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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01167712
Recruitment Status : Active, not recruiting
First Posted : July 22, 2010
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
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
Malignant Ovarian Mixed Epithelial Tumor
Ovarian Brenner Tumor
Ovarian Clear Cell Adenocarcinofibroma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mucinous Adenocarcinoma
Ovarian Serous Adenocarcinoma
Ovarian Transitional Cell Carcinoma
Primary Peritoneal Serous Adenocarcinoma
Stage IIA Fallopian Tube Cancer
Stage IIA Ovarian Cancer
Stage IIB Fallopian Tube Cancer
Stage IIB Ovarian Cancer
Stage IIC Fallopian Tube Cancer
Stage IIC Ovarian Cancer
Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Cancer
Stage IIIA Primary Peritoneal Cancer
Stage IIIB Fallopian Tube Cancer
Stage IIIB Ovarian Cancer
Stage IIIB Primary Peritoneal Cancer
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Cancer
Stage IIIC Primary Peritoneal Cancer
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Cancer
Stage IV Primary Peritoneal Cancer
Undifferentiated Ovarian Carcinoma
Interventions Biological: Bevacizumab
Drug: Carboplatin
Procedure: Computed Tomography
Drug: Paclitaxel
Procedure: Therapeutic Conventional Surgery
Enrollment 692
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)
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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
Arm/Group Title Arm I (Adjuvant Chemotherapy Suboptimally Debulked) Arm II (Neoadjuvant Chemotherapy) Total
Hide 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
Hide 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
1.Primary Outcome
Title Progression-Free Survival
Hide 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.
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Hide Analysis Population Description
Whole sample
Arm/Group Title Arm I (Adjuvant Chemotherapy Suboptimally Debulked) Arm II (Neoadjuvant Chemotherapy)
Hide 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)
Show Statistical Analysis 1 Hide 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
Hide Description First Quartile Overall Survival
Time Frame The timeframe is from enrollment onto the study up to 3 years after enrollment
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Hide Analysis Population Description
Whole sample
Arm/Group Title Arm I (Adjuvant Chemotherapy Suboptimally Debulked) Arm II (Neoadjuvant Chemotherapy)
Hide 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)
Show Statistical Analysis 1 Hide 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)
Hide 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
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Hide 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)
Hide 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
Hide Description [Not Specified]
Time Frame Baseline (T0) up to 10 days after the start of course 2 (T2)
Outcome Measure Data Not Reported
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)
Hide 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   --/--   --/-- 
Show Serious Adverse Events Hide 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)
Show Other (Not Including Serious) Adverse Events Hide 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)
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
Name/Title: Linda Gedeon for Mark Brady, PhD.
Organization: NRG Oncology
Phone: 716-845-1169
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01167712     History of Changes
Other Study ID Numbers: NCI-2011-03812
NCI-2011-03812 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ACRIN 6695
CDR0000681448
GOG-0262/ACRIN 6695 ( 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: January 23, 2018