Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

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ClinicalTrials.gov Identifier: NCT01167712

Recruitment Status : Active, not recruiting

First Posted : July 22, 2010

Results First Posted : January 23, 2018

Last Update Posted : May 16, 2024

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Sponsor:

Collaborator:

NRG Oncology

Information provided by (Responsible Party):

National Cancer Institute (NCI)

Study Type	Interventional
Study Design	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Fallopian Tube Endometrioid Adenocarcinoma Fallopian Tube Mucinous Adenocarcinoma Fallopian Tube Transitional Cell Carcinoma Ovarian Brenner Tumor Ovarian Clear Cell Adenocarcinofibroma Ovarian Endometrioid Adenocarcinoma Ovarian Mucinous Adenocarcinoma Ovarian Seromucinous Carcinoma Ovarian Serous Adenocarcinoma Ovarian Transitional Cell Carcinoma Ovarian Undifferentiated Carcinoma Primary Peritoneal Serous Adenocarcinoma Stage IIA Fallopian Tube Cancer AJCC v6 and v7 Stage IIA Ovarian Cancer AJCC V6 and v7 Stage IIB Fallopian Tube Cancer AJCC v6 and v7 Stage IIB Ovarian Cancer AJCC v6 and v7 Stage IIC Fallopian Tube Cancer AJCC v6 and v7 Stage IIC Ovarian Cancer AJCC v6 and v7 Stage IIIA Fallopian Tube Cancer AJCC v7 Stage IIIA Ovarian Cancer AJCC v6 and v7 Stage IIIA Primary Peritoneal Cancer AJCC v7 Stage IIIB Fallopian Tube Cancer AJCC v7 Stage IIIB Ovarian Cancer AJCC v6 and v7 Stage IIIB Primary Peritoneal Cancer AJCC v7 Stage IIIC Fallopian Tube Cancer AJCC v7 Stage IIIC Ovarian Cancer AJCC v6 and v7 Stage IIIC Primary Peritoneal Cancer AJCC v7 Stage IV Fallopian Tube Cancer AJCC v6 and v7 Stage IV Ovarian Cancer AJCC v6 and v7 Stage IV Primary Peritoneal Cancer AJCC v7
Interventions	Biological: Bevacizumab Drug: Carboplatin Procedure: Computed Tomography Drug: Paclitaxel Procedure: Therapeutic Conventional Surgery
Enrollment	692

Participant Flow

Recruitment Details	Newly diagnosed women with high-risk early stage or advanced stage epithelial ovarian cancer enrolled from September 27, 2010 to February 8, 2012.These women were randomly assigned to receive either carboplatin (AUC 6) combined with either paclitaxel 175 mg/m2 q 21 days or paclitaxel 80mg/m2 on days 1, 8 and 15. Bevacizumab was optional.
Pre-assignment Details	112 additional women, whose treatment was not randomized, enrolled onto this study in order to evaluate whether findings from perfusion imaging are prognostic. This report focuses on the randomized treatment component of this study.


Arm/Group Title	Arm I (Adjuvant Chemotherapy Suboptimally Debulked)	Arm II (Neoadjuvant Chemotherapy)
Arm/Group Description	Patients receive paclitaxel IV over...	Patients receive paclitaxel IV over...
Arm/Group Description	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV	Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Period Title: Overall Study
Started	346	346
Completed	346	346
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Arm I (Adjuvant Chemotherapy Suboptimally Debulked)	Arm II (Neoadjuvant Chemotherapy)	Total
Arm/Group Description		Patients receive paclitaxel IV over...	Patients receive paclitaxel IV over...	Total of all reporting groups
Arm/Group Description		Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery	Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery	Total of all reporting groups
Overall Number of Baseline Participants		346	346	692
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Newly diagnosed women with high-risk early stage or advanced stage epithelial ovarian cancer.
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	346 participants	346 participants	692 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	214 61.8%	217 62.7%	431 62.3%
	>=65 years	132 38.2%	129 37.3%	261 37.7%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	346 participants	346 participants	692 participants
	Female	346 100.0%	346 100.0%	692 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	346 participants	346 participants	692 participants
Canada		1	0	1
United States		345	345	690
South Korea		0	1	1

Outcome Measures

1.Primary Outcome


Title	Progression-Free Survival
Description	First progression or death for weekly paclitaxel treatment relative to...
Description	First progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel. 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	The timeframe is from enrollment onto the study up to 3 years following enrollment.

Outcome Measure Data

Analysis Population Description

Whole sample


Arm/Group Title	Arm I (Adjuvant Chemotherapy Suboptimally Debulked)	Arm II (Neoadjuvant Chemotherapy)
Arm/Group Description:	Patients receive paclitaxel IV over...	Patients receive paclitaxel IV over...
Arm/Group Description:	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV	Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Overall Number of Participants Analyzed	346	346
Median (95% Confidence Interval) Unit of Measure: months
	14.7 (13.5 to 15.8)	14.0 (12.7 to 15.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Adjuvant Chemotherapy Suboptimally Debulked), Arm II (Neoadjuvant Chemotherapy)
	Comments	Estimated hazard of first progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	.89
	Confidence Interval	(2-Sided) 95% .74 to 1.06
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Median Duration of First Quartile Survival
Description	First Quartile Overall Survival
Description	First Quartile Overall Survival
Time Frame	The timeframe is from enrollment onto the study up to 3 years after enrollment

Outcome Measure Data

Analysis Population Description

Whole sample


Arm/Group Title	Arm I (Adjuvant Chemotherapy Suboptimally Debulked)	Arm II (Neoadjuvant Chemotherapy)
Arm/Group Description:	Patients receive paclitaxel IV over...	Patients receive paclitaxel IV over...
Arm/Group Description:	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV	Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Overall Number of Participants Analyzed	346	346
Median (95% Confidence Interval) Unit of Measure: months
	23.2 (20.1 to 26.3)	24 (19.8 to 26.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Adjuvant Chemotherapy Suboptimally Debulked), Arm II (Neoadjuvant Chemotherapy)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	.94
	Confidence Interval	(2-Sided) 95% .72 to 1.23
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Quality of Life Score as Measured by Functional Assessment of Cancer Therapy-Ovary-Total Outcome Index (Fact-O TOI)
Description	Mean quality of life score after 6 cycles of study treatment estimated...
Description	Mean quality of life score after 6 cycles of study treatment estimated from a mixed model. The FACT-O-TOI is composed of three subscales: Physical Well Being (PWB) (7 Items), Functional Well Being (FWB) (7 items), and Ovarian Cancer Subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). A subscale score is computed as long as more than 50% of subscale items have been answered. A Total score of the FACT-O TOI is the summation of the three subscale scores; if more than 80% of the FACT-O TOI items provide valid responses and all three subscales have valid scores. A score of the FACT-O TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL)
Time Frame	18 weeks after enrolling on the study, which is the time it takes to complete 6 cycles of treatment plus 3 weeks

Outcome Measure Data

Analysis Population Description

All individuals who did not opt for neo-adjuvant treatment and completed a baseline FACT-O TOI assessment and at least one follow-up assessment.


