Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT00942357

Recruitment Status : Active, not recruiting

First Posted : July 20, 2009

Results First Posted : December 19, 2018

Last Update Posted : October 19, 2021

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Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

GOG Foundation ( Gynecologic Oncology Group )

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Endometrial Clear Cell Adenocarcinoma Endometrial Serous Adenocarcinoma Stage IA Uterine Corpus Cancer AJCC v7 Stage IB Uterine Corpus Cancer AJCC v7 Stage II Uterine Corpus Cancer AJCC v7 Stage IIIA Uterine Corpus Cancer AJCC v7 Stage IIIB Uterine Corpus Cancer AJCC v7 Stage IIIC Uterine Corpus Cancer AJCC v7 Stage IVA Uterine Corpus Cancer AJCC v7
Interventions	Drug: Carboplatin Drug: Cisplatin Radiation: Internal Radiation Therapy Drug: Paclitaxel Other: Quality-of-Life Assessment Radiation: Radiation Therapy
Enrollment	813

Participant Flow

Recruitment Details	GOG 0258 accrued 813 patients between June 29, 2009 and July 28, 2014.
Pre-assignment Details


Arm/Group Title	Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	Arm II (Paclitaxel and Carboplatin)
Arm/Group Description	Patients receive cisplatin IV on da...	Patients receive paclitaxel IV over...
Arm/Group Description	Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Internal Radiation Therapy: Undergo brachytherapy Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo radiation therapy	Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
Period Title: Overall Study
Started	407	406
Completed	370	366
Not Completed	37	40
Reason Not Completed
Ineligible	37	40

Baseline Characteristics

Arm/Group Title		Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	Arm II (Paclitaxel and Carboplatin)	Total
Arm/Group Description		Patients receive cisplatin IV on da...	Patients receive paclitaxel IV over...	Total of all reporting groups
Arm/Group Description		Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Internal Radiation Therapy: Undergo brachytherapy Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo radiation therapy	Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Total of all reporting groups
Overall Number of Baseline Participants		370	366	736
Baseline Analysis Population Description		...
Baseline Analysis Population Description		All eligible and treated patients
Age, Customized Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	370 participants	366 participants	736 participants
20-29 years		0 0.0%	0 0.0%	0 0.0%
30-39 years		6 1.6%	10 2.7%	16 2.2%
40-49 years		36 9.7%	31 8.5%	67 9.1%
50-59 years		132 35.7%	136 37.2%	268 36.4%
60-69 years		133 35.9%	130 35.5%	263 35.7%
70-79 years		55 14.9%	51 13.9%	106 14.4%
80-89 years		8 2.2%	8 2.2%	16 2.2%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	370 participants	366 participants	736 participants
	Female	370 100.0%	366 100.0%	736 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	370 participants	366 participants	736 participants
	Hispanic or Latino	15 4.1%	29 7.9%	44 6.0%
	Not Hispanic or Latino	338 91.4%	324 88.5%	662 89.9%
	Unknown or Not Reported	17 4.6%	13 3.6%	30 4.1%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	370 participants	366 participants	736 participants
	American Indian or Alaska Native	2 0.5%	3 0.8%	5 0.7%
	Asian	33 8.9%	34 9.3%	67 9.1%
	Native Hawaiian or Other Pacific Islander	2 0.5%	2 0.5%	4 0.5%
	Black or African American	37 10.0%	42 11.5%	79 10.7%
	White	291 78.6%	279 76.2%	570 77.4%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	5 1.4%	6 1.6%	11 1.5%
Endometrial Cancer Grades ^[1] Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	370 participants	366 participants	736 participants
Endometrioid Grade 1		87 23.5%	79 21.6%	166 22.6%
Endometrioid Grade 2		103 27.8%	118 32.2%	221 30.0%
Endometrioid Grade 3		66 17.8%	62 16.9%	128 17.4%
Serous		66 17.8%	65 17.8%	131 17.8%
Clear Cell		10 2.7%	12 3.3%	22 3.0%
Other		38 10.3%	30 8.2%	68 9.2%
		[1] Measure Description: Grade 1 is 5% or less of a non-squamous or non-morular solid growth pattern. Grade 2 is 6 through 50% of a non squamous or non-morular solid growth pattern. Grade 3 is more than 50% of a non-squamous or non-morular solid growth pattern. Generally the higher the stage the worse the outcome.

Outcome Measures

1.Primary Outcome


Title	Number of Participants With Recurrence, Progression or Death
Description	Number of participants enrolled with recurrence or progression of dise...
Description	Number of participants enrolled with recurrence or progression of disease or death up to date of last contact. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions.
Time Frame	Disease was to be assessed at baseline, end of treatment and every 6 months for two years, and annually up to 5 years.

Outcome Measure Data

Analysis Population Description

Number of recurrence, progression or death events in eligible and enrolled patients


Arm/Group Title	Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	Arm II (Paclitaxel and Carboplatin)
Arm/Group Description:	Patients receive cisplatin IV on da...	Patients receive paclitaxel IV over...
Arm/Group Description:	Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Internal Radiation Therapy: Undergo brachytherapy Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo radiation therapy	Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
Overall Number of Participants Analyzed	370	366
Measure Type: Number Unit of Measure: participants
	132	139

2.Secondary Outcome


Title	Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0
Description	The maximum grade of all treatment emergent adverse events without reg...
Description	The maximum grade of all treatment emergent adverse events without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death.
Time Frame	Assessed throughout the treatment period and for 21-30 days after discontinuation of treatment

Outcome Measure Data

Analysis Population Description

Eligible and treated participants


Arm/Group Title	Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	Arm II (Paclitaxel and Carboplatin)
Arm/Group Description:	Patients receive cisplatin IV on da...	Patients receive paclitaxel IV over...
Arm/Group Description:	Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Internal Radiation Therapy: Undergo brachytherapy Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo radiation therapy	Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
Overall Number of Participants Analyzed	346	361
Measure Type: Count of Participants Unit of Measure: Participants
Grade 1	5 1.4%	15 4.2%
Grade 2	139 40.2%	118 32.7%
Grade 3	154 44.5%	119 33.0%
Grade 4	48 13.9%	105 29.1%
Grade 5	0 0.0%	3 0.8%

