Trial · NCT00954174
Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed, Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer
NCT00954174, Phase 3, Unknown, GOG Foundation; results first posted 2020-08-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed, Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer. Trials, record NCT00954174. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00954174
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed, Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer
- NCT number
- NCT00954174
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 637 participants, actual
- Lead sponsor
- GOG Foundation
- Conditions
Mixed Mesodermal (Mullerian) Tumor, Ovarian Carcinosarcoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Stage I Ovarian Cancer AJCC v6 and v7, Stage IA Fallopian Tube Cancer AJCC v6 and v7, Stage IA Ovarian Cancer AJCC v6 and v7, Stage IA Uterine Sarcoma AJCC v7, Stage IB Fallopian Tube Cancer AJCC v6 and v7, Stage IB Ovarian Cancer AJCC v6 and v7, Stage IB Uterine Sarcoma AJCC v7, Stage IC Fallopian Tube Cancer AJCC v6 and v7, Stage IC Ovarian Cancer AJCC v6 and v7, Stage IC Uterine Sarcoma AJCC v7, Stage II Ovarian Cancer AJCC v6 and v7, Stage IIA Fallopian Tube Cancer AJCC v6 and v7, Stage IIA Ovarian Cancer AJCC V6 and v7, Stage IIA Uterine Sarcoma AJCC v7, Stage IIB Fallopian Tube Cancer AJCC v6 and v7, Stage IIB Ovarian Cancer AJCC v6 and v7, Stage IIB Uterine Sarcoma AJCC v7, Stage IIC Fallopian Tube Cancer AJCC v6 and v7, Stage IIC Ovarian Cancer AJCC v6 and v7, Stage IIIA Fallopian Tube Cancer AJCC v7, Stage IIIA Ovarian Cancer AJCC v6 and v7, Stage IIIA Primary Peritoneal Cancer AJCC v7, Stage IIIA Uterine Sarcoma AJCC v7, Stage IIIB Fallopian Tube Cancer AJCC v7, Stage IIIB Ovarian Cancer AJCC v6 and v7, Stage IIIB Primary Peritoneal Cancer AJCC v7, Stage IIIB Uterine Sarcoma AJCC v7, Stage IIIC Fallopian Tube Cancer AJCC v7, Stage IIIC Ovarian Cancer AJCC v6 and v7, Stage IIIC Primary Peritoneal Cancer AJCC v7, Stage IIIC Uterine Sarcoma AJCC v7, Stage IV Fallopian Tube Cancer AJCC v6 and v7, Stage IV Ovarian Cancer AJCC v6 and v7, Stage IV Primary Peritoneal Cancer AJCC v7, Stage IVA Uterine Sarcoma AJCC v7, Stage IVB Uterine Sarcoma AJCC v7, Uterine Carcinosarcoma
- Interventions
- Carboplatin, Ifosfamide, Paclitaxel, Quality-of-Life Assessment
- First posted
- 2009-08-07
- Last updated
- 2021-09-30
- Results first posted
- 2020-08-10
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 115 months. | Measured in months from randomization to last contact or death. Primary analysis was restricted to the eligible uterine carcinosarcoma cohort. |
| Secondary | Duration of Progression-free Survival | Approximately