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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryOverall SurvivalUp to 9 yearsProportion of participants whose overall survival exceeded 5 years.
PrimaryProgression-free SurvivalFrom 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.
SecondaryNumber of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0Up to 9 years

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYOverall SurvivalUp to 9 yearsAll enrolled participants.Proportion of participantsNUMBER
PRIMARYProgression-free SurvivalFrom the date of enrollment to first progression or death or last contact, if alive and progression free.monthsMEDIAN
SECONDARYNumber of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0Up to 9 yearsEligible and treated participantsParticipantsCOUNT_OF_PARTICIPANTS

Results by group140

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Overall SurvivalCarbo/Taxol0.35Proportion of participants
Overall SurvivalCarbo/Taxol/Gemcitabine0.34Proportion of participants
Overall SurvivalCarbo/Taxol/Doxil0.39Proportion of participants
Overall SurvivalCarbo/Topotecan - Carbo/Taxol0.34Proportion of participants
Overall SurvivalCarbo/Gemcitabine - Carbo/Taxol0.30Proportion of participants
Progression-free SurvivalCarbo/Taxol16.095% Confidence Interval 14.9 to 17.2months
Progression-free SurvivalCarbo/Taxol/Gemcitabine16.395% Confidence Interval 15.1 to 17.7months
Progression-free SurvivalCarbo/Taxol/Doxil16.495% Confidence Interval 15.3 to 17.5months
Progression-free SurvivalCarbo/Topotecan - Carbo/Taxol15.495% Confidence Interval 14.7 to 16.3months
Progression-free SurvivalCarbo/Gemcitabine - Carbo/Taxol15.495% Confidence Interval 14.6 to 16.4months

Participant flow20

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDCarbo/Taxol864
Overall StudySTARTEDCarbo/Taxol/Gemcitabine864
Overall StudySTARTEDCarbo/Taxol/Doxil862
Overall StudySTARTEDCarbo/Topotecan - Carbo/Taxol861
Overall StudySTARTEDCarbo/Gemcitabine - Carbo/Taxol861
Overall StudyInitiated TreatmentCarbo/Taxol862
Overall StudyInitiated TreatmentCarbo/Taxol/Gemcitabine860
Overall StudyInitiated TreatmentCarbo/Taxol/Doxil854
Overall StudyInitiated TreatmentCarbo/Topotecan - Carbo/Taxol846
Overall StudyInitiated TreatmentCarbo/Gemcitabine - Carbo/Taxol851

Adverse events635

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherLeukopeniaBlood and lymphatic system disordersCarbo/Taxol746862
otherLeukopeniaBlood and lymphatic system disordersCarbo/Taxol/Gemcitabine826860
otherLeukopeniaBlood and lymphatic system disordersCarbo/Taxol/Doxil806854
otherLeukopeniaBlood and lymphatic system disordersCarbo/Topotecan - Carbo/Taxol782846
otherLeukopeniaBlood and lymphatic system disordersCarbo/Gemcitabine - Carbo/Taxol800851
otherNeutropeniaBlood and lymphatic system disordersCarbo/Taxol821862
otherNeutropeniaBlood and lymphatic system disordersCarbo/Taxol/Gemcitabine838860
otherNeutropeniaBlood and lymphatic system disordersCarbo/Taxol/Doxil818854
otherNeutropeniaBlood and lymphatic system disordersCarbo/Topotecan - Carbo/Taxol830846
otherNeutropeniaBlood and lymphatic system disordersCarbo/Gemcitabine - Carbo/Taxol825851

Adverse event totals15

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityCarbo/Taxol
Total, all-cause mortalityCarbo/Taxol/Gemcitabine
Total, all-cause mortalityCarbo/Taxol/Doxil
Total, all-cause mortalityCarbo/Topotecan - Carbo/Taxol
Total, all-cause mortalityCarbo/Gemcitabine - Carbo/Taxol
Total, other adverse eventsCarbo/Taxol857862
Total, other adverse eventsCarbo/Taxol/Gemcitabine856860
Total, other adverse eventsCarbo/Taxol/Doxil852854
Total, other adverse eventsCarbo/Topotecan - Carbo/Taxol843846
Total, other adverse eventsCarbo/Gemcitabine - Carbo/Taxol849851

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
23969788DERIVEDPubMed
24779680DERIVEDPubMed
30633128DERIVEDPubMed
37148580DERIVEDPubMed
37229879DERIVEDPubMed

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
U10CA027469Gynecologic Oncology GroupDISAIA, PHILIP J.GYNECOLOGIC ONCOLOGY GROUPNATIONAL CANCER INSTITUTE1985 to 2013

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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