3.Secondary Outcome


Title	Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0
Description	The maximum grade of Adverse events reported during follow-up until pr...
Description	The maximum grade of Adverse events reported during follow-up until progression of disease, a change of therapy or otherwise off study for a maximum of 3 years without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death.
Time Frame	Assessed every 6 months for 3 years

Outcome Measure Data

Analysis Population Description

All eligible and treated patients


Arm/Group Title	Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	Arm II (Paclitaxel and Carboplatin)
Arm/Group Description:	Patients receive cisplatin IV on da...	Patients receive paclitaxel IV over...
Arm/Group Description:	Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Internal Radiation Therapy: Undergo brachytherapy Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo radiation therapy	Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
Overall Number of Participants Analyzed	346	361
Measure Type: Count of Participants Unit of Measure: Participants
Grade 1	85 24.6%	96 26.6%
Grade 2	71 20.5%	79 21.9%
Grade 3	45 13.0%	33 9.1%
Grade 4	14 4.0%	7 1.9%
Grade 5	1 0.3%	4 1.1%

4.Secondary Outcome


Title	Overall Survival
Description	Independence between the two endpoints, RFS and survival, and randomiz...
Description	Independence between the two endpoints, RFS and survival, and randomized treatment will be assessed with a stratified logrank test for an intent-to-treat analysis of eligible patients.
Time Frame	From entry into the study to death or the date of last contact, assessed up to 8 years

Outcome Measure Data Not Reported

5.Secondary Outcome


Title	Patient-reported Peripheral Neuropathy Symptoms
Description	Patient reported peripheral neuropathy symptoms was measured with the ...
Description	Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less peripheral neuropathy symptoms.
Time Frame	Prior to study treatment (baseline), Arm 1: 1 week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatement, 70 weeks post the starting of study treatment

Outcome Measure Data

Analysis Population Description

Patients who provided baseline and >= 1 follow-up assessment(s)


Arm/Group Title	Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	Arm II (Paclitaxel and Carboplatin)
Arm/Group Description:	Patients receive cisplatin IV on da...	Patients receive paclitaxel IV over...
Arm/Group Description:	Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Internal Radiation Therapy: Undergo brachytherapy Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo radiation therapy	Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
Overall Number of Participants Analyzed	332	349
Least Squares Mean (Standard Error) Unit of Measure: unit on a scale
Baseline	14.9 (0.1)	15.0 (0.1)
6 weeks	14.4 (0.4)	12.4 (0.4)
18 weeks	10.4 (0.4)	9.9 (0.5)
70 weeks	11.8 (0.4)	11.6 (0.4)

6.Secondary Outcome


Title	Patient-reported Quality of Life (QOL)
Description	Patient reported quality of life was measured with the Treatment Outco...
Description	Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). It is a scale for assessing general QOL of endometrial cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Endometrium Cancer subscale (16 items). Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The FACT-En TOI score is calculated as the sum of the subscale scores, ranges are 0-120 with a large score suggesting a better QOL.
Time Frame	Prior to study treatment (baseline), Arm 1: 1 Week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatment, 70 weeks post the starting of study treatment

Outcome Measure Data

Analysis Population Description

Patients who provided baseline and >= 1 follow-up assessments


Arm/Group Title	Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	Arm II (Paclitaxel and Carboplatin)
Arm/Group Description:	Patients receive cisplatin IV on da...	Patients receive paclitaxel IV over...
Arm/Group Description:	Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Internal Radiation Therapy: Undergo brachytherapy Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo radiation therapy	Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
Overall Number of Participants Analyzed	332	349
Least Squares Mean (Standard Error) Unit of Measure: units on a scale
Baseline	98.4 (0.8)	97.6 (0.8)
6 weeks	89.5 (2.1)	90.9 (2.0)
18 weeks	87.8 (2.1)	93.0 (2.0)
70 weeks	96.0 (2.2)	99.4 (2.1)

Adverse Events

Time Frame	All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Adverse Event Reporting Description	All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.