Arm/Group Title	Arm I (Adjuvant Chemotherapy Suboptimally Debulked)	Arm II (Neoadjuvant Chemotherapy)
Arm/Group Description:	Patients receive paclitaxel IV over...	Patients receive paclitaxel IV over...
Arm/Group Description:	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV	Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Overall Number of Participants Analyzed	292	287
Mean (Standard Error) Unit of Measure: Units on a Scale
	70.9 (1.42)	68.2 (1.59)

4.Other Pre-specified Outcome


Title	Changes in the Tumor Perfusion Parameters as Quantified by Vascularity or Blood Volume; Perfusion or Blood Flow; Mean Transit Time; and Microvascular Permeability or Permeability Surface Area Product
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline (T0) up to 10 days after the start of course 2 (T2)

Outcome Measure Data Not Reported

Adverse Events

Time Frame	AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Arm I (Adjuvant Chemotherapy Suboptimally Debulked)	Arm II (Neoadjuvant Chemotherapy)
Arm/Group Description	Patients receive paclitaxel IV over...	Patients receive paclitaxel IV over...
Arm/Group Description	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV	Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
All-Cause Mortality
	Arm I (Adjuvant Chemotherapy Suboptimally Debulked)	Arm II (Neoadjuvant Chemotherapy)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Arm I (Adjuvant Chemotherapy Suboptimally Debulked)	Arm II (Neoadjuvant Chemotherapy)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	122/346 (35.26%)	167/346 (48.27%)
Blood and lymphatic system disorders
Hemolytic Uremic Syndrome ^* 1	0/346 (0.00%)	1/346 (0.29%)
Anemia ^* 1	1/346 (0.29%)	1/346 (0.29%)
Febrile Neutropenia ^* 1	10/346 (2.89%)	8/346 (2.31%)
Cardiac disorders
Atrial Fibrillation ^* 1	1/346 (0.29%)	1/346 (0.29%)
Cardiac Arrest ^* 1	1/346 (0.29%)	0/346 (0.00%)
Myocardial Infarction ^* 1	1/346 (0.29%)	0/346 (0.00%)
Left Ventricular Systolic Dysfunction ^* 1	1/346 (0.29%)	0/346 (0.00%)
Acute Coronary Syndrome ^* 1	2/346 (0.58%)	0/346 (0.00%)
Ventricular Fibrillation ^* 1	0/346 (0.00%)	1/346 (0.29%)
Ventricular Arrhythmia ^* 1	1/346 (0.29%)	0/346 (0.00%)
Paroxysmal Atrial Tachycardia ^* 1	0/346 (0.00%)	1/346 (0.29%)
Eye disorders
Dry Eye ^* 1	1/346 (0.29%)	0/346 (0.00%)
Retinal Detachment ^* 1	1/346 (0.29%)	0/346 (0.00%)
Gastrointestinal disorders
Colonic Obstruction ^* 1	1/346 (0.29%)	1/346 (0.29%)
Colonic Perforation ^* 1	0/346 (0.00%)	2/346 (0.58%)
Colonic Fistula ^* 1	1/346 (0.29%)	1/346 (0.29%)
Colitis ^* 1	3/346 (0.87%)	0/346 (0.00%)
Constipation ^* 1	2/346 (0.58%)	1/346 (0.29%)
Diarrhea ^* 1	4/346 (1.16%)	5/346 (1.45%)
Duodenal Perforation ^* 1	0/346 (0.00%)	1/346 (0.29%)
Vomiting ^* 1	5/346 (1.45%)	7/346 (2.02%)
Small Intestinal Obstruction ^* 1	8/346 (2.31%)	13/346 (3.76%)
Abdominal Pain ^* 1	6/346 (1.73%)	7/346 (2.02%)
Rectal Hemorrhage ^* 1	0/346 (0.00%)	1/346 (0.29%)
Obstruction Gastric ^* 1	1/346 (0.29%)	2/346 (0.58%)
Lower Gastrointestinal Hemorrhage ^* 1	0/346 (0.00%)	1/346 (0.29%)
Gastrointestinal Disorders - Other ^* 1	0/346 (0.00%)	2/346 (0.58%)
Ileal Perforation ^* 1	1/346 (0.29%)	1/346 (0.29%)
Ileal Obstruction ^* 1	1/346 (0.29%)	0/346 (0.00%)
Ileal Fistula ^* 1	1/346 (0.29%)	0/346 (0.00%)
Retroperitoneal Hemorrhage ^* 1	0/346 (0.00%)	1/346 (0.29%)
Gastric Hemorrhage ^* 1	0/346 (0.00%)	1/346 (0.29%)
Nausea ^* 1	0/346 (0.00%)	4/346 (1.16%)
Pancreatitis ^* 1	0/346 (0.00%)	1/346 (0.29%)
Gastrointestinal Fistula ^* 1	0/346 (0.00%)	1/346 (0.29%)
Gastric Ulcer ^* 1	1/346 (0.29%)	0/346 (0.00%)
Rectal Pain ^* 1	1/346 (0.29%)	0/346 (0.00%)
Gastric Perforation ^* 1	0/346 (0.00%)	1/346 (0.29%)
Gastric Fistula ^* 1	0/346 (0.00%)	1/346 (0.29%)
Esophageal Ulcer ^* 1	1/346 (0.29%)	0/346 (0.00%)
Esophagitis ^* 1	1/346 (0.29%)	0/346 (0.00%)
Jejunal Obstruction ^* 1	0/346 (0.00%)	1/346 (0.29%)
General disorders
Pain ^* 1	1/346 (0.29%)	1/346 (0.29%)
Multi-Organ Failure ^* 1	1/346 (0.29%)	0/346 (0.00%)
Malaise ^* 1	0/346 (0.00%)	1/346 (0.29%)
Non-Cardiac Chest Pain ^* 1	1/346 (0.29%)	0/346 (0.00%)
Fatigue ^* 1	0/346 (0.00%)	1/346 (0.29%)
Death Nos ^* 1	1/346 (0.29%)	1/346 (0.29%)
Fever ^* 1	1/346 (0.29%)	3/346 (0.87%)
Infusion Related Reaction ^* 1	0/346 (0.00%)	2/346 (0.58%)
Hepatobiliary disorders
Portal Vein Thrombosis ^* 1	1/346 (0.29%)	0/346 (0.00%)
Infections and infestations
Infections And Infestations - Other ^* 1	0/346 (0.00%)	1/346 (0.29%)
Wound Infection ^* 1	0/346 (0.00%)	1/346 (0.29%)
Tooth Infection ^* 1	0/346 (0.00%)	1/346 (0.29%)
