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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 9-month Progression Rate Post-randomization | 9 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. |
| Secondary | Progression Free Survival | During 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. |
| Secondary | Overall Survival | During the study with median follow-up of 33 months | Time from the day of randomization to death from any cause. |
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 | 9-month Progression Rate Post-randomization | 9 months | All randomized patients | Porportion of participants | NUMBER |
| SECONDARY | Progression Free Survival | During the study with median follow-up of 33 months | All patients randomized to the study | months | MEDIAN |
| SECONDARY | Overall Survival | During the study with median follow-up of 33 months | months | MEDIAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 9-month Progression Rate Post-randomization | Arm 1 | 0.386 | Porportion of participants | ||
| 9-month Progression Rate Post-randomization | Arm 2 | 0.347 | Porportion of participants | ||
| 9-month Progression Rate Post-randomization | Arm 3 | 0.245 | Porportion of participants | ||
| Progression Free Survival | IV Carboplatin + IV Paclitaxel | 11.3 | 95% Confidence Interval 8.8 to 14.7 | months | |
| Progression Free Survival | IP Cisplatin + IV/IP Paclitaxel | 12.7 | 95% Confidence Interval 9.7 to 18.0 | months | |
| Progression Free Survival | IP Carboplatin + IV/IP Paclitaxel | 12.5 | 95% Confidence Interval 10.8 to 15.0 | months | |
| Overall Survival | IV Carboplatin + IV Paclitaxel | 38.1 | 95% Confidence Interval 32.9 to 47.7 | months | |
| Overall Survival | IP Cisplatin + IV/IP Paclitaxel | 40.6 | 95% Confidence Interval 38.7 to 68.1 | months | |
| Overall Survival | IP Carboplatin + IV/IP Paclitaxel | 59.3 | 95% Confidence Interval 34.2 to 68.3 | months |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 | 101 | |
| Overall Study | STARTED | Arm 2 | 72 | |
| Overall Study | STARTED | Arm 3 | 102 | |
| Overall Study | COMPLETED | Arm 1 | 101 | |
| Overall Study | COMPLETED | Arm 2 | 72 | |
| Overall Study | COMPLETED | Arm 3 | 102 | |
| Overall Study | NOT COMPLETED | Arm 1 | 0 | |
| Overall Study | NOT COMPLETED | Arm 2 | 0 | |
| Overall Study | NOT COMPLETED | Arm 3 | 0 |
Source ClinicalTrials.gov
Adverse events234
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 | Febrile neutropenia | Blood and lymphatic system disorders | Arm 1 | 5 | 95 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm 2 | 1 | 67 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm 3 | 1 | 92 | |
| other | Palpitations | Cardiac disorders | Arm 1 | 6 | 95 | |
| other | Palpitations | Cardiac disorders | Arm 2 | 0 | 67 | |
| other | Palpitations | Cardiac disorders | Arm 3 | 1 | 92 | |
| other | Hearing impaired | Ear and labyrinth disorders | Arm 1 | 7 | 95 | |
| other | Hearing impaired | Ear and labyrinth disorders | Arm 2 | 3 | 67 | |
| other | Hearing impaired | Ear and labyrinth disorders | Arm 3 | 4 | 92 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm 1 | 5 | 95 |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 | 34 | 95 |
| Total, all-cause mortality | Arm 2 | 24 | 67 |
| Total, all-cause mortality | Arm 3 | 26 | 92 |
| Total, other adverse events | Arm 1 | 94 | 95 |
| Total, other adverse events | Arm 2 | 64 | 67 |
| Total, other adverse events | Arm 3 | 92 | 92 |
| Total, serious adverse events | Arm 1 | 7 | 95 |
| Total, serious adverse events | Arm 2 | 8 | 67 |
| Total, serious adverse events | Arm 3 | 6 | 92 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29186319 | RESULT |
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.
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