Arm/Group Title	Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	Arm II (Paclitaxel and Carboplatin)
Arm/Group Description	Patients receive cisplatin IV on da...	Patients receive paclitaxel IV over...
Arm/Group Description	Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Internal Radiation Therapy: Undergo brachytherapy Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo radiation therapy	Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
All-Cause Mortality
	Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	Arm II (Paclitaxel and Carboplatin)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0
Serious Adverse Events Serious Adverse Events
	Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	Arm II (Paclitaxel and Carboplatin)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	78/346 (22.54%)	61/361 (16.90%)
Blood and lymphatic system disorders
Neutrophils ^* 1	5/346 (1.45%)	27/361 (7.48%)
Platelets ^* 1	0/346 (0.00%)	2/361 (0.55%)
Blood/Bone Marrow - Other ^* 1	1/346 (0.29%)	1/361 (0.28%)
Lymphopenia ^* 1	6/346 (1.73%)	0/361 (0.00%)
Hemoglobin ^* 1	4/346 (1.16%)	2/361 (0.55%)
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation ^* 1	2/346 (0.58%)	1/361 (0.28%)
S/N Arrhythmia: Sinus Tachycardia ^* 1	0/346 (0.00%)	1/361 (0.28%)
Vasovagal Episode ^* 1	0/346 (0.00%)	1/361 (0.28%)
Hypotension ^* 1	1/346 (0.29%)	1/361 (0.28%)
Ear and labyrinth disorders
Auditory/Ear - Other ^* 1	0/346 (0.00%)	1/361 (0.28%)
Eye disorders
Uveitis ^* 1	1/346 (0.29%)	0/361 (0.00%)
Gastrointestinal disorders
Enteritis ^* 1	1/346 (0.29%)	0/361 (0.00%)
Obstruction, Gi - Ileum ^* 1	1/346 (0.29%)	0/361 (0.00%)
Obstruction, Gi - Rectum ^* 1	1/346 (0.29%)	0/361 (0.00%)
Ileus ^* 1	1/346 (0.29%)	0/361 (0.00%)
Obstruction, Gi - Small Bowel Nos ^* 1	3/346 (0.87%)	0/361 (0.00%)
Anorexia ^* 1	1/346 (0.29%)	0/361 (0.00%)
Dehydration ^* 1	2/346 (0.58%)	1/361 (0.28%)
Nausea ^* 1	1/346 (0.29%)	1/361 (0.28%)
Diarrhea ^* 1	9/346 (2.60%)	1/361 (0.28%)
General disorders
Fever ^* 1	2/346 (0.58%)	0/361 (0.00%)
Fatigue ^* 1	1/346 (0.29%)	0/361 (0.00%)
Death No Ctcae Term - Disease Progression Nos ^* 1	0/346 (0.00%)	1/361 (0.28%)
Death No Ctcae Term - Death Nos ^* 1	0/346 (0.00%)	1/361 (0.28%)
Pain: Head/Headache ^* 1	1/346 (0.29%)	0/361 (0.00%)
Pain: Back ^* 1	2/346 (0.58%)	0/361 (0.00%)
Pain: Abdominal Pain Nos ^* 1	1/346 (0.29%)	2/361 (0.55%)
Pain: Cardiac/ Heart ^* 1	1/346 (0.29%)	1/361 (0.28%)
Pain: Neuralgia ^* 1	0/346 (0.00%)	1/361 (0.28%)
Hepatobiliary disorders
Pancreatitis ^* 1	0/346 (0.00%)	1/361 (0.28%)
Immune system disorders
Allergic Reaction/Hypersensitivity ^* 1	3/346 (0.87%)	2/361 (0.55%)
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Blood ^* 1	1/346 (0.29%)	1/361 (0.28%)
Inf W/Nml Or Gr 1 Or 2 Anc: Blood ^* 1	0/346 (0.00%)	2/361 (0.55%)
Inf W/Nml Or Gr 1 Or 2 Anc: Wound ^* 1	1/346 (0.29%)	0/361 (0.00%)
Febrile Neutropenia ^* 1	1/346 (0.29%)	2/361 (0.55%)
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos ^* 1	1/346 (0.29%)	0/361 (0.00%)
Inf Unknown Anc: Blood ^* 1	1/346 (0.29%)	2/361 (0.55%)
Infection - Other ^* 1	3/346 (0.87%)	1/361 (0.28%)
Inf Unknown Anc: Pelvis Nos ^* 1	1/346 (0.29%)	0/361 (0.00%)
Inf Unknown Anc: Lymphatic ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf Unknown Anc: Kidney ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf Unknown Anc: Wound ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf W/Gr 3 Or 4 Anc: Pelvis Nos ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos ^* 1	0/346 (0.00%)	1/361 (0.28%)
Metabolism and nutrition disorders
Creatinine ^* 1	1/346 (0.29%)	0/361 (0.00%)
Alt ^* 1	1/346 (0.29%)	0/361 (0.00%)
Hyponatremia ^* 1	2/346 (0.58%)	0/361 (0.00%)
Hyperglycemia ^* 1	1/346 (0.29%)	1/361 (0.28%)
Hypokalemia ^* 1	2/346 (0.58%)	0/361 (0.00%)
Hypoglycemia ^* 1	1/346 (0.29%)	0/361 (0.00%)
Hypomagnesemia ^* 1	1/346 (0.29%)	1/361 (0.28%)
Musculoskeletal and connective tissue disorders
Arthritis ^* 1	1/346 (0.29%)	0/361 (0.00%)
Muscle Weakness - Extremity-Lower ^* 1	2/346 (0.58%)	0/361 (0.00%)
Nervous system disorders
Syncope ^* 1	2/346 (0.58%)	0/361 (0.00%)
Psychosis ^* 1	1/346 (0.29%)	0/361 (0.00%)
Neurology - Other ^* 1	1/346 (0.29%)	0/361 (0.00%)
Seizure ^* 1	1/346 (0.29%)	0/361 (0.00%)
Renal and urinary disorders
Obstruction, Gu - Ureter ^* 1	1/346 (0.29%)	0/361 (0.00%)
Renal Failure ^* 1	3/346 (0.87%)	0/361 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnea ^* 1	1/346 (0.29%)	0/361 (0.00%)
Skin and subcutaneous tissue disorders
Urticaria ^* 1	1/346 (0.29%)	0/361 (0.00%)
Vascular disorders
Hemorrhage, Gi - Rectum ^* 1	1/346 (0.29%)	0/361 (0.00%)
Thrombosis/Thrombus/Embolism ^* 1	6/346 (1.73%)	6/361 (1.66%)