Splenic Infection ^* 1	0/346 (0.00%)	1/346 (0.29%)
Skin Infection ^* 1	1/346 (0.29%)	0/346 (0.00%)
Sepsis ^* 1	4/346 (1.16%)	5/346 (1.45%)
Pleural Infection ^* 1	1/346 (0.29%)	0/346 (0.00%)
Pelvic Infection ^* 1	1/346 (0.29%)	3/346 (0.87%)
Lung Infection ^* 1	0/346 (0.00%)	2/346 (0.58%)
Kidney Infection ^* 1	0/346 (0.00%)	1/346 (0.29%)
Endocarditis Infective ^* 1	0/346 (0.00%)	1/346 (0.29%)
Device Related Infection ^* 1	0/346 (0.00%)	3/346 (0.87%)
Urinary Tract Infection ^* 1	0/346 (0.00%)	2/346 (0.58%)
Catheter Related Infection ^* 1	0/346 (0.00%)	5/346 (1.45%)
Enterocolitis Infectious ^* 1	1/346 (0.29%)	0/346 (0.00%)
Bladder Infection ^* 1	0/346 (0.00%)	1/346 (0.29%)
Anorectal Infection ^* 1	0/346 (0.00%)	1/346 (0.29%)
Abdominal Infection ^* 1	0/346 (0.00%)	1/346 (0.29%)
Injury, poisoning and procedural complications
Wound Dehiscence ^* 1	0/346 (0.00%)	4/346 (1.16%)
Seroma ^* 1	1/346 (0.29%)	0/346 (0.00%)
Stomal Ulcer ^* 1	0/346 (0.00%)	1/346 (0.29%)
Hip Fracture ^* 1	1/346 (0.29%)	0/346 (0.00%)
Fracture ^* 1	0/346 (0.00%)	2/346 (0.58%)
Wound Complication ^* 1	2/346 (0.58%)	0/346 (0.00%)
Investigations
Platelet Count Decreased ^* 1	0/346 (0.00%)	2/346 (0.58%)
Neutrophil Count Decreased ^* 1	7/346 (2.02%)	0/346 (0.00%)
Metabolism and nutrition disorders
Hyponatremia ^* 1	0/346 (0.00%)	1/346 (0.29%)
Hypomagnesemia ^* 1	1/346 (0.29%)	0/346 (0.00%)
Hypokalemia ^* 1	2/346 (0.58%)	1/346 (0.29%)
Dehydration ^* 1	4/346 (1.16%)	4/346 (1.16%)
Musculoskeletal and connective tissue disorders
Myalgia ^* 1	0/346 (0.00%)	1/346 (0.29%)
Joint Effusion ^* 1	1/346 (0.29%)	0/346 (0.00%)
Generalized Muscle Weakness ^* 1	0/346 (0.00%)	1/346 (0.29%)
Chest Wall Pain ^* 1	1/346 (0.29%)	0/346 (0.00%)
Bone Pain ^* 1	1/346 (0.29%)	0/346 (0.00%)
Back Pain ^* 1	0/346 (0.00%)	2/346 (0.58%)
Arthralgia ^* 1	0/346 (0.00%)	1/346 (0.29%)
Abdominal Soft Tissue Necrosis ^* 1	1/346 (0.29%)	0/346 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl ^* 1	1/346 (0.29%)	0/346 (0.00%)
Tumor Pain ^* 1	0/346 (0.00%)	1/346 (0.29%)
Nervous system disorders
Transient Ischemic Attacks ^* 1	0/346 (0.00%)	1/346 (0.29%)
Stroke ^* 1	2/346 (0.58%)	0/346 (0.00%)
Seizure ^* 1	0/346 (0.00%)	1/346 (0.29%)
Peripheral Sensory Neuropathy ^* 1	0/346 (0.00%)	2/346 (0.58%)
Peripheral Motor Neuropathy ^* 1	0/346 (0.00%)	1/346 (0.29%)
Intracranial Hemorrhage ^* 1	0/346 (0.00%)	1/346 (0.29%)
Headache ^* 1	1/346 (0.29%)	0/346 (0.00%)
Syncope ^* 1	1/346 (0.29%)	3/346 (0.87%)
Dizziness ^* 1	0/346 (0.00%)	1/346 (0.29%)
Psychiatric disorders
Depression ^* 1	0/346 (0.00%)	1/346 (0.29%)
Confusion ^* 1	0/346 (0.00%)	2/346 (0.58%)
Anxiety ^* 1	1/346 (0.29%)	0/346 (0.00%)
Renal and urinary disorders
Renal And Urinary Disorders - Other ^* 1	1/346 (0.29%)	0/346 (0.00%)
Urinary Tract Obstruction ^* 1	1/346 (0.29%)	0/346 (0.00%)
Urinary Fistula ^* 1	0/346 (0.00%)	1/346 (0.29%)
Renal Calculi ^* 1	1/346 (0.29%)	0/346 (0.00%)
Proteinuria ^* 1	0/346 (0.00%)	1/346 (0.29%)
Acute Kidney Injury ^* 1	1/346 (0.29%)	1/346 (0.29%)
Reproductive system and breast disorders
Vaginal Hemorrhage ^* 1	0/346 (0.00%)	1/346 (0.29%)
Vaginal Fistula ^* 1	0/346 (0.00%)	1/346 (0.29%)
Respiratory, thoracic and mediastinal disorders
Respiratory Failure ^* 1	2/346 (0.58%)	0/346 (0.00%)
Pneumonitis ^* 1	1/346 (0.29%)	0/346 (0.00%)
Pleural Effusion ^* 1	3/346 (0.87%)	1/346 (0.29%)
Dyspnea ^* 1	1/346 (0.29%)	4/346 (1.16%)
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other ^* 1	0/346 (0.00%)	1/346 (0.29%)
Skin Ulceration ^* 1	0/346 (0.00%)	1/346 (0.29%)
Rash Maculo-Papular ^* 1	0/346 (0.00%)	1/346 (0.29%)
Surgical and medical procedures
Surgical And Medical Procedures - Other ^* 1	2/346 (0.58%)	1/346 (0.29%)
Vascular disorders
Thromboembolic Event ^* 1	1/346 (0.29%)	9/346 (2.60%)
Peripheral Ischemia ^* 1	0/346 (0.00%)	1/346 (0.29%)
Hypotension ^* 1	3/346 (0.87%)	1/346 (0.29%)
Hypertension ^* 1	5/346 (1.45%)	0/346 (0.00%)
Hematoma ^* 1	0/346 (0.00%)	1/346 (0.29%)
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, CTCAE (4.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Arm I (Adjuvant Chemotherapy Suboptimally Debulked)	Arm II (Neoadjuvant Chemotherapy)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	343/346 (99.13%)	340/346 (98.27%)
Blood and lymphatic system disorders
Thrombotic Thrombocytopenic Purpura ^* 1	3/346 (0.87%)	2/346 (0.58%)
Lymph Node Pain ^* 1	1/346 (0.29%)	1/346 (0.29%)
Leukocytosis ^* 1	1/346 (0.29%)	0/346 (0.00%)
Blood And Lymphatic System Disorders - Other ^* 1	8/346 (2.31%)	13/346 (3.76%)
