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Trial · NCT00993655

Intraperitoneal vs Intravenous Chemotherapy Following Neoadjuvant Chemotherapy in Ovarian Cancer

NCT00993655, Phase 2, Completed, Canadian Cancer Trials Group; results first posted 2017-08-10

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Intraperitoneal vs Intravenous Chemotherapy Following Neoadjuvant Chemotherapy in Ovarian Cancer. Trials, record NCT00993655. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00993655

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Intraperitoneal vs Intravenous Chemotherapy Following Neoadjuvant Chemotherapy in Ovarian Cancer
NCT number
NCT00993655
Status
Completed
Phases
Phase 2
Enrollment
275 participants, actual
Lead sponsor
Canadian Cancer Trials Group
Conditions
Fallopian Tube Cancer, Metastatic Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Interventions
carboplatin, cisplatin, paclitaxel
First posted
2009-10-12
Last updated
2023-08-28
Results first posted
2017-08-10

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primary9-month Progression Rate Post-randomization9 months
It is defined as proportion of patients who had progressed at or before 9 months after randomization, i.e., the time from the randomization to the date when the first observation of disease progression (earliest of the date when the first CA 125 meets progression definition and the date of first objective relapse or progression, 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, recorded) has been documented or when death due to any cause has been observed was less than or equal to 9 months.
SecondaryProgression Free SurvivalDuring the study with median follow-up of 33 months
Time from the day of randomization until the time when first observation of disease progression (earliest of the dates of first CA125 which meets progression definition and first objective relapse or progression 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, has been documented or when death due to any cause has been observed.
SecondaryOverall SurvivalDuring the study with median follow-up of 33 monthsTime from the day of randomization to death from any cause.

Outcomes3

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARY9-month Progression Rate Post-randomization9 monthsAll randomized patientsPorportion of participantsNUMBER
SECONDARYProgression Free SurvivalDuring the study with median follow-up of 33 monthsAll patients randomized to the studymonthsMEDIAN
SECONDARYOverall SurvivalDuring the study with median follow-up of 33 monthsmonthsMEDIAN

Results by group9

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

OutcomeGroupCategoryValueSpreadUnits
9-month Progression Rate Post-randomizationArm 10.386Porportion of participants
9-month Progression Rate Post-randomizationArm 20.347Porportion of participants
9-month Progression Rate Post-randomizationArm 30.245Porportion of participants
Progression Free SurvivalIV Carboplatin + IV Paclitaxel11.395% Confidence Interval 8.8 to 14.7months
Progression Free SurvivalIP Cisplatin + IV/IP Paclitaxel12.795% Confidence Interval 9.7 to 18.0months
Progression Free SurvivalIP Carboplatin + IV/IP Paclitaxel12.595% Confidence Interval 10.8 to 15.0months
Overall SurvivalIV Carboplatin + IV Paclitaxel38.195% Confidence Interval 32.9 to 47.7months
Overall SurvivalIP Cisplatin + IV/IP Paclitaxel40.695% Confidence Interval 38.7 to 68.1months
Overall SurvivalIP Carboplatin + IV/IP Paclitaxel59.395% Confidence Interval 34.2 to 68.3months

Participant flow9

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDArm 1101
Overall StudySTARTEDArm 272
Overall StudySTARTEDArm 3102
Overall StudyCOMPLETEDArm 1101
Overall StudyCOMPLETEDArm 272
Overall StudyCOMPLETEDArm 3102
Overall StudyNOT COMPLETEDArm 10
Overall StudyNOT COMPLETEDArm 20
Overall StudyNOT COMPLETEDArm 30

Adverse events234

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

TypeEventOrgan systemGroupAffectedAt riskEvents
otherFebrile neutropeniaBlood and lymphatic system disordersArm 1595
otherFebrile neutropeniaBlood and lymphatic system disordersArm 2167
otherFebrile neutropeniaBlood and lymphatic system disordersArm 3192
otherPalpitationsCardiac disordersArm 1695
otherPalpitationsCardiac disordersArm 2067
otherPalpitationsCardiac disordersArm 3192
otherHearing impairedEar and labyrinth disordersArm 1795
otherHearing impairedEar and labyrinth disordersArm 2367
otherHearing impairedEar and labyrinth disordersArm 3492
otherTinnitusEar and labyrinth disordersArm 1595

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityArm 13495
Total, all-cause mortalityArm 22467
Total, all-cause mortalityArm 32692
Total, other adverse eventsArm 19495
Total, other adverse eventsArm 26467
Total, other adverse eventsArm 39292
Total, serious adverse eventsArm 1795
Total, serious adverse eventsArm 2867
Total, serious adverse eventsArm 3692

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
29186319RESULT

Source PubMed

Grants0

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.

None in this release.

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/NCT00993655

GET https://conductscience.org/api/trials/v1/NCT00993655/events?page=2