1 Term from vocabulary, CTCAE (3.0) * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	Arm II (Paclitaxel and Carboplatin)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	346/346 (100.00%)	360/361 (99.72%)
Blood and lymphatic system disorders
Neutrophils ^* 1	176/346 (50.87%)	246/361 (68.14%)
Platelets ^* 1	217/346 (62.72%)	195/361 (54.02%)
Blood/Bone Marrow - Other ^* 1	12/346 (3.47%)	19/361 (5.26%)
Bone Marrow Cellularity ^* 1	0/346 (0.00%)	1/361 (0.28%)
Leukocytes ^* 1	287/346 (82.95%)	262/361 (72.58%)
Lymphopenia ^* 1	53/346 (15.32%)	21/361 (5.82%)
Hemolysis ^* 1	0/346 (0.00%)	1/361 (0.28%)
Hemoglobin ^* 1	309/346 (89.31%)	292/361 (80.89%)
Lymphatics - Other ^* 1	0/346 (0.00%)	1/361 (0.28%)
Lymphocele ^* 1	1/346 (0.29%)	2/361 (0.55%)
Edema: Trunk/Genital ^* 1	2/346 (0.58%)	1/361 (0.28%)
Edema: Limb ^* 1	56/346 (16.18%)	51/361 (14.13%)
Edema: Head And Neck ^* 1	2/346 (0.58%)	3/361 (0.83%)
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation ^* 1	2/346 (0.58%)	1/361 (0.28%)
Palpitations ^* 1	14/346 (4.05%)	7/361 (1.94%)
Cardiac Arrhythmia - Other ^* 1	0/346 (0.00%)	1/361 (0.28%)
Ventricular Arrhythmia - Tachycardia ^* 1	3/346 (0.87%)	0/361 (0.00%)
S/N Arrhythmia: Atrial Flutter ^* 1	1/346 (0.29%)	0/361 (0.00%)
S/N Arrhythmia: Sinus Tachycardia ^* 1	11/346 (3.18%)	8/361 (2.22%)
Supraventricular Tachycardia ^* 1	1/346 (0.29%)	0/361 (0.00%)
S/N Arrhythmia: Sinus Bradycardia ^* 1	1/346 (0.29%)	0/361 (0.00%)
S/N Arrhythmia: Atrial Tachycardia ^* 1	0/346 (0.00%)	1/361 (0.28%)
Cardiac Ischemia/Infarction ^* 1	1/346 (0.29%)	0/361 (0.00%)
Hypertension ^* 1	24/346 (6.94%)	46/361 (12.74%)
Valvular Heart Disease ^* 1	1/346 (0.29%)	0/361 (0.00%)
Cardiac General - Other ^* 1	2/346 (0.58%)	1/361 (0.28%)
Pericarditis ^* 1	1/346 (0.29%)	0/361 (0.00%)
Hypotension ^* 1	6/346 (1.73%)	10/361 (2.77%)
Ear and labyrinth disorders
Auditory/Ear - Other ^* 1	2/346 (0.58%)	2/361 (0.55%)
Hearing (Without Monitoring Program) ^* 1	4/346 (1.16%)	2/361 (0.55%)
Tinnitus ^* 1	18/346 (5.20%)	13/361 (3.60%)
Endocrine disorders
Hot Flashes ^* 1	38/346 (10.98%)	38/361 (10.53%)
Diabetes ^* 1	1/346 (0.29%)	0/361 (0.00%)
Endocrine - Other ^* 1	0/346 (0.00%)	1/361 (0.28%)
Eye disorders
Retinopathy ^* 1	0/346 (0.00%)	1/361 (0.28%)
Ocular/Visual - Other ^* 1	3/346 (0.87%)	2/361 (0.55%)
Vitreous Hemorrhage ^* 1	1/346 (0.29%)	0/361 (0.00%)
Watery Eye ^* 1	1/346 (0.29%)	3/361 (0.83%)
Dry Eye ^* 1	3/346 (0.87%)	1/361 (0.28%)
Ocular Surface Disease ^* 1	0/346 (0.00%)	1/361 (0.28%)
Cataract ^* 1	0/346 (0.00%)	2/361 (0.55%)
Photophobia ^* 1	2/346 (0.58%)	0/361 (0.00%)
Flashing Lights/Floaters ^* 1	3/346 (0.87%)	6/361 (1.66%)
Diplopia ^* 1	0/346 (0.00%)	2/361 (0.55%)
Blurred Vision ^* 1	19/346 (5.49%)	25/361 (6.93%)
Gastrointestinal disorders
Enteritis ^* 1	0/346 (0.00%)	1/361 (0.28%)
Proctitis ^* 1	6/346 (1.73%)	0/361 (0.00%)
Flatulence ^* 1	8/346 (2.31%)	5/361 (1.39%)
Ulcer,gi - Stoma ^* 1	1/346 (0.29%)	0/361 (0.00%)
Esophagitis ^* 1	0/346 (0.00%)	1/361 (0.28%)
Hemorrhoids ^* 1	13/346 (3.76%)	3/361 (0.83%)
Heartburn ^* 1	27/346 (7.80%)	22/361 (6.09%)
Dental: Teeth ^* 1	0/346 (0.00%)	1/361 (0.28%)
Mucositis (Functional/Sympt) - Pharynx ^* 1	0/346 (0.00%)	1/361 (0.28%)
Ascites ^* 1	1/346 (0.29%)	1/361 (0.28%)
Leak, Gi - Rectum ^* 1	0/346 (0.00%)	1/361 (0.28%)
Dysphagia ^* 1	5/346 (1.45%)	7/361 (1.94%)
Distention ^* 1	15/346 (4.34%)	7/361 (1.94%)
Taste Alteration ^* 1	34/346 (9.83%)	38/361 (10.53%)
Incontinence, Anal ^* 1	3/346 (0.87%)	1/361 (0.28%)
Fistula, Gi - Abdomen Nos ^* 1	0/346 (0.00%)	1/361 (0.28%)
Dry Mouth ^* 1	10/346 (2.89%)	9/361 (2.49%)
Mucositis (Functional/Sympt) - Rectum ^* 1	2/346 (0.58%)	0/361 (0.00%)
Mucositis (Functional/Sympt) - Oral Cavity ^* 1	14/346 (4.05%)	17/361 (4.71%)
Colitis ^* 1	0/346 (0.00%)	2/361 (0.55%)
Mucositis (Clinical Exam) - Rectum ^* 1	1/346 (0.29%)	0/361 (0.00%)
Mucositis (Functional/Sympt) - Anus ^* 1	1/346 (0.29%)	0/361 (0.00%)
Dentures ^* 1	1/346 (0.29%)	0/361 (0.00%)
Mucositis (Clinical Exam) - Oral Cavity ^* 1	14/346 (4.05%)	18/361 (4.99%)
Vomiting ^* 1	104/346 (30.06%)	76/361 (21.05%)
Anorexia ^* 1	121/346 (34.97%)	84/361 (23.27%)
Dehydration ^* 1	29/346 (8.38%)	11/361 (3.05%)
Constipation ^* 1	139/346 (40.17%)	173/361 (47.92%)
Nausea ^* 1	235/346 (67.92%)	183/361 (50.69%)
Gastrointestinal - Other ^* 1	13/346 (3.76%)	5/361 (1.39%)
Diarrhea ^* 1	253/346 (73.12%)	95/361 (26.32%)
Mucositis (Clinical Exam) - Pharynx ^* 1	0/346 (0.00%)	1/361 (0.28%)
General disorders
Constitutional Symptoms - Other ^* 1	11/346 (3.18%)	13/361 (3.60%)
Sweating ^* 1	10/346 (2.89%)	8/361 (2.22%)
Weight Gain ^* 1	6/346 (1.73%)	15/361 (4.16%)
Fever ^* 1	28/346 (8.09%)	14/361 (3.88%)
Weight Loss ^* 1	41/346 (11.85%)	12/361 (3.32%)
Obesity ^* 1	1/346 (0.29%)	0/361 (0.00%)