Anemia ^* 1	324/346 (93.64%)	336/346 (97.11%)
Disseminated Intravascular Coagulation ^* 1	1/346 (0.29%)	0/346 (0.00%)
Bone Marrow Hypocellular ^* 1	1/346 (0.29%)	0/346 (0.00%)
Febrile Neutropenia ^* 1	6/346 (1.73%)	6/346 (1.73%)
Cardiac disorders
Atrial Fibrillation ^* 1	0/346 (0.00%)	6/346 (1.73%)
Ventricular Tachycardia ^* 1	0/346 (0.00%)	1/346 (0.29%)
Supraventricular Tachycardia ^* 1	0/346 (0.00%)	3/346 (0.87%)
Sinus Bradycardia ^* 1	1/346 (0.29%)	2/346 (0.58%)
Palpitations ^* 1	10/346 (2.89%)	24/346 (6.94%)
Left Ventricular Systolic Dysfunction ^* 1	1/346 (0.29%)	1/346 (0.29%)
Acute Coronary Syndrome ^* 1	1/346 (0.29%)	0/346 (0.00%)
Ventricular Fibrillation ^* 1	0/346 (0.00%)	1/346 (0.29%)
Cardiac Disorders - Other ^* 1	0/346 (0.00%)	1/346 (0.29%)
Pericardial Effusion ^* 1	1/346 (0.29%)	1/346 (0.29%)
Ventricular Arrhythmia ^* 1	0/346 (0.00%)	2/346 (0.58%)
Paroxysmal Atrial Tachycardia ^* 1	2/346 (0.58%)	0/346 (0.00%)
Sinus Tachycardia ^* 1	12/346 (3.47%)	17/346 (4.91%)
Chest Pain - Cardiac ^* 1	5/346 (1.45%)	6/346 (1.73%)
Ear and labyrinth disorders
Middle Ear Inflammation ^* 1	0/346 (0.00%)	2/346 (0.58%)
Vertigo ^* 1	6/346 (1.73%)	10/346 (2.89%)
Tinnitus ^* 1	28/346 (8.09%)	20/346 (5.78%)
Hearing Impaired ^* 1	14/346 (4.05%)	13/346 (3.76%)
Ear Pain ^* 1	8/346 (2.31%)	10/346 (2.89%)
External Ear Inflammation ^* 1	0/346 (0.00%)	1/346 (0.29%)
Endocrine disorders
Adrenal Insufficiency ^* 1	0/346 (0.00%)	1/346 (0.29%)
Hypothyroidism ^* 1	0/346 (0.00%)	3/346 (0.87%)
Hyperthyroidism ^* 1	1/346 (0.29%)	1/346 (0.29%)
Endocrine Disorders - Other ^* 1	2/346 (0.58%)	1/346 (0.29%)
Cushingoid ^* 1	0/346 (0.00%)	1/346 (0.29%)
Eye disorders
Eye Disorders - Other ^* 1	10/346 (2.89%)	10/346 (2.89%)
Watering Eyes ^* 1	11/346 (3.18%)	15/346 (4.34%)
Flashing Lights ^* 1	3/346 (0.87%)	3/346 (0.87%)
Eye Pain ^* 1	4/346 (1.16%)	1/346 (0.29%)
Glaucoma ^* 1	1/346 (0.29%)	0/346 (0.00%)
Cataract ^* 1	1/346 (0.29%)	2/346 (0.58%)
Photophobia ^* 1	1/346 (0.29%)	0/346 (0.00%)
Conjunctivitis ^* 1	2/346 (0.58%)	2/346 (0.58%)
Retinal Vascular Disorder ^* 1	1/346 (0.29%)	0/346 (0.00%)
Blurred Vision ^* 1	47/346 (13.58%)	51/346 (14.74%)
Dry Eye ^* 1	3/346 (0.87%)	9/346 (2.60%)
Floaters ^* 1	12/346 (3.47%)	11/346 (3.18%)
Vitreous Hemorrhage ^* 1	0/346 (0.00%)	1/346 (0.29%)
Gastrointestinal disorders
Enterocolitis ^* 1	1/346 (0.29%)	1/346 (0.29%)
Dysphagia ^* 1	11/346 (3.18%)	14/346 (4.05%)
Dyspepsia ^* 1	21/346 (6.07%)	28/346 (8.09%)
Dry Mouth ^* 1	12/346 (3.47%)	10/346 (2.89%)
Colonic Obstruction ^* 1	2/346 (0.58%)	0/346 (0.00%)
Colonic Perforation ^* 1	2/346 (0.58%)	1/346 (0.29%)
Colonic Fistula ^* 1	2/346 (0.58%)	2/346 (0.58%)
Colitis ^* 1	6/346 (1.73%)	2/346 (0.58%)
Colonic Hemorrhage ^* 1	0/346 (0.00%)	1/346 (0.29%)
Constipation ^* 1	226/346 (65.32%)	214/346 (61.85%)
Diarrhea ^* 1	146/346 (42.20%)	153/346 (44.22%)
Vomiting ^* 1	133/346 (38.44%)	115/346 (33.24%)
Bloating ^* 1	32/346 (9.25%)	21/346 (6.07%)
Stomach Pain ^* 1	7/346 (2.02%)	3/346 (0.87%)
Salivary Duct Inflammation ^* 1	0/346 (0.00%)	2/346 (0.58%)
Small Intestinal Obstruction ^* 1	1/346 (0.29%)	2/346 (0.58%)
Anal Hemorrhage ^* 1	3/346 (0.87%)	1/346 (0.29%)
Rectal Ulcer ^* 1	0/346 (0.00%)	1/346 (0.29%)
Anal Mucositis ^* 1	1/346 (0.29%)	0/346 (0.00%)
Rectal Fistula ^* 1	0/346 (0.00%)	3/346 (0.87%)
Rectal Mucositis ^* 1	0/346 (0.00%)	1/346 (0.29%)
Abdominal Pain ^* 1	139/346 (40.17%)	138/346 (39.88%)
Proctitis ^* 1	0/346 (0.00%)	1/346 (0.29%)
Periodontal Disease ^* 1	3/346 (0.87%)	1/346 (0.29%)
Rectal Hemorrhage ^* 1	16/346 (4.62%)	7/346 (2.02%)
Oral Dysesthesia ^* 1	3/346 (0.87%)	3/346 (0.87%)
Mucositis Oral ^* 1	76/346 (21.97%)	93/346 (26.88%)
Lower Gastrointestinal Hemorrhage ^* 1	0/346 (0.00%)	2/346 (0.58%)
Gastrointestinal Disorders - Other ^* 1	14/346 (4.05%)	16/346 (4.62%)
Anal Pain ^* 1	0/346 (0.00%)	4/346 (1.16%)
Oral Hemorrhage ^* 1	15/346 (4.34%)	8/346 (2.31%)
Ileus ^* 1	5/346 (1.45%)	5/346 (1.45%)
Ileal Fistula ^* 1	1/346 (0.29%)	0/346 (0.00%)
Anal Ulcer ^* 1	0/346 (0.00%)	1/346 (0.29%)
Gastrointestinal Pain ^* 1	5/346 (1.45%)	7/346 (2.02%)
Gastric Hemorrhage ^* 1	1/346 (0.29%)	0/346 (0.00%)
Gingival Pain ^* 1	7/346 (2.02%)	3/346 (0.87%)
Oral Pain ^* 1	14/346 (4.05%)	16/346 (4.62%)
Abdominal Distension ^* 1	25/346 (7.23%)	15/346 (4.34%)
Nausea ^* 1	239/346 (69.08%)	215/346 (62.14%)
Pancreatitis ^* 1	0/346 (0.00%)	1/346 (0.29%)
Gastroparesis ^* 1	2/346 (0.58%)	3/346 (0.87%)
Gastrointestinal Fistula ^* 1	0/346 (0.00%)	1/346 (0.29%)
Gastric Ulcer ^* 1	1/346 (0.29%)	0/346 (0.00%)
Gastroesophageal Reflux Disease ^* 1	21/346 (6.07%)	27/346 (7.80%)
