79%)
Malaise ^† 1	1/92 (1.09%)	1/112 (0.89%)
Mucosal Inflammation ^† 1	2/92 (2.17%)	0/112 (0.00%)
Pain ^† 1	1/92 (1.09%)	0/112 (0.00%)
Pyrexia ^† 1	2/92 (2.17%)	3/112 (2.68%)
Hepatobiliary disorders
Cholelithiasis ^† 1	1/92 (1.09%)	0/112 (0.00%)
Hepatic Cirrhosis ^† 1	1/92 (1.09%)	0/112 (0.00%)
Hepatic Failure ^† 1	2/92 (2.17%)	0/112 (0.00%)
Hyperbilirubinaemia ^† 1	1/92 (1.09%)	0/112 (0.00%)
Portal Hypertension ^† 1	0/92 (0.00%)	1/112 (0.89%)
Infections and infestations
Abdominal Sepsis ^† 1	0/92 (0.00%)	1/112 (0.89%)
Anal Abscess ^† 1	0/92 (0.00%)	1/112 (0.89%)
Campylobacter Gastroenteritis ^† 1	1/92 (1.09%)	0/112 (0.00%)
Cellulitis ^† 1	1/92 (1.09%)	0/112 (0.00%)
Clostridium Difficile Infection ^† 1	1/92 (1.09%)	0/112 (0.00%)
Device Related Infection ^† 1	1/92 (1.09%)	1/112 (0.89%)
Device Related Sepsis ^† 1	0/92 (0.00%)	1/112 (0.89%)
Enteritis Infectious ^† 1	0/92 (0.00%)	1/112 (0.89%)
Enterococcal Sepsis ^† 1	1/92 (1.09%)	0/112 (0.00%)
Escherichia Sepsis ^† 1	2/92 (2.17%)	0/112 (0.00%)
Escherichia Urinary Tract Infection ^† 1	1/92 (1.09%)	0/112 (0.00%)
Infection ^† 1	1/92 (1.09%)	1/112 (0.89%)
Infusion Site Cellulitis ^† 1	1/92 (1.09%)	0/112 (0.00%)
Infusion Site Infection ^† 1	0/92 (0.00%)	1/112 (0.89%)
Lower Respiratory Tract Infection ^† 1	1/92 (1.09%)	1/112 (0.89%)
Lung Abscess ^† 1	0/92 (0.00%)	1/112 (0.89%)
Neutropenic Sepsis ^† 1	1/92 (1.09%)	0/112 (0.00%)
Pelvic Abscess ^† 1	1/92 (1.09%)	0/112 (0.00%)
Peritonitis ^† 1	1/92 (1.09%)	0/112 (0.00%)
Peritonitis Bacterial ^† 1	1/92 (1.09%)	0/112 (0.00%)
Pneumonia ^† 1	6/92 (6.52%)	3/112 (2.68%)
Pseudomonal Bacteraemia ^† 1	1/92 (1.09%)	0/112 (0.00%)
Rectal Abscess ^† 1	1/92 (1.09%)	0/112 (0.00%)
Respiratory Tract Infection ^† 1	0/92 (0.00%)	1/112 (0.89%)
Sepsis ^† 1	2/92 (2.17%)	2/112 (1.79%)
Skin Bacterial Infection ^† 1	1/92 (1.09%)	0/112 (0.00%)
Upper Respiratory Tract Infection ^† 1	1/92 (1.09%)	0/112 (0.00%)
Urinary Tract Infection ^† 1	2/92 (2.17%)	2/112 (1.79%)
Injury, poisoning and procedural complications
Arterial Injury ^† 1	1/92 (1.09%)	0/112 (0.00%)
Gastrointestinal Stoma Complication ^† 1	0/92 (0.00%)	2/112 (1.79%)
Hip Fracture ^† 1	1/92 (1.09%)	0/112 (0.00%)
Intestinal Anastomosis Complication ^† 1	0/92 (0.00%)	1/112 (0.89%)
Thermal Burn ^† 1	0/92 (0.00%)	1/112 (0.89%)
Investigations
C-Reactive Protein Increased ^† 1	0/92 (0.00%)	1/112 (0.89%)
White Blood Cell Count Decreased ^† 1	1/92 (1.09%)	0/112 (0.00%)
Metabolism and nutrition disorders
Dehydration ^† 1	4/92 (4.35%)	0/112 (0.00%)
Diabetic Complication ^† 1	0/92 (0.00%)	1/112 (0.89%)
Diabetic Ketoacidosis ^† 1	0/92 (0.00%)	1/112 (0.89%)
Hypercalcaemia ^† 1	1/92 (1.09%)	0/112 (0.00%)
Hyperglycaemia ^† 1	0/92 (0.00%)	2/112 (1.79%)
Hypokalaemia ^† 1	1/92 (1.09%)	1/112 (0.89%)
Musculoskeletal and connective tissue disorders
Back Pain ^† 1	0/92 (0.00%)	2/112 (1.79%)
Groin Pain ^† 1	0/92 (0.00%)	1/112 (0.89%)
Muscle Haemorrhage ^† 1	1/92 (1.09%)	0/112 (0.00%)
Pain In Extremity ^† 1	0/92 (0.00%)	1/112 (0.89%)
