Trial · NCT00011986
Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
NCT00011986, Phase 3, Completed, Gynecologic Oncology Group; results first posted 2016-04-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer. Trials, record NCT00011986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00011986
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
- NCT number
- NCT00011986
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,312 participants, actual
- Lead sponsor
- Gynecologic Oncology Group
- Conditions
- Primary Peritoneal Carcinoma, Stage III Ovarian Cancer, Stage IV Ovarian Cancer
- Interventions
- Paclitaxel, Carboplatin, Gemcitabine Hydrochloride, Pegylated Liposomal Doxorubicin Hydrochloride, Topotecan Hydrochloride, Therapeutic Conventional Surgery
- First posted
- 2003-01-27
- Last updated
- 2019-04-16
- Other registries' IDs
- isrctn:ISRCTN41636183
- Results first posted
- 2016-04-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Up to 9 years | Proportion of participants whose overall survival exceeded 5 years. |
| Primary | Progression-free Survival | From the date of enrollment to first progression or death or last contact, if alive and progression free. | Median duration in months of progression free survival. |
| Secondary | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Up to 9 years |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Up to 9 years | All enrolled participants. | Proportion of participants | NUMBER |
| PRIMARY | Progression-free Survival | From the date of enrollment to first progression or death or last contact, if alive and progression free. | months | MEDIAN | |
| SECONDARY | Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 | Up to 9 years | Eligible and treated participants | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group140
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Carbo/Taxol | 0.35 | Proportion of participants | ||
| Overall Survival | Carbo/Taxol/Gemcitabine | 0.34 | Proportion of participants | ||
| Overall Survival | Carbo/Taxol/Doxil | 0.39 | Proportion of participants | ||
| Overall Survival | Carbo/Topotecan - Carbo/Taxol | 0.34 | Proportion of participants | ||
| Overall Survival | Carbo/Gemcitabine - Carbo/Taxol | 0.30 | Proportion of participants | ||
| Progression-free Survival | Carbo/Taxol | 16.0 | 95% Confidence Interval 14.9 to 17.2 | months | |
| Progression-free Survival | Carbo/Taxol/Gemcitabine | 16.3 | 95% Confidence Interval 15.1 to 17.7 | months | |
| Progression-free Survival | Carbo/Taxol/Doxil | 16.4 | 95% Confidence Interval 15.3 to 17.5 | months | |
| Progression-free Survival | Carbo/Topotecan - Carbo/Taxol | 15.4 | 95% Confidence Interval 14.7 to 16.3 | months | |
| Progression-free Survival | Carbo/Gemcitabine - Carbo/Taxol | 15.4 | 95% Confidence Interval 14.6 to 16.4 | months |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Carbo/Taxol | 864 | |
| Overall Study | STARTED | Carbo/Taxol/Gemcitabine | 864 | |
| Overall Study | STARTED | Carbo/Taxol/Doxil | 862 | |
| Overall Study | STARTED | Carbo/Topotecan - Carbo/Taxol | 861 | |
| Overall Study | STARTED | Carbo/Gemcitabine - Carbo/Taxol | 861 | |
| Overall Study | Initiated Treatment | Carbo/Taxol | 862 | |
| Overall Study | Initiated Treatment | Carbo/Taxol/Gemcitabine | 860 | |
| Overall Study | Initiated Treatment | Carbo/Taxol/Doxil | 854 | |
| Overall Study | Initiated Treatment | Carbo/Topotecan - Carbo/Taxol | 846 | |
| Overall Study | Initiated Treatment | Carbo/Gemcitabine - Carbo/Taxol | 851 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events635
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 | Leukopenia | Blood and lymphatic system disorders | Carbo/Taxol | 746 | 862 | |
| other | Leukopenia | Blood and lymphatic system disorders | Carbo/Taxol/Gemcitabine | 826 | 860 | |
| other | Leukopenia | Blood and lymphatic system disorders | Carbo/Taxol/Doxil | 806 | 854 | |
| other | Leukopenia | Blood and lymphatic system disorders | Carbo/Topotecan - Carbo/Taxol | 782 | 846 | |
| other | Leukopenia | Blood and lymphatic system disorders | Carbo/Gemcitabine - Carbo/Taxol | 800 | 851 | |
| other | Neutropenia | Blood and lymphatic system disorders | Carbo/Taxol | 821 | 862 | |
| other | Neutropenia | Blood and lymphatic system disorders | Carbo/Taxol/Gemcitabine | 838 | 860 | |
| other | Neutropenia | Blood and lymphatic system disorders | Carbo/Taxol/Doxil | 818 | 854 | |
| other | Neutropenia | Blood and lymphatic system disorders | Carbo/Topotecan - Carbo/Taxol | 830 | 846 | |
| other | Neutropenia | Blood and lymphatic system disorders | Carbo/Gemcitabine - Carbo/Taxol | 825 | 851 |
1 to 10 of 635Source ClinicalTrials.gov
See all 635 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Carbo/Taxol | ||
| Total, all-cause mortality | Carbo/Taxol/Gemcitabine | ||
| Total, all-cause mortality | Carbo/Taxol/Doxil | ||
| Total, all-cause mortality | Carbo/Topotecan - Carbo/Taxol | ||
| Total, all-cause mortality | Carbo/Gemcitabine - Carbo/Taxol | ||
| Total, other adverse events | Carbo/Taxol | 857 | 862 |
| Total, other adverse events | Carbo/Taxol/Gemcitabine | 856 | 860 |
| Total, other adverse events | Carbo/Taxol/Doxil | 852 | 854 |
| Total, other adverse events | Carbo/Topotecan - Carbo/Taxol | 843 | 846 |
| Total, other adverse events | Carbo/Gemcitabine - Carbo/Taxol | 849 | 851 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants1
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 |
|---|---|---|---|---|---|
| U10CA027469 | Gynecologic Oncology Group | DISAIA, PHILIP J. | GYNECOLOGIC ONCOLOGY GROUP | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00011986
GET https://conductscience.org/api/trials/v1/NCT00011986/results?page=2