Rectal Pain ^* 1	1/346 (0.29%)	8/346 (2.31%)
Lip Pain ^* 1	1/346 (0.29%)	0/346 (0.00%)
Gastric Fistula ^* 1	0/346 (0.00%)	1/346 (0.29%)
Esophageal Ulcer ^* 1	0/346 (0.00%)	1/346 (0.29%)
Esophagitis ^* 1	2/346 (0.58%)	1/346 (0.29%)
Fecal Incontinence ^* 1	0/346 (0.00%)	3/346 (0.87%)
Hemorrhoidal Hemorrhage ^* 1	8/346 (2.31%)	10/346 (2.89%)
Hemorrhoids ^* 1	14/346 (4.05%)	20/346 (5.78%)
Ascites ^* 1	14/346 (4.05%)	4/346 (1.16%)
Toothache ^* 1	11/346 (3.18%)	1/346 (0.29%)
Jejunal Obstruction ^* 1	0/346 (0.00%)	1/346 (0.29%)
Anal Fistula ^* 1	1/346 (0.29%)	0/346 (0.00%)
Esophageal Pain ^* 1	0/346 (0.00%)	2/346 (0.58%)
Dental Caries ^* 1	4/346 (1.16%)	2/346 (0.58%)
Flatulence ^* 1	11/346 (3.18%)	10/346 (2.89%)
Gastritis ^* 1	5/346 (1.45%)	5/346 (1.45%)
General disorders
General Disorders And Administration Site Conditio ^* 1	3/346 (0.87%)	8/346 (2.31%)
Pain ^* 1	93/346 (26.88%)	86/346 (24.86%)
Neck Edema ^* 1	1/346 (0.29%)	1/346 (0.29%)
Malaise ^* 1	8/346 (2.31%)	6/346 (1.73%)
Localized Edema ^* 1	5/346 (1.45%)	4/346 (1.16%)
Irritability ^* 1	1/346 (0.29%)	0/346 (0.00%)
Injection Site Reaction ^* 1	0/346 (0.00%)	2/346 (0.58%)
Infusion Site Extravasation ^* 1	0/346 (0.00%)	2/346 (0.58%)
Flu Like Symptoms ^* 1	13/346 (3.76%)	8/346 (2.31%)
Edema Trunk ^* 1	2/346 (0.58%)	3/346 (0.87%)
Non-Cardiac Chest Pain ^* 1	14/346 (4.05%)	11/346 (3.18%)
Edema Limbs ^* 1	54/346 (15.61%)	65/346 (18.79%)
Facial Pain ^* 1	4/346 (1.16%)	4/346 (1.16%)
Edema Face ^* 1	4/346 (1.16%)	3/346 (0.87%)
Fatigue ^* 1	293/346 (84.68%)	300/346 (86.71%)
Fever ^* 1	26/346 (7.51%)	38/346 (10.98%)
Gait Disturbance ^* 1	5/346 (1.45%)	9/346 (2.60%)
Chills ^* 1	14/346 (4.05%)	23/346 (6.65%)
Infusion Related Reaction ^* 1	12/346 (3.47%)	15/346 (4.34%)
Hepatobiliary disorders
Hepatobiliary Disorders - Other ^* 1	1/346 (0.29%)	0/346 (0.00%)
Hepatic Pain ^* 1	1/346 (0.29%)	0/346 (0.00%)
Portal Vein Thrombosis ^* 1	1/346 (0.29%)	0/346 (0.00%)
Cholecystitis ^* 1	0/346 (0.00%)	1/346 (0.29%)
Immune system disorders
Allergic Reaction ^* 1	18/346 (5.20%)	11/346 (3.18%)
Cytokine Release Syndrome ^* 1	1/346 (0.29%)	0/346 (0.00%)
Immune System Disorders - Other ^* 1	1/346 (0.29%)	1/346 (0.29%)
Infections and infestations
Infections And Infestations - Other ^* 1	12/346 (3.47%)	11/346 (3.18%)
Wound Infection ^* 1	9/346 (2.60%)	6/346 (1.73%)
Upper Respiratory Infection ^* 1	19/346 (5.49%)	16/346 (4.62%)
Tooth Infection ^* 1	8/346 (2.31%)	9/346 (2.60%)
Stoma Site Infection ^* 1	0/346 (0.00%)	1/346 (0.29%)
Vulval Infection ^* 1	3/346 (0.87%)	2/346 (0.58%)
Skin Infection ^* 1	5/346 (1.45%)	17/346 (4.91%)
Sinusitis ^* 1	15/346 (4.34%)	16/346 (4.62%)
Sepsis ^* 1	1/346 (0.29%)	3/346 (0.87%)
Salivary Gland Infection ^* 1	0/346 (0.00%)	1/346 (0.29%)
Rhinitis Infective ^* 1	4/346 (1.16%)	1/346 (0.29%)
Rash Pustular ^* 1	1/346 (0.29%)	0/346 (0.00%)
Pleural Infection ^* 1	0/346 (0.00%)	1/346 (0.29%)
Pharyngitis ^* 1	0/346 (0.00%)	2/346 (0.58%)
Peritoneal Infection ^* 1	0/346 (0.00%)	1/346 (0.29%)
Peripheral Nerve Infection ^* 1	1/346 (0.29%)	0/346 (0.00%)
Otitis Media ^* 1	1/346 (0.29%)	0/346 (0.00%)
Papulopustular Rash ^* 1	3/346 (0.87%)	3/346 (0.87%)
Otitis Externa ^* 1	1/346 (0.29%)	1/346 (0.29%)
Nail Infection ^* 1	4/346 (1.16%)	7/346 (2.02%)
Mucosal Infection ^* 1	4/346 (1.16%)	4/346 (1.16%)
Pelvic Infection ^* 1	1/346 (0.29%)	1/346 (0.29%)
Lung Infection ^* 1	3/346 (0.87%)	3/346 (0.87%)
Laryngitis ^* 1	1/346 (0.29%)	3/346 (0.87%)
Kidney Infection ^* 1	1/346 (0.29%)	0/346 (0.00%)
Hepatitis Viral ^* 1	1/346 (0.29%)	0/346 (0.00%)
Eye Infection ^* 1	0/346 (0.00%)	2/346 (0.58%)
Esophageal Infection ^* 1	1/346 (0.29%)	0/346 (0.00%)
Duodenal Infection ^* 1	0/346 (0.00%)	1/346 (0.29%)
Device Related Infection ^* 1	0/346 (0.00%)	2/346 (0.58%)
Conjunctivitis Infective ^* 1	0/346 (0.00%)	1/346 (0.29%)
Gum Infection ^* 1	2/346 (0.58%)	1/346 (0.29%)
Vaginal Infection ^* 1	9/346 (2.60%)	5/346 (1.45%)
Urinary Tract Infection ^* 1	44/346 (12.72%)	52/346 (15.03%)
Catheter Related Infection ^* 1	1/346 (0.29%)	5/346 (1.45%)
Bronchial Infection ^* 1	5/346 (1.45%)	3/346 (0.87%)
Enterocolitis Infectious ^* 1	4/346 (1.16%)	3/346 (0.87%)
Bladder Infection ^* 1	3/346 (0.87%)	8/346 (2.31%)
Lip Infection ^* 1	1/346 (0.29%)	0/346 (0.00%)
Anorectal Infection ^* 1	1/346 (0.29%)	1/346 (0.29%)
Abdominal Infection ^* 1	1/346 (0.29%)	3/346 (0.87%)
Injury, poisoning and procedural complications
Injury, Poisoning And Procedural Complications - O ^* 1	2/346 (0.58%)	1/346 (0.29%)
Wrist Fracture ^* 1	3/346 (0.87%)	0/346 (0.00%)