Pathological Fracture ^† 1	0/92 (0.00%)	1/112 (0.89%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Meninges ^† 1	0/92 (0.00%)	1/112 (0.89%)
Nervous system disorders
Hepatic Encephalopathy ^† 1	2/92 (2.17%)	0/112 (0.00%)
Mental Impairment ^† 1	1/92 (1.09%)	0/112 (0.00%)
Presyncope ^† 1	0/92 (0.00%)	1/112 (0.89%)
Syncope ^† 1	1/92 (1.09%)	1/112 (0.89%)
Psychiatric disorders
Acute Psychosis ^† 1	1/92 (1.09%)	0/112 (0.00%)
Confusional State ^† 1	1/92 (1.09%)	2/112 (1.79%)
Delirium ^† 1	1/92 (1.09%)	1/112 (0.89%)
Renal and urinary disorders
Renal Failure Acute ^† 1	0/92 (0.00%)	1/112 (0.89%)
Renal Injury ^† 1	0/92 (0.00%)	1/112 (0.89%)
Urinary Retention ^† 1	1/92 (1.09%)	0/112 (0.00%)
Respiratory, thoracic and mediastinal disorders
Asthma ^† 1	1/92 (1.09%)	0/112 (0.00%)
Dyspnoea ^† 1	1/92 (1.09%)	1/112 (0.89%)
Epistaxis ^† 1	0/92 (0.00%)	1/112 (0.89%)
Haemoptysis ^† 1	0/92 (0.00%)	1/112 (0.89%)
Pneumonia Aspiration ^† 1	0/92 (0.00%)	1/112 (0.89%)
Pneumonitis ^† 1	0/92 (0.00%)	1/112 (0.89%)
Pulmonary Embolism ^† 1	5/92 (5.43%)	0/112 (0.00%)
Skin and subcutaneous tissue disorders
Decubitus Ulcer ^† 1	1/92 (1.09%)	0/112 (0.00%)
Vascular disorders
Artery Dissection ^† 1	1/92 (1.09%)	0/112 (0.00%)
Deep Vein Thrombosis ^† 1	0/92 (0.00%)	1/112 (0.89%)
Jugular Vein Thrombosis ^† 1	0/92 (0.00%)	1/112 (0.89%)
Orthostatic Hypotensio ^† 1	1/92 (1.09%)	1/112 (0.89%)
Peripheral Artery Thrombosis ^† 1	1/92 (1.09%)	0/112 (0.00%)
Vena Cava Thrombosis ^† 1	0/92 (0.00%)	1/112 (0.89%)
1 Term from vocabulary, MedDRA version 16.1 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	mFOLFOX6 Plus SIRT	mFOLFOX6 Alone
	Affected / at Risk (%)	Affected / at Risk (%)
Total	92/92 (100.00%)	111/112 (99.11%)
Blood and lymphatic system disorders
Neutropenia ^† 1	43/92 (46.74%)	46/112 (41.07%)
Thrombocytopenia ^† 1	39/92 (42.39%)	11/112 (9.82%)
Anaemia ^† 1	21/92 (22.83%)	15/112 (13.39%)
Leukopenia ^† 1	13/92 (14.13%)	10/112 (8.93%)
Lymphopenia ^† 1	6/92 (6.52%)	1/112 (0.89%)
Eye disorders
Lacrimation Increased ^† 1	2/92 (2.17%)	6/112 (5.36%)
Gastrointestinal disorders
Nausea ^† 1	46/92 (50.00%)	55/112 (49.11%)
Diarrhoea ^† 1	35/92 (38.04%)	59/112 (52.68%)
Constipation ^† 1	39/92 (42.39%)	45/112 (40.18%)
Abdominal Pain ^† 1	33/92 (35.87%)	24/112 (21.43%)
Vomiting ^† 1	24/92 (26.09%)	33/112 (29.46%)
Stomatitis ^† 1	21/92 (22.83%)	29/112 (25.89%)
Abdominal Pain Upper ^† 1	20/92 (21.74%)	12/112 (10.71%)
Gastrooesophageal Reflux Disease ^† 1	7/92 (7.61%)	14/112 (12.50%)
Mouth Ulceration ^† 1	4/92 (4.35%)	14/112 (12.50%)
Abdominal Distension ^† 1	9/92 (9.78%)	7/112 (6.25%)
Rectal Haemorrhage ^† 1	7/92 (7.61%)	7/112 (6.25%)
Dry Mouth ^† 1	3/92 (3.26%)	9/112 (8.04%)
Ascites ^† 1	9/92 (9.78%)	1/112 (0.89%)
Dyspepsia ^† 1	5/92 (5.43%)	5/112 (4.46%)
Gastritis ^† 1	5/92 (5.43%)	1/112 (0.89%)
General disorders
Fatigue ^† 1	48/92 (52.17%)	49/112 (43.75%)
Mucosal Inflammation ^† 1	12/92 (13.04%)	23/112 (20.54%)
Asthenia ^† 1	15/92 (16.30%)	18/112 (16.07%)
Pyrexia ^† 1	17/92 (18.48%)	16/112 (14.29%)
Oedema Peripheral ^† 1	13/92 (14.13%)	6/112 (5.36%)