Rigors/Chills ^* 1	16/346 (4.62%)	15/361 (4.16%)
Fatigue ^* 1	294/346 (84.97%)	271/361 (75.07%)
Insomnia ^* 1	56/346 (16.18%)	63/361 (17.45%)
Pain - Other ^* 1	24/346 (6.94%)	18/361 (4.99%)
Pain: Urethra ^* 1	15/346 (4.34%)	2/361 (0.55%)
Pain: Perineum ^* 1	4/346 (1.16%)	0/361 (0.00%)
Pain: Pelvis ^* 1	8/346 (2.31%)	11/361 (3.05%)
Pain: Breast ^* 1	0/346 (0.00%)	1/361 (0.28%)
Pain: Vagina ^* 1	8/346 (2.31%)	2/361 (0.55%)
Pain: Chest /Thorax Nos ^* 1	10/346 (2.89%)	7/361 (1.94%)
Pain: Chest Wall ^* 1	3/346 (0.87%)	2/361 (0.55%)
Pain: Throat/Pharynx/Larynx ^* 1	5/346 (1.45%)	6/361 (1.66%)
Pain: Larynx ^* 1	1/346 (0.29%)	1/361 (0.28%)
Pain: Eye ^* 1	2/346 (0.58%)	0/361 (0.00%)
Pain: Head/Headache ^* 1	42/346 (12.14%)	56/361 (15.51%)
Pain: Neck ^* 1	2/346 (0.58%)	1/361 (0.28%)
Pain: Intestine ^* 1	2/346 (0.58%)	0/361 (0.00%)
Pain: Extremity-Limb ^* 1	48/346 (13.87%)	63/361 (17.45%)
Pain: Buttock ^* 1	3/346 (0.87%)	1/361 (0.28%)
Pain: Back ^* 1	25/346 (7.23%)	34/361 (9.42%)
Pain: Joint ^* 1	76/346 (21.97%)	102/361 (28.25%)
Pain: Bone ^* 1	68/346 (19.65%)	40/361 (11.08%)
Pain: Gallbladder ^* 1	1/346 (0.29%)	0/361 (0.00%)
Pain: Kidney ^* 1	1/346 (0.29%)	0/361 (0.00%)
Pain: Bladder ^* 1	16/346 (4.62%)	3/361 (0.83%)
Pain: Pain Nos ^* 1	9/346 (2.60%)	8/361 (2.22%)
Pain: Stomach ^* 1	2/346 (0.58%)	2/361 (0.55%)
Pain: Rectum ^* 1	5/346 (1.45%)	0/361 (0.00%)
Pain: Peritoneum ^* 1	1/346 (0.29%)	0/361 (0.00%)
Pain: Oral Cavity ^* 1	3/346 (0.87%)	2/361 (0.55%)
Pain: Esophagus ^* 1	2/346 (0.58%)	0/361 (0.00%)
Pain: Dental/Teeth/Peridontal ^* 1	3/346 (0.87%)	2/361 (0.55%)
Pain: Abdominal Pain Nos ^* 1	79/346 (22.83%)	53/361 (14.68%)
Pain: Scalp ^* 1	2/346 (0.58%)	5/361 (1.39%)
Pain: Oral - Gums ^* 1	0/346 (0.00%)	4/361 (1.11%)
Pain: Skin ^* 1	3/346 (0.87%)	0/361 (0.00%)
Pain: Middle Ear ^* 1	0/346 (0.00%)	1/361 (0.28%)
Pain: Cardiac/ Heart ^* 1	0/346 (0.00%)	2/361 (0.55%)
Pain: Muscle ^* 1	67/346 (19.36%)	82/361 (22.71%)
Pain: Anus ^* 1	3/346 (0.87%)	0/361 (0.00%)
Pain: Neuralgia ^* 1	2/346 (0.58%)	2/361 (0.55%)
Pain: Sinus ^* 1	1/346 (0.29%)	1/361 (0.28%)
Syndromes - Other ^* 1	1/346 (0.29%)	1/361 (0.28%)
Cytokine Release Syndrome ^* 1	0/346 (0.00%)	1/361 (0.28%)
Flu-Like Syndrome ^* 1	1/346 (0.29%)	8/361 (2.22%)
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other ^* 1	1/346 (0.29%)	0/361 (0.00%)
Cholecystitis ^* 1	0/346 (0.00%)	1/361 (0.28%)
Immune system disorders
Allergy/Immunology - Other ^* 1	3/346 (0.87%)	2/361 (0.55%)
Allergic Reaction/Hypersensitivity ^* 1	15/346 (4.34%)	28/361 (7.76%)
Rhinitis ^* 1	7/346 (2.02%)	15/361 (4.16%)
Autoimmune Reaction ^* 1	0/346 (0.00%)	1/361 (0.28%)
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Wound ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf W/Gr 3 Or 4 Anc: Blood ^* 1	0/346 (0.00%)	3/361 (0.83%)
Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis) ^* 1	0/346 (0.00%)	2/361 (0.55%)
Inf W/Nml Or Gr 1 Or 2 Anc: Vulva ^* 1	2/346 (0.58%)	2/361 (0.55%)
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos ^* 1	2/346 (0.58%)	2/361 (0.55%)
Inf W/Nml Or Gr 1 Or 2 Anc: Neck Nos ^* 1	1/346 (0.29%)	0/361 (0.00%)
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf W/Nml Or Gr 1 Or 2 Anc: Eye Nos ^* 1	1/346 (0.29%)	0/361 (0.00%)
Inf W/Nml Or Gr 1 Or 2 Anc: Blood ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums ^* 1	0/346 (0.00%)	2/361 (0.55%)
Inf W/Nml Or Gr 1 Or 2 Anc: Otitis Media Nos ^* 1	1/346 (0.29%)	0/361 (0.00%)
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) ^* 1	6/346 (1.73%)	5/361 (1.39%)
Febrile Neutropenia ^* 1	3/346 (0.87%)	2/361 (0.55%)
Inf W/Nml Or Gr 1 Or 2 Anc: Lip/Perioral ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf W/Nml Or Gr 1 Or 2 Anc: Rectum ^* 1	1/346 (0.29%)	0/361 (0.00%)
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth ^* 1	1/346 (0.29%)	0/361 (0.00%)
Inf W/Nml Or Gr 1 Or 2 Anc: Colon ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos ^* 1	19/346 (5.49%)	14/361 (3.88%)
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf W/Nml Or Gr 1 Or 2 Anc: Ungual (Nails) ^* 1	1/346 (0.29%)	0/361 (0.00%)
Inf Unknown Anc: Blood ^* 1	1/346 (0.29%)	0/361 (0.00%)
Infection - Other ^* 1	16/346 (4.62%)	9/361 (2.49%)
Opportunisitic Inf Assoc. W/Gr 2 Lymphopenia ^* 1	2/346 (0.58%)	1/361 (0.28%)
Colitis, Infectious (Eg.C. Difficile) ^* 1	2/346 (0.58%)	0/361 (0.00%)
Inf W/Gr 3 Or 4 Anc: Oral Cavity-Gums ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf W/Nml Or Gr 1 Or 2 Anc: Conjunctiva ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf Unknown Anc: Vulva ^* 1	1/346 (0.29%)	1/361 (0.28%)
Inf Unknown Anc: Vagina ^* 1	2/346 (0.58%)	2/361 (0.55%)
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus ^* 1	1/346 (0.29%)	1/361 (0.28%)