Wound Dehiscence ^* 1	5/346 (1.45%)	7/346 (2.02%)
Vascular Access Complication ^* 1	1/346 (0.29%)	4/346 (1.16%)
Vaginal Anastomotic Leak ^* 1	0/346 (0.00%)	2/346 (0.58%)
Spinal Fracture ^* 1	1/346 (0.29%)	0/346 (0.00%)
Seroma ^* 1	2/346 (0.58%)	3/346 (0.87%)
Tracheal Obstruction ^* 1	0/346 (0.00%)	1/346 (0.29%)
Intestinal Stoma Site Bleeding ^* 1	0/346 (0.00%)	1/346 (0.29%)
Stomal Ulcer ^* 1	0/346 (0.00%)	1/346 (0.29%)
Fracture ^* 1	1/346 (0.29%)	3/346 (0.87%)
Fall ^* 1	8/346 (2.31%)	9/346 (2.60%)
Wound Complication ^* 1	17/346 (4.91%)	13/346 (3.76%)
Intraoperative Musculoskeletal Injury ^* 1	1/346 (0.29%)	0/346 (0.00%)
Burn ^* 1	2/346 (0.58%)	2/346 (0.58%)
Bruising ^* 1	20/346 (5.78%)	17/346 (4.91%)
Ankle Fracture ^* 1	1/346 (0.29%)	0/346 (0.00%)
Investigations
Investigations - Other ^* 1	15/346 (4.34%)	14/346 (4.05%)
Weight Loss ^* 1	56/346 (16.18%)	48/346 (13.87%)
Weight Gain ^* 1	53/346 (15.32%)	39/346 (11.27%)
Serum Amylase Increased ^* 1	1/346 (0.29%)	0/346 (0.00%)
Platelet Count Decreased ^* 1	257/346 (74.28%)	274/346 (79.19%)
Pancreatic Enzymes Decreased ^* 1	0/346 (0.00%)	2/346 (0.58%)
Lymphocyte Count Decreased ^* 1	18/346 (5.20%)	36/346 (10.40%)
Lipase Increased ^* 1	1/346 (0.29%)	0/346 (0.00%)
Inr Increased ^* 1	5/346 (1.45%)	9/346 (2.60%)
Hemoglobin Increased ^* 1	1/346 (0.29%)	1/346 (0.29%)
Ggt Increased ^* 1	2/346 (0.58%)	5/346 (1.45%)
Ejection Fraction Decreased ^* 1	1/346 (0.29%)	0/346 (0.00%)
Creatinine Increased ^* 1	24/346 (6.94%)	34/346 (9.83%)
Cholesterol High ^* 1	6/346 (1.73%)	5/346 (1.45%)
Neutrophil Count Decreased ^* 1	325/346 (93.93%)	331/346 (95.66%)
Urine Output Decreased ^* 1	0/346 (0.00%)	1/346 (0.29%)
Cardiac Troponin I Increased ^* 1	1/346 (0.29%)	0/346 (0.00%)
Cpk Increased ^* 1	0/346 (0.00%)	1/346 (0.29%)
Blood Bilirubin Increased ^* 1	7/346 (2.02%)	8/346 (2.31%)
White Blood Cell Decreased ^* 1	321/346 (92.77%)	332/346 (95.95%)
Aspartate Aminotransferase Increased ^* 1	40/346 (11.56%)	42/346 (12.14%)
Alkaline Phosphatase Increased ^* 1	41/346 (11.85%)	47/346 (13.58%)
Alanine Aminotransferase Increased ^* 1	38/346 (10.98%)	39/346 (11.27%)
Activated Partial Thromboplastin Time Prolonged ^* 1	1/346 (0.29%)	6/346 (1.73%)
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders - Other ^* 1	11/346 (3.18%)	6/346 (1.73%)
Hypophosphatemia ^* 1	10/346 (2.89%)	22/346 (6.36%)
Hyponatremia ^* 1	57/346 (16.47%)	63/346 (18.21%)
Hypomagnesemia ^* 1	68/346 (19.65%)	86/346 (24.86%)
Hypokalemia ^* 1	60/346 (17.34%)	66/346 (19.08%)
Hypoglycemia ^* 1	14/346 (4.05%)	15/346 (4.34%)
Hypocalcemia ^* 1	28/346 (8.09%)	48/346 (13.87%)
Hypoalbuminemia ^* 1	49/346 (14.16%)	65/346 (18.79%)
Hyperuricemia ^* 1	2/346 (0.58%)	2/346 (0.58%)
Hypertriglyceridemia ^* 1	2/346 (0.58%)	4/346 (1.16%)
Hypernatremia ^* 1	9/346 (2.60%)	10/346 (2.89%)
Hypermagnesemia ^* 1	4/346 (1.16%)	5/346 (1.45%)
Hyperkalemia ^* 1	16/346 (4.62%)	15/346 (4.34%)
Hyperglycemia ^* 1	73/346 (21.10%)	82/346 (23.70%)
Hypercalcemia ^* 1	17/346 (4.91%)	13/346 (3.76%)
Glucose Intolerance ^* 1	4/346 (1.16%)	1/346 (0.29%)
Dehydration ^* 1	36/346 (10.40%)	38/346 (10.98%)
Anorexia ^* 1	102/346 (29.48%)	116/346 (33.53%)
Acidosis ^* 1	2/346 (0.58%)	0/346 (0.00%)
Musculoskeletal and connective tissue disorders
Superficial Soft Tissue Fibrosis ^* 1	0/346 (0.00%)	1/346 (0.29%)
Pain In Extremity ^* 1	80/346 (23.12%)	69/346 (19.94%)
Osteoporosis ^* 1	1/346 (0.29%)	3/346 (0.87%)
Neck Pain ^* 1	21/346 (6.07%)	15/346 (4.34%)
Myositis ^* 1	2/346 (0.58%)	0/346 (0.00%)
Myalgia ^* 1	91/346 (26.30%)	75/346 (21.68%)
Musculoskeletal Deformity ^* 1	0/346 (0.00%)	1/346 (0.29%)
Muscle Weakness Upper Limb ^* 1	4/346 (1.16%)	3/346 (0.87%)
Muscle Weakness Trunk ^* 1	1/346 (0.29%)	2/346 (0.58%)
Muscle Weakness Lower Limb ^* 1	15/346 (4.34%)	13/346 (3.76%)
Muscle Weakness Right-Sided ^* 1	0/346 (0.00%)	2/346 (0.58%)
Muscle Weakness Left-Sided ^* 1	0/346 (0.00%)	2/346 (0.58%)
Joint Range Of Motion Decreased Cervical Spine ^* 1	1/346 (0.29%)	0/346 (0.00%)
Joint Range Of Motion Decreased ^* 1	4/346 (1.16%)	7/346 (2.02%)
Joint Effusion ^* 1	1/346 (0.29%)	3/346 (0.87%)
Generalized Muscle Weakness ^* 1	35/346 (10.12%)	44/346 (12.72%)
Flank Pain ^* 1	10/346 (2.89%)	3/346 (0.87%)
Chest Wall Pain ^* 1	7/346 (2.02%)	14/346 (4.05%)
Trismus ^* 1	1/346 (0.29%)	0/346 (0.00%)
Buttock Pain ^* 1	1/346 (0.29%)	1/346 (0.29%)
Bone Pain ^* 1	33/346 (9.54%)	25/346 (7.23%)
Back Pain ^* 1	70/346 (20.23%)	54/346 (15.61%)
Arthritis ^* 1	19/346 (5.49%)	18/346 (5.20%)
Arthralgia ^* 1	119/346 (34.39%)	83/346 (23.99%)