Pain ^† 1	3/92 (3.26%)	8/112 (7.14%)
Chest Pain ^† 1	1/92 (1.09%)	8/112 (7.14%)
Infections and infestations
Urinary Tract Infection ^† 1	9/92 (9.78%)	10/112 (8.93%)
Upper Respiratory Tract Infection ^† 1	10/92 (10.87%)	8/112 (7.14%)
Nasopharyngitis ^† 1	2/92 (2.17%)	8/112 (7.14%)
Bronchitis ^† 1	1/92 (1.09%)	6/112 (5.36%)
Injury, poisoning and procedural complications
Contusion ^† 1	5/92 (5.43%)	3/112 (2.68%)
Fall ^† 1	5/92 (5.43%)	2/112 (1.79%)
Investigations
Weight Decreased ^† 1	29/92 (31.52%)	19/112 (16.96%)
Neutrophil Count Decreased ^† 1	7/92 (7.61%)	8/112 (7.14%)
Weight Increased ^† 1	5/92 (5.43%)	9/112 (8.04%)
Platelet Count Decreased ^† 1	9/92 (9.78%)	4/112 (3.57%)
Aspartate Aminotransferase Increased ^† 1	9/92 (9.78%)	2/112 (1.79%)
Blood Alkaline Phosphatase Increased ^† 1	6/92 (6.52%)	5/112 (4.46%)
White Blood Cell Count Decreased ^† 1	7/92 (7.61%)	4/112 (3.57%)
Blood Bilirubin Increased ^† 1	5/92 (5.43%)	3/112 (2.68%)
Alanine Aminotransferase Increased ^† 1	6/92 (6.52%)	1/112 (0.89%)
Blood Albumin Decreased ^† 1	5/92 (5.43%)	2/112 (1.79%)
Metabolism and nutrition disorders
Decreased Appetite ^† 1	25/92 (27.17%)	30/112 (26.79%)
Hypokalaemia ^† 1	11/92 (11.96%)	13/112 (11.61%)
Dehydration ^† 1	5/92 (5.43%)	7/112 (6.25%)
Hypomagnesaemia ^† 1	3/92 (3.26%)	9/112 (8.04%)
Hyperglycaemia ^† 1	5/92 (5.43%)	6/112 (5.36%)
Hypoalbuminaemia ^† 1	8/92 (8.70%)	3/112 (2.68%)
Musculoskeletal and connective tissue disorders
Back Pain ^† 1	9/92 (9.78%)	14/112 (12.50%)
Musculoskeletal Pain ^† 1	5/92 (5.43%)	12/112 (10.71%)
Pain In Extremity ^† 1	13/92 (14.13%)	4/112 (3.57%)
Arthralgia ^† 1	3/92 (3.26%)	8/112 (7.14%)
Muscle Spasms ^† 1	3/92 (3.26%)	7/112 (6.25%)
Nervous system disorders
Neuropathy peripheral ^† 1	54/92 (58.70%)	55/112 (49.11%)
Peripheral sensory neuropathy ^† 1	16/92 (17.39%)	29/112 (25.89%)
Headache ^† 1	13/92 (14.13%)	21/112 (18.75%)
Paraesthesia ^† 1	15/92 (16.30%)	19/112 (16.96%)
Dysgeusia ^† 1	17/92 (18.48%)	10/112 (8.93%)
Dizziness ^† 1	8/92 (8.70%)	6/112 (5.36%)
Psychiatric disorders
Insomnia ^† 1	16/92 (17.39%)	15/112 (13.39%)
Anxiety ^† 1	8/92 (8.70%)	12/112 (10.71%)
Renal and urinary disorders
Dysuria ^† 1	1/92 (1.09%)	6/112 (5.36%)
Respiratory, thoracic and mediastinal disorders
Epistaxis ^† 1	20/92 (21.74%)	27/112 (24.11%)
Cough ^† 1	12/92 (13.04%)	13/112 (11.61%)
Dyspnoea ^† 1	10/92 (10.87%)	12/112 (10.71%)
Dysphonia ^† 1	3/92 (3.26%)	10/112 (8.93%)
Oropharyngeal Pain ^† 1	3/92 (3.26%)	8/112 (7.14%)
Rhinorrhoea ^† 1	4/92 (4.35%)	7/112 (6.25%)
Pulmonary Embolism ^† 1	3/92 (3.26%)	7/112 (6.25%)
Hiccups ^† 1	7/92 (7.61%)	0/112 (0.00%)
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome ^† 1	11/92 (11.96%)	19/112 (16.96%)
Rash ^† 1	13/92 (14.13%)	11/112 (9.82%)
Alopecia ^† 1	7/92 (7.61%)	15/112 (13.39%)
Dry Skin ^† 1	4/92 (4.35%)	11/112 (9.82%)
Pruritus ^† 1	2/92 (2.17%)	7/112 (6.25%)
Vascular disorders
Hypertension ^† 1	15/92 (16.30%)	28/112 (25.00%)
1 Term from vocabulary, MedDRA version 16.1 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