Inf W/Nml Or Gr 1 Or 2 Anc: Mucosa ^* 1	1/346 (0.29%)	0/361 (0.00%)
Inf Unknown Anc: Upper Airway Nos ^* 1	3/346 (0.87%)	5/361 (1.39%)
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina ^* 1	2/346 (0.58%)	3/361 (0.83%)
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus ^* 1	1/346 (0.29%)	5/361 (1.39%)
Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos ^* 1	1/346 (0.29%)	0/361 (0.00%)
Inf Unknown Anc: Bronchus ^* 1	1/346 (0.29%)	0/361 (0.00%)
Inf Unknown Anc: Soft Tissue Nos ^* 1	1/346 (0.29%)	0/361 (0.00%)
Inf W/Nml Or Gr 1 Or 2 Anc:peritoneal Cavity ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf Unknown Anc: Urinary Tract Nos ^* 1	13/346 (3.76%)	12/361 (3.32%)
Inf Unknown Anc: Urethra ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf Unknown Anc: Kidney ^* 1	1/346 (0.29%)	0/361 (0.00%)
Inf Unknown Anc: Bladder (Urinary) ^* 1	1/346 (0.29%)	1/361 (0.28%)
Inf Unknown Anc: Catheter-Related ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf Unknown Anc: Abdomen Nos ^* 1	1/346 (0.29%)	0/361 (0.00%)
Inf Unknown Anc: Skin (Cellulitis) ^* 1	1/346 (0.29%)	0/361 (0.00%)
Inf W/Gr 3 Or 4 Anc: Sinus ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia) ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf W/Gr 3 Or 4 Anc: Joint ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf W/Gr 3 Or 4 Anc: Lymphatic ^* 1	0/346 (0.00%)	1/361 (0.28%)
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder ^* 1	3/346 (0.87%)	3/361 (0.83%)
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos ^* 1	0/346 (0.00%)	4/361 (1.11%)
Inf W/Gr 3 Or 4 Anc: Urethra ^* 1	0/346 (0.00%)	1/361 (0.28%)
Metabolism and nutrition disorders
Ast ^* 1	23/346 (6.65%)	34/361 (9.42%)
Gfr ^* 1	4/346 (1.16%)	4/361 (1.11%)
Metabolic/Laboratory - Other ^* 1	8/346 (2.31%)	9/361 (2.49%)
Alkalosis ^* 1	0/346 (0.00%)	1/361 (0.28%)
Cholesterol,serum High ^* 1	0/346 (0.00%)	2/361 (0.55%)
Proteinuria ^* 1	5/346 (1.45%)	1/361 (0.28%)
Hemoglobinuria ^* 1	2/346 (0.58%)	0/361 (0.00%)
Creatinine ^* 1	39/346 (11.27%)	24/361 (6.65%)
Hypoalbuminemia ^* 1	29/346 (8.38%)	33/361 (9.14%)
Ggt ^* 1	2/346 (0.58%)	0/361 (0.00%)
Alt ^* 1	28/346 (8.09%)	33/361 (9.14%)
Alkaline Phosphatase ^* 1	40/346 (11.56%)	35/361 (9.70%)
Bilirubin ^* 1	5/346 (1.45%)	5/361 (1.39%)
Lipase ^* 1	0/346 (0.00%)	1/361 (0.28%)
Hypermagnesemia ^* 1	5/346 (1.45%)	3/361 (0.83%)
Hypophosphatemia ^* 1	5/346 (1.45%)	2/361 (0.55%)
Hyponatremia ^* 1	39/346 (11.27%)	31/361 (8.59%)
Hyperuricemia ^* 1	1/346 (0.29%)	4/361 (1.11%)
Hypertriglyceridemia ^* 1	1/346 (0.29%)	2/361 (0.55%)
Bicarbonate, Serum-Low ^* 1	3/346 (0.87%)	0/361 (0.00%)
Hypernatremia ^* 1	7/346 (2.02%)	2/361 (0.55%)
Hypocalcemia ^* 1	35/346 (10.12%)	20/361 (5.54%)
Hyperkalemia ^* 1	14/346 (4.05%)	7/361 (1.94%)
Hyperglycemia ^* 1	78/346 (22.54%)	73/361 (20.22%)
Hypokalemia ^* 1	50/346 (14.45%)	44/361 (12.19%)
Hypoglycemia ^* 1	6/346 (1.73%)	2/361 (0.55%)
Hypercalcemia ^* 1	6/346 (1.73%)	11/361 (3.05%)
Hypomagnesemia ^* 1	70/346 (20.23%)	53/361 (14.68%)
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other ^* 1	8/346 (2.31%)	10/361 (2.77%)
Lumbar Spine Rom ^* 1	1/346 (0.29%)	0/361 (0.00%)
Joint-Function ^* 1	0/346 (0.00%)	3/361 (0.83%)
Fracture ^* 1	2/346 (0.58%)	0/361 (0.00%)
Gait/Walking ^* 1	2/346 (0.58%)	0/361 (0.00%)
Arthritis ^* 1	6/346 (1.73%)	8/361 (2.22%)
Muscle Weakness - Whole Body/Generalized ^* 1	36/346 (10.40%)	19/361 (5.26%)
Muscle Weakness - Right-Sided ^* 1	1/346 (0.29%)	0/361 (0.00%)
Muscle Weakness - Extremity-Upper ^* 1	1/346 (0.29%)	0/361 (0.00%)
Muscle Weakness - Extremity-Lower ^* 1	18/346 (5.20%)	11/361 (3.05%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
2nd Mal: Poss. Related To Cancer Rx ^* 1	0/346 (0.00%)	1/361 (0.28%)
Nervous system disorders
Syncope ^* 1	2/346 (0.58%)	3/361 (0.83%)
Involuntary Movement ^* 1	3/346 (0.87%)	3/361 (0.83%)
Psychosis ^* 1	0/346 (0.00%)	2/361 (0.55%)
Neurology - Other ^* 1	8/346 (2.31%)	9/361 (2.49%)
Mental Status ^* 1	0/346 (0.00%)	2/361 (0.55%)
Encephalopathy ^* 1	0/346 (0.00%)	1/361 (0.28%)
Mood Alteration - Euphoria ^* 1	0/346 (0.00%)	2/361 (0.55%)
Mood Alteration - Depression ^* 1	35/346 (10.12%)	37/361 (10.25%)
Mood Alteration - Anxiety ^* 1	35/346 (10.12%)	41/361 (11.36%)
Mood Alteration - Agitation ^* 1	1/346 (0.29%)	7/361 (1.94%)
Tremor ^* 1	5/346 (1.45%)	5/361 (1.39%)
Speech Impairment ^* 1	1/346 (0.29%)	2/361 (0.55%)
Seizure ^* 1	2/346 (0.58%)	1/361 (0.28%)
Personality ^* 1	1/346 (0.29%)	0/361 (0.00%)
Irritability ^* 1	0/346 (0.00%)	1/361 (0.28%)
Cognitive Disturbance ^* 1	3/346 (0.87%)	6/361 (1.66%)
Ataxia ^* 1	3/346 (0.87%)	2/361 (0.55%)
Confusion ^* 1	4/346 (1.16%)	4/361 (1.11%)
Memory Impairment ^* 1	10/346 (2.89%)	12/361 (3.32%)