Musculoskeletal And Connective Tissue Disorder - ^* 1	4/346 (1.16%)	8/346 (2.31%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Including cysts and polyps ^* 1	5/346 (1.45%)	3/346 (0.87%)
Tumor Pain ^* 1	1/346 (0.29%)	1/346 (0.29%)
Nervous system disorders
Nervous System Disorders - Other ^* 1	3/346 (0.87%)	6/346 (1.73%)
Tremor ^* 1	4/346 (1.16%)	9/346 (2.60%)
Transient Ischemic Attacks ^* 1	1/346 (0.29%)	1/346 (0.29%)
Somnolence ^* 1	1/346 (0.29%)	1/346 (0.29%)
Reversible Posterior Leukoencephalopathy Syndrome ^* 1	1/346 (0.29%)	0/346 (0.00%)
Presyncope ^* 1	1/346 (0.29%)	3/346 (0.87%)
Peripheral Sensory Neuropathy ^* 1	244/346 (70.52%)	233/346 (67.34%)
Peripheral Motor Neuropathy ^* 1	19/346 (5.49%)	20/346 (5.78%)
Paresthesia ^* 1	19/346 (5.49%)	24/346 (6.94%)
Nystagmus ^* 1	0/346 (0.00%)	1/346 (0.29%)
Neuralgia ^* 1	5/346 (1.45%)	6/346 (1.73%)
Memory Impairment ^* 1	20/346 (5.78%)	20/346 (5.78%)
Lethargy ^* 1	0/346 (0.00%)	1/346 (0.29%)
Movements Involuntary ^* 1	5/346 (1.45%)	3/346 (0.87%)
Hypersomnia ^* 1	1/346 (0.29%)	0/346 (0.00%)
Headache ^* 1	116/346 (33.53%)	112/346 (32.37%)
Facial Nerve Disorder ^* 1	0/346 (0.00%)	1/346 (0.29%)
Extrapyramidal Disorder ^* 1	2/346 (0.58%)	0/346 (0.00%)
Radiculitis ^* 1	0/346 (0.00%)	1/346 (0.29%)
Encephalopathy ^* 1	1/346 (0.29%)	0/346 (0.00%)
Dysphasia ^* 1	2/346 (0.58%)	2/346 (0.58%)
Dysgeusia ^* 1	42/346 (12.14%)	58/346 (16.76%)
Sinus Pain ^* 1	5/346 (1.45%)	6/346 (1.73%)
Dysesthesia ^* 1	0/346 (0.00%)	2/346 (0.58%)
Dysarthria ^* 1	1/346 (0.29%)	1/346 (0.29%)
Syncope ^* 1	8/346 (2.31%)	6/346 (1.73%)
Dizziness ^* 1	61/346 (17.63%)	66/346 (19.08%)
Concentration Impairment ^* 1	1/346 (0.29%)	4/346 (1.16%)
Cognitive Disturbance ^* 1	7/346 (2.02%)	5/346 (1.45%)
Ataxia ^* 1	3/346 (0.87%)	4/346 (1.16%)
Amnesia ^* 1	1/346 (0.29%)	1/346 (0.29%)
Akathisia ^* 1	1/346 (0.29%)	1/346 (0.29%)
Psychiatric disorders
Psychiatric Disorders - Other ^* 1	2/346 (0.58%)	1/346 (0.29%)
Suicidal Ideation ^* 1	1/346 (0.29%)	0/346 (0.00%)
Psychosis ^* 1	0/346 (0.00%)	1/346 (0.29%)
Restlessness ^* 1	8/346 (2.31%)	6/346 (1.73%)
Libido Decreased ^* 1	1/346 (0.29%)	1/346 (0.29%)
Insomnia ^* 1	90/346 (26.01%)	85/346 (24.57%)
Depression ^* 1	66/346 (19.08%)	66/346 (19.08%)
Delirium ^* 1	0/346 (0.00%)	1/346 (0.29%)
Confusion ^* 1	5/346 (1.45%)	5/346 (1.45%)
Anxiety ^* 1	60/346 (17.34%)	68/346 (19.65%)
Agitation ^* 1	4/346 (1.16%)	7/346 (2.02%)
Renal and urinary disorders
Renal And Urinary Disorders - Other ^* 1	4/346 (1.16%)	12/346 (3.47%)
Urine Discoloration ^* 1	0/346 (0.00%)	1/346 (0.29%)
Urinary Urgency ^* 1	9/346 (2.60%)	11/346 (3.18%)
Urinary Tract Obstruction ^* 1	2/346 (0.58%)	3/346 (0.87%)
Urinary Retention ^* 1	4/346 (1.16%)	7/346 (2.02%)
Urinary Incontinence ^* 1	13/346 (3.76%)	17/346 (4.91%)
Urinary Tract Pain ^* 1	16/346 (4.62%)	18/346 (5.20%)
Urinary Frequency ^* 1	14/346 (4.05%)	34/346 (9.83%)
Urinary Fistula ^* 1	0/346 (0.00%)	1/346 (0.29%)
Renal Calculi ^* 1	1/346 (0.29%)	1/346 (0.29%)
Proteinuria ^* 1	47/346 (13.58%)	55/346 (15.90%)
Hematuria ^* 1	11/346 (3.18%)	13/346 (3.76%)
Cystitis Noninfective ^* 1	0/346 (0.00%)	3/346 (0.87%)
Chronic Kidney Disease ^* 1	2/346 (0.58%)	6/346 (1.73%)
Bladder Spasm ^* 1	3/346 (0.87%)	2/346 (0.58%)
Acute Kidney Injury ^* 1	3/346 (0.87%)	2/346 (0.58%)
Reproductive system and breast disorders
Reproductive System And Breast Disorders - Other ^* 1	3/346 (0.87%)	2/346 (0.58%)
Vaginal Pain ^* 1	4/346 (1.16%)	7/346 (2.02%)
Vaginal Hemorrhage ^* 1	4/346 (1.16%)	7/346 (2.02%)
Vaginal Fistula ^* 1	1/346 (0.29%)	4/346 (1.16%)
Vaginal Dryness ^* 1	8/346 (2.31%)	6/346 (1.73%)
Perineal Pain ^* 1	0/346 (0.00%)	1/346 (0.29%)
Pelvic Pain ^* 1	11/346 (3.18%)	8/346 (2.31%)
Menorrhagia ^* 1	0/346 (0.00%)	1/346 (0.29%)
Vaginal Discharge ^* 1	7/346 (2.02%)	17/346 (4.91%)
Vaginal Inflammation ^* 1	1/346 (0.29%)	3/346 (0.87%)
Genital Edema ^* 1	0/346 (0.00%)	2/346 (0.58%)
Dyspareunia ^* 1	5/346 (1.45%)	4/346 (1.16%)
Breast Pain ^* 1	1/346 (0.29%)	3/346 (0.87%)
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders - ^* 1	5/346 (1.45%)	6/346 (1.73%)
Voice Alteration ^* 1	15/346 (4.34%)	15/346 (4.34%)
Sore Throat ^* 1	27/346 (7.80%)	25/346 (7.23%)
Sneezing ^* 1	4/346 (1.16%)	2/346 (0.58%)
Sinus Disorder ^* 1	10/346 (2.89%)	12/346 (3.47%)
Respiratory Failure ^* 1	0/346 (0.00%)	1/346 (0.29%)
Pulmonary Hypertension ^* 1	0/346 (0.00%)	2/346 (0.58%)
Postnasal Drip ^* 1	22/346 (6.36%)	24/346 (6.94%)
Pneumothorax ^* 1	1/346 (0.29%)	0/346 (0.00%)
Pneumonitis ^* 1	1/346 (0.29%)	0/346 (0.00%)