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

Layout table for Results Point of Contact information

Name/Title:	Janet Bell, M.B.A.
Organization:	Sirtex Medical
Phone:	+ 888-474-7839 ext 710
EMail:	jbell@sirtex.com

Publications of Results:

van Hazel GA, Heinemann V, Sharma NK, Findlay MP, Ricke J, Peeters M, Perez D, Robinson BA, Strickland AH, Ferguson T, Rodriguez J, Kroning H, Wolf I, Ganju V, Walpole E, Boucher E, Tichler T, Shacham-Shmueli E, Powell A, Eliadis P, Isaacs R, Price D, Moeslein F, Taieb J, Bower G, Gebski V, Van Buskirk M, Cade DN, Thurston K, Gibbs P. SIRFLOX: Randomized Phase III Trial Comparing First-Line mFOLFOX6 (Plus or Minus Bevacizumab) Versus mFOLFOX6 (Plus or Minus Bevacizumab) Plus Selective Internal Radiation Therapy in Patients With Metastatic Colorectal Cancer. J Clin Oncol. 2016 May 20;34(15):1723-31. doi: 10.1200/JCO.2015.66.1181. Epub 2016 Feb 22. Erratum In: J Clin Oncol. 2016 Nov 20;34(33):4059.

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

Wolstenholme J, Fusco F, Gray AM, Moschandreas J, Virdee PS, Love S, Van Hazel G, Gibbs P, Wasan HS, Sharma RA. Quality of life in the FOXFIRE, SIRFLOX and FOXFIRE-global randomised trials of selective internal radiotherapy for metastatic colorectal cancer. Int J Cancer. 2020 Aug 15;147(4):1078-1085. doi: 10.1002/ijc.32828. Epub 2020 Jan 9.

Wasan HS, Gibbs P, Sharma NK, Taieb J, Heinemann V, Ricke J, Peeters M, Findlay M, Weaver A, Mills J, Wilson C, Adams R, Francis A, Moschandreas J, Virdee PS, Dutton P, Love S, Gebski V, Gray A; FOXFIRE trial investigators; SIRFLOX trial investigators; FOXFIRE-Global trial investigators; van Hazel G, Sharma RA. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials. Lancet Oncol. 2017 Sep;18(9):1159-1171. doi: 10.1016/S1470-2045(17)30457-6. Epub 2017 Aug 3.

Virdee PS, Moschandreas J, Gebski V, Love SB, Francis EA, Wasan HS, van Hazel G, Gibbs P, Sharma RA. Protocol for Combined Analysis of FOXFIRE, SIRFLOX, and FOXFIRE-Global Randomized Phase III Trials of Chemotherapy +/- Selective Internal Radiation Therapy as First-Line Treatment for Patients With Metastatic Colorectal Cancer. JMIR Res Protoc. 2017 Mar 28;6(3):e43. doi: 10.2196/resprot.7201.

Layout table for additonal information

Responsible Party:	Sirtex Medical
ClinicalTrials.gov Identifier:	NCT01721954
Other Study ID Numbers:	STX0112
First Submitted:	October 26, 2012
First Posted:	November 6, 2012
Results First Submitted:	August 12, 2019
Results First Posted:	October 22, 2019
Last Update Posted:	November 5, 2019

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