Trial · NCT01167712
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
NCT01167712, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2018-01-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT01167712. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01167712
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT01167712
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 692 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- 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
- Bevacizumab, Carboplatin, Computed Tomography, Paclitaxel, Therapeutic Conventional Surgery
- First posted
- 2010-07-22
- Last updated
- 2026-11-12
- Results first posted
- 2018-01-23
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival | The timeframe is from enrollment onto the study up to 3 years following enrollment. | 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. |
| Secondary | Median Duration of First Quartile Survival | The timeframe is from enrollment onto the study up to 3 years after enrollment | First Quartile Overall Survival |
| Secondary | Quality of Life Score as Measured by Functional Assessment of Cancer Therapy-Ovary-Total Outcome Index (Fact-O TOI) | 18 weeks after enrolling on the study, which is the time it takes to complete 6 cycles of treatment plus 3 weeks | 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) |
| Other | 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 | Baseline (T0) up to 10 days after the start of course 2 (T2) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival | The timeframe is from enrollment onto the study up to 3 years following enrollment. | Whole sample | months | MEDIAN |
| SECONDARY | Median Duration of First Quartile Survival | The timeframe is from enrollment onto the study up to 3 years after enrollment | Whole sample | months | MEDIAN |
| SECONDARY | Quality of Life Score as Measured by Functional Assessment of Cancer Therapy-Ovary-Total Outcome Index (Fact-O TOI) | 18 weeks after enrolling on the study, which is the time it takes to complete 6 cycles of treatment plus 3 weeks | 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. | Units on a Scale | MEAN |
| OTHER_PRE_SPECIFIED | 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 | Baseline (T0) up to 10 days after the start of course 2 (T2) |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival | Arm I (Adjuvant Chemotherapy Suboptimally Debulked) | 14.7 | 95% Confidence Interval 13.5 to 15.8 | months | |
| Progression-Free Survival | Arm II (Neoadjuvant Chemotherapy) | 14.0 | 95% Confidence Interval 12.7 to 15.2 | months | |
| Median Duration of First Quartile Survival | Arm I (Adjuvant Chemotherapy Suboptimally Debulked) | 23.2 | 95% Confidence Interval 20.1 to 26.3 | months | |
| Median Duration of First Quartile Survival | Arm II (Neoadjuvant Chemotherapy) | 24 | 95% Confidence Interval 19.8 to 26.0 | months | |
| Quality of Life Score as Measured by Functional Assessment of Cancer Therapy-Ovary-Total Outcome Index (Fact-O TOI) | Arm I (Adjuvant Chemotherapy Suboptimally Debulked) | 70.9 | Standard Error 1.42 | Units on a Scale | |
| Quality of Life Score as Measured by Functional Assessment of Cancer Therapy-Ovary-Total Outcome Index (Fact-O TOI) | Arm II (Neoadjuvant Chemotherapy) | 68.2 | Standard Error 1.59 | Units on a Scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Adjuvant Chemotherapy Suboptimally Debulked) | 346 | |
| Overall Study | STARTED | Arm II (Neoadjuvant Chemotherapy) | 346 | |
| Overall Study | COMPLETED | Arm I (Adjuvant Chemotherapy Suboptimally Debulked) | 346 | |
| Overall Study | COMPLETED | Arm II (Neoadjuvant Chemotherapy) | 346 | |
| Overall Study | NOT COMPLETED | Arm I (Adjuvant Chemotherapy Suboptimally Debulked) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (Neoadjuvant Chemotherapy) | 0 |
Source ClinicalTrials.gov
Adverse events1,058
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Thrombotic Thrombocytopenic Purpura | Blood and lymphatic system disorders | Arm I (Adjuvant Chemotherapy Suboptimally Debulked) | 3 | 346 | |
| other | Thrombotic Thrombocytopenic Purpura | Blood and lymphatic system disorders | Arm II (Neoadjuvant Chemotherapy) | 2 | 346 | |
| other | Lymph Node Pain | Blood and lymphatic system disorders | Arm I (Adjuvant Chemotherapy Suboptimally Debulked) | 1 | 346 | |
| other | Lymph Node Pain | Blood and lymphatic system disorders | Arm II (Neoadjuvant Chemotherapy) | 1 | 346 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm I (Adjuvant Chemotherapy Suboptimally Debulked) | 1 | 346 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm II (Neoadjuvant Chemotherapy) | 0 | 346 | |
| other | Blood And Lymphatic System Disorders - Other | Blood and lymphatic system disorders | Arm I (Adjuvant Chemotherapy Suboptimally Debulked) | 8 | 346 | |
| other | Blood And Lymphatic System Disorders - Other | Blood and lymphatic system disorders | Arm II (Neoadjuvant Chemotherapy) | 13 | 346 | |
| other | Anemia | Blood and lymphatic system disorders | Arm I (Adjuvant Chemotherapy Suboptimally Debulked) | 324 | 346 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Neoadjuvant Chemotherapy) | 336 | 346 |
1 to 10 of 1,058Source ClinicalTrials.gov
See all 1,058 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Adjuvant Chemotherapy Suboptimally Debulked) | ||
| Total, all-cause mortality | Arm II (Neoadjuvant Chemotherapy) | ||
| Total, other adverse events | Arm I (Adjuvant Chemotherapy Suboptimally Debulked) | 343 | 346 |
| Total, other adverse events | Arm II (Neoadjuvant Chemotherapy) | 340 | 346 |
| Total, serious adverse events | Arm I (Adjuvant Chemotherapy Suboptimally Debulked) | 122 | 346 |
| Total, serious adverse events | Arm II (Neoadjuvant Chemotherapy) | 167 | 346 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA027469 | Gynecologic Oncology Group | DISAIA, PHILIP J. | GYNECOLOGIC ONCOLOGY GROUP | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I (Adjuvant Chemotherapy Suboptimally Debulked) vs Arm II (Neoadjuvant Chemotherapy): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01167712
GET https://conductscience.org/api/trials/v1/NCT01167712/events?page=2