Pleural Effusion ^* 1	12/346 (3.47%)	9/346 (2.60%)
Pharyngolaryngeal Pain ^* 1	3/346 (0.87%)	1/346 (0.29%)
Pharyngeal Mucositis ^* 1	1/346 (0.29%)	2/346 (0.58%)
Pharyngeal Hemorrhage ^* 1	1/346 (0.29%)	1/346 (0.29%)
Nasal Congestion ^* 1	42/346 (12.14%)	45/346 (13.01%)
Pleuritic Pain ^* 1	2/346 (0.58%)	3/346 (0.87%)
Productive Cough ^* 1	3/346 (0.87%)	8/346 (2.31%)
Laryngeal Inflammation ^* 1	2/346 (0.58%)	1/346 (0.29%)
Laryngeal Hemorrhage ^* 1	0/346 (0.00%)	1/346 (0.29%)
Hoarseness ^* 1	20/346 (5.78%)	25/346 (7.23%)
Sleep Apnea ^* 1	0/346 (0.00%)	2/346 (0.58%)
Hiccups ^* 1	0/346 (0.00%)	1/346 (0.29%)
Epistaxis ^* 1	89/346 (25.72%)	131/346 (37.86%)
Dyspnea ^* 1	120/346 (34.68%)	131/346 (37.86%)
Cough ^* 1	76/346 (21.97%)	90/346 (26.01%)
Wheezing ^* 1	3/346 (0.87%)	9/346 (2.60%)
Atelectasis ^* 1	2/346 (0.58%)	3/346 (0.87%)
Aspiration ^* 1	0/346 (0.00%)	1/346 (0.29%)
Allergic Rhinitis ^* 1	39/346 (11.27%)	46/346 (13.29%)
Adult Respiratory Distress Syndrome ^* 1	0/346 (0.00%)	1/346 (0.29%)
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other ^* 1	28/346 (8.09%)	33/346 (9.54%)
Urticaria ^* 1	1/346 (0.29%)	2/346 (0.58%)
Skin Ulceration ^* 1	10/346 (2.89%)	4/346 (1.16%)
Skin Induration ^* 1	2/346 (0.58%)	3/346 (0.87%)
Skin Hyperpigmentation ^* 1	7/346 (2.02%)	9/346 (2.60%)
Scalp Pain ^* 1	5/346 (1.45%)	2/346 (0.58%)
Rash Acneiform ^* 1	18/346 (5.20%)	24/346 (6.94%)
Purpura ^* 1	1/346 (0.29%)	3/346 (0.87%)
Pruritus ^* 1	24/346 (6.94%)	22/346 (6.36%)
Photosensitivity ^* 1	1/346 (0.29%)	1/346 (0.29%)
Periorbital Edema ^* 1	1/346 (0.29%)	0/346 (0.00%)
Palmar-Plantar Erythrodysesthesia Syndrome ^* 1	1/346 (0.29%)	5/346 (1.45%)
Pain Of Skin ^* 1	3/346 (0.87%)	7/346 (2.02%)
Rash Maculo-Papular ^* 1	43/346 (12.43%)	74/346 (21.39%)
Skin Hypopigmentation ^* 1	0/346 (0.00%)	2/346 (0.58%)
Nail Ridging ^* 1	12/346 (3.47%)	9/346 (2.60%)
Nail Loss ^* 1	6/346 (1.73%)	20/346 (5.78%)
Nail Discoloration ^* 1	13/346 (3.76%)	33/346 (9.54%)
Hypertrichosis ^* 1	1/346 (0.29%)	0/346 (0.00%)
Hyperhidrosis ^* 1	8/346 (2.31%)	1/346 (0.29%)
Hirsutism ^* 1	0/346 (0.00%)	1/346 (0.29%)
Erythroderma ^* 1	0/346 (0.00%)	2/346 (0.58%)
Erythema Multiforme ^* 1	5/346 (1.45%)	3/346 (0.87%)
Dry Skin ^* 1	24/346 (6.94%)	36/346 (10.40%)
Bullous Dermatitis ^* 1	0/346 (0.00%)	2/346 (0.58%)
Body Odor ^* 1	1/346 (0.29%)	0/346 (0.00%)
Alopecia ^* 1	258/346 (74.57%)	235/346 (67.92%)
Social circumstances
Social Circumstances - Other ^* 1	6/346 (1.73%)	2/346 (0.58%)
Menopause ^* 1	1/346 (0.29%)	0/346 (0.00%)
Surgical and medical procedures
Surgical And Medical Procedures - Other ^* 1	8/346 (2.31%)	11/346 (3.18%)
Vascular disorders
Vascular Disorders - Other ^* 1	1/346 (0.29%)	4/346 (1.16%)
Thromboembolic Event ^* 1	23/346 (6.65%)	21/346 (6.07%)
Superficial Thrombophlebitis ^* 1	1/346 (0.29%)	1/346 (0.29%)
Phlebitis ^* 1	0/346 (0.00%)	1/346 (0.29%)
Peripheral Ischemia ^* 1	1/346 (0.29%)	0/346 (0.00%)
Lymphocele ^* 1	2/346 (0.58%)	2/346 (0.58%)
Lymphedema ^* 1	8/346 (2.31%)	12/346 (3.47%)
Hypotension ^* 1	13/346 (3.76%)	14/346 (4.05%)
Hypertension ^* 1	136/346 (39.31%)	122/346 (35.26%)
Hot Flashes ^* 1	44/346 (12.72%)	39/346 (11.27%)
Hematoma ^* 1	4/346 (1.16%)	3/346 (0.87%)
Flushing ^* 1	9/346 (2.60%)	9/346 (2.60%)
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, CTCAE (4.0)

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

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Name/Title:	Linda Gedeon for Mark Brady, PhD.
Organization:	NRG Oncology
Phone:	716-845-1169
EMail:	lgedeon@gogstats.org

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

Chan JK, Brady MF, Penson RT, Huang H, Birrer MJ, Walker JL, DiSilvestro PA, Rubin SC, Martin LP, Davidson SA, Huh WK, O'Malley DM, Boente MP, Michael H, Monk BJ. Weekly vs. Every-3-Week Paclitaxel and Carboplatin for Ovarian Cancer. N Engl J Med. 2016 Feb 25;374(8):738-48. doi: 10.1056/NEJMoa1505067.

Layout table for additonal information

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT01167712
Other Study ID Numbers:	NCI-2011-03812 NCI-2011-03812 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) GOG-0262/ACRIN 6695 11-00374 CDR0000681448 ACRIN 6695 GOG-0262 ( Other Identifier: NRG Oncology ) GOG-0262 ( Other Identifier: CTEP ) U10CA180868 ( U.S. NIH Grant/Contract ) U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted:	July 21, 2010
First Posted:	July 22, 2010
Results First Submitted:	October 2, 2017
Results First Posted:	January 23, 2018
Last Update Posted:	May 16, 2024

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