Trial · NCT00003644
Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer
NCT00003644, Phase 3, Completed, Gynecologic Oncology Group; results first posted 2019-04-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer. Trials, record NCT00003644. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00003644
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer
- NCT number
- NCT00003644
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 571 participants, actual
- Lead sponsor
- Gynecologic Oncology Group
- Conditions
- Ovarian Cancer
- Interventions
- carboplatin, paclitaxel
- First posted
- 2003-01-27
- Last updated
- 2019-06-04
- Results first posted
- 2019-04-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | Up to 5 years | The percent of participants with disease recurrence within 5 years |
| Primary | Overall Survival | up to 96 months | Number of deaths during study and follow up. |
| Primary | Number of Participants With Adverse Events Grade 3 or Greater | Throughout study treatment lasting up to 24 weeks | Toxicities, Grade 3 or greater (CTC version 2.0) by treatment arm for all treated participants |
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 | Progression-free Survival | Up to 5 years | Eligible and treated participants | percentage of participants | NUMBER |
| PRIMARY | Overall Survival | up to 96 months | All eligible and treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events Grade 3 or Greater | Throughout study treatment lasting up to 24 weeks | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | 20.4 | 95% Confidence Interval 15.9 to 25.9 | percentage of participants | |
| Progression-free Survival | Paclitaxel + Carboplatin Followed by Observation | 23.2 | 95% Confidence Interval 18.4 to 28.9 | percentage of participants | |
| Overall Survival | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | 44 | Participants | ||
| Overall Survival | Paclitaxel + Carboplatin Followed by Observation | 53 | Participants | ||
| Number of Participants With Adverse Events Grade 3 or Greater | Grade 3 & Above Toxicity Paclitaxel + Carboplatin x 24 Cycles | Leukopenia | 74 | Participants | |
| Number of Participants With Adverse Events Grade 3 or Greater | Grade 3 & Above Toxicity Paclitaxel + Carboplatin x 3 Cycles | Leukopenia | 86 | Participants | |
| Number of Participants With Adverse Events Grade 3 or Greater | Grade 3 & Above Toxicity Paclitaxel + Carboplatin x 24 Cycles | Thrombocytopenia | 12 | Participants | |
| Number of Participants With Adverse Events Grade 3 or Greater | Grade 3 & Above Toxicity Paclitaxel + Carboplatin x 3 Cycles | Thrombocytopenia | 16 | Participants | |
| Number of Participants With Adverse Events Grade 3 or Greater | Grade 3 & Above Toxicity Paclitaxel + Carboplatin x 24 Cycles | Neutropenia | 203 | Participants | |
| Number of Participants With Adverse Events Grade 3 or Greater | Grade 3 & Above Toxicity Paclitaxel + Carboplatin x 3 Cycles | Neutropenia | 196 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | 289 | |
| Overall Study | STARTED | Paclitaxel + Carboplatin Followed by Observation | 282 | |
| Overall Study | COMPLETED | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | 274 | |
| Overall Study | COMPLETED | Paclitaxel + Carboplatin Followed by Observation | 268 | |
| Overall Study | NOT COMPLETED | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | 15 | |
| Overall Study | NOT COMPLETED | Paclitaxel + Carboplatin Followed by Observation | 14 |
Source ClinicalTrials.gov
Adverse events78
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 | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | 247 | 274 | 247 |
| other | Leukopenia | Blood and lymphatic system disorders | Paclitaxel + Carboplatin Followed by Observation | 236 | 268 | 236 |
| other | Anema | Blood and lymphatic system disorders | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | 219 | 274 | 219 |
| other | Anema | Blood and lymphatic system disorders | Paclitaxel + Carboplatin Followed by Observation | 209 | 268 | 209 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | 122 | 274 | 122 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Paclitaxel + Carboplatin Followed by Observation | 109 | 268 | 109 |
| other | Neutropenia | Blood and lymphatic system disorders | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | 255 | 274 | 255 |
| other | Neutropenia | Blood and lymphatic system disorders | Paclitaxel + Carboplatin Followed by Observation | 247 | 268 | 247 |
| other | Other Hematologic | Blood and lymphatic system disorders | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | 13 | 274 | 13 |
| other | Other Hematologic | Blood and lymphatic system disorders | Paclitaxel + Carboplatin Followed by Observation | 13 | 268 | 13 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | 44 | 274 |
| Total, all-cause mortality | Paclitaxel + Carboplatin Followed by Observation | 53 | 268 |
| Total, other adverse events | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | 271 | 274 |
| Total, other adverse events | Paclitaxel + Carboplatin Followed by Observation | 265 | 268 |
| Total, serious adverse events | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | 7 | 274 |
| Total, serious adverse events | Paclitaxel + Carboplatin Followed by Observation | 5 | 268 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21529904 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel vs Paclitaxel + Carboplatin Followed by Observation: Overall Survival | Trial comparisons |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel vs Paclitaxel + Carboplatin Followed by Observation: deaths from any cause | Trial comparisons |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel vs Paclitaxel + Carboplatin Followed by Observation: serious adverse events | 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/NCT00003644
GET https://conductscience.org/api/trials/v1/NCT00003644/results?page=2