Dizziness ^* 1	40/346 (11.56%)	57/361 (15.79%)
Neuropathy,cranial - Cn Viii Hearing/Balance ^* 1	1/346 (0.29%)	0/361 (0.00%)
Neuropathy,cranial - Cn I Smell ^* 1	1/346 (0.29%)	0/361 (0.00%)
Neuropathy-Sensory ^* 1	230/346 (66.47%)	253/361 (70.08%)
Neuropathy-Motor ^* 1	11/346 (3.18%)	21/361 (5.82%)
Renal and urinary disorders
Renal/Genitourinary - Other ^* 1	19/346 (5.49%)	5/361 (1.39%)
Leak, Gu - Vagina ^* 1	0/346 (0.00%)	1/361 (0.28%)
Cystitis ^* 1	19/346 (5.49%)	4/361 (1.11%)
Urinary Color Change ^* 1	1/346 (0.29%)	0/361 (0.00%)
Urinary Retention ^* 1	6/346 (1.73%)	4/361 (1.11%)
Obstruction, Gu - Ureter ^* 1	2/346 (0.58%)	1/361 (0.28%)
Obstruction, Gu - Stoma ^* 1	1/346 (0.29%)	0/361 (0.00%)
Obstruction, Gu - Bladder ^* 1	0/346 (0.00%)	1/361 (0.28%)
Incontinence, Urinary ^* 1	35/346 (10.12%)	14/361 (3.88%)
Bladder Spasm ^* 1	0/346 (0.00%)	1/361 (0.28%)
Renal Failure ^* 1	1/346 (0.29%)	0/361 (0.00%)
Urinary Frequency ^* 1	61/346 (17.63%)	21/361 (5.82%)
Reproductive system and breast disorders
Breast ^* 1	2/346 (0.58%)	0/361 (0.00%)
Vaginal Dryness ^* 1	4/346 (1.16%)	2/361 (0.55%)
Sexual/Reproductive Function: Other ^* 1	3/346 (0.87%)	4/361 (1.11%)
Vaginitis ^* 1	2/346 (0.58%)	1/361 (0.28%)
Vaginal Stenosis ^* 1	4/346 (1.16%)	0/361 (0.00%)
Vaginal Mucositis ^* 1	5/346 (1.45%)	0/361 (0.00%)
Vaginal Discharge ^* 1	12/346 (3.47%)	7/361 (1.94%)
Orgasmic Function ^* 1	0/346 (0.00%)	1/361 (0.28%)
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other ^* 1	7/346 (2.02%)	3/361 (0.83%)
Nasal/Paranasal Reactions ^* 1	6/346 (1.73%)	7/361 (1.94%)
Edema, Larynx ^* 1	1/346 (0.29%)	0/361 (0.00%)
Bronchospasm ^* 1	0/346 (0.00%)	2/361 (0.55%)
Voice Changes ^* 1	1/346 (0.29%)	0/361 (0.00%)
Hypoxia ^* 1	2/346 (0.58%)	0/361 (0.00%)
Hiccoughs ^* 1	1/346 (0.29%)	0/361 (0.00%)
Cough ^* 1	36/346 (10.40%)	45/361 (12.47%)
Pleural Effusion ^* 1	1/346 (0.29%)	0/361 (0.00%)
Dyspnea ^* 1	76/346 (21.97%)	65/361 (18.01%)
Skin and subcutaneous tissue disorders
Nail Changes ^* 1	9/346 (2.60%)	14/361 (3.88%)
Photosensitivity ^* 1	0/346 (0.00%)	1/361 (0.28%)
Injection Site Reaction ^* 1	3/346 (0.87%)	1/361 (0.28%)
Hair Loss/Alopecia (Scalp Or Body) ^* 1	208/346 (60.12%)	258/361 (71.47%)
Erythema Multiforme ^* 1	2/346 (0.58%)	3/361 (0.83%)
Dermatitis - Chemoradiation ^* 1	3/346 (0.87%)	0/361 (0.00%)
Hypopigmentation ^* 1	1/346 (0.29%)	1/361 (0.28%)
Cheilitis ^* 1	0/346 (0.00%)	1/361 (0.28%)
Wound Complication, Non-Infectious ^* 1	1/346 (0.29%)	2/361 (0.55%)
Bruising ^* 1	8/346 (2.31%)	5/361 (1.39%)
Acne ^* 1	3/346 (0.87%)	3/361 (0.83%)
Rash ^* 1	48/346 (13.87%)	44/361 (12.19%)
Dry Skin ^* 1	9/346 (2.60%)	13/361 (3.60%)
Dermatitis - Radiation ^* 1	17/346 (4.91%)	0/361 (0.00%)
Telangiectasia ^* 1	0/346 (0.00%)	1/361 (0.28%)
Pruritus ^* 1	15/346 (4.34%)	19/361 (5.26%)
Burn ^* 1	2/346 (0.58%)	0/361 (0.00%)
Urticaria ^* 1	1/346 (0.29%)	4/361 (1.11%)
Flushing ^* 1	11/346 (3.18%)	10/361 (2.77%)
Hand-Foot ^* 1	0/346 (0.00%)	2/361 (0.55%)
Dermatology/Skin - Other ^* 1	18/346 (5.20%)	14/361 (3.88%)
Hyperpigmentation ^* 1	3/346 (0.87%)	5/361 (1.39%)
Ulceration ^* 1	5/346 (1.45%)	1/361 (0.28%)
Surgical and medical procedures
Intra-Op Injury: Urinary Tract Nos ^* 1	1/346 (0.29%)	0/361 (0.00%)
Intra-Op Injury: Other ^* 1	1/346 (0.29%)	0/361 (0.00%)
Vascular disorders
Inr ^* 1	1/346 (0.29%)	6/361 (1.66%)
Coagulopathy - Other ^* 1	0/346 (0.00%)	1/361 (0.28%)
Ptt ^* 1	0/346 (0.00%)	3/361 (0.83%)
Hemorrhage, Gu - Urinary Nos ^* 1	5/346 (1.45%)	2/361 (0.55%)
Hemorrhage, Gu - Vagina ^* 1	6/346 (1.73%)	6/361 (1.66%)
Hemorrhage, Gi - Rectum ^* 1	7/346 (2.02%)	6/361 (1.66%)
Hemorrhage/Pulmonary - Nose ^* 1	6/346 (1.73%)	5/361 (1.39%)
Hematoma ^* 1	0/346 (0.00%)	1/361 (0.28%)
Hemorrhage, Gi - Lower Gi Nos ^* 1	1/346 (0.29%)	0/361 (0.00%)
Hemorrhage, Gi - Oral Cavity ^* 1	1/346 (0.29%)	1/361 (0.28%)
Hemorrhage, Gu - Bladder ^* 1	1/346 (0.29%)	1/361 (0.28%)
Hemorrhage, Gi - Colon ^* 1	0/346 (0.00%)	1/361 (0.28%)
Hemorrhage, Cns ^* 1	1/346 (0.29%)	0/361 (0.00%)
Petechiae ^* 1	1/346 (0.29%)	0/361 (0.00%)
Hemorrhage/Bleeding - Other ^* 1	0/346 (0.00%)	1/361 (0.28%)
Vascular - Other ^* 1	2/346 (0.58%)	0/361 (0.00%)
Portal Flow ^* 1	1/346 (0.29%)	0/361 (0.00%)
Artery Injury - Visceral ^* 1	0/346 (0.00%)	1/361 (0.28%)
Thrombosis/Embolism (Vascular Access-Related) ^* 1	0/346 (0.00%)	1/361 (0.28%)
Thrombosis/Thrombus/Embolism ^* 1	6/346 (1.73%)	9/361 (2.49%)
Phlebitis ^* 1	1/346 (0.29%)	1/361 (0.28%)
1 Term from vocabulary, CTCAE (3.0) * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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:	Linda Gedeon on behalf of Virginia Filiaci, PhD. and Helen Huang, MS.
Organization:	NRG Oncology
Phone:	716-845-1169
EMail:	lgedeon@gogstats.org

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

Matulonis UA, Huang HQ, Filiaci VL, Randall M, DiSilvestro PA, Moxley KM, Fowler JM, Powell MA, Spirtos NM, Tewari KS, Richards WE, Nakayama JM, Mutch DG, Miller DS, Matei D, Wenzel LB. Patient reported outcomes for cisplatin and radiation followed by carboplatin/paclitaxel versus carboplatin/paclitaxel for locally advanced endometrial carcinoma: An NRG oncology study. Gynecol Oncol. 2022 Feb;164(2):428-436. doi: 10.1016/j.ygyno.2021.11.021. Epub 2021 Dec 11.

Matei D, Filiaci V, Randall ME, Mutch D, Steinhoff MM, DiSilvestro PA, Moxley KM, Kim YM, Powell MA, O'Malley DM, Spirtos NM, Small W Jr, Tewari KS, Richards WE, Nakayama J, Matulonis UA, Huang HQ, Miller DS. Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer. N Engl J Med. 2019 Jun 13;380(24):2317-2326. doi: 10.1056/NEJMoa1813181.

Layout table for additonal information

Responsible Party:	GOG Foundation ( Gynecologic Oncology Group )
ClinicalTrials.gov Identifier:	NCT00942357
Other Study ID Numbers:	GOG-0258 NCI-2011-01951 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 10-00685 CDR0000649079 GOG-0258 ( Other Identifier: NRG Oncology ) GOG-0258 ( Other Identifier: CTEP ) U10CA180868 ( U.S. NIH Grant/Contract ) U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted:	July 17, 2009
First Posted:	July 20, 2009
Results First Submitted:	August 23, 2018
Results First Posted:	December 19, 2018
Last Update Posted:	October 19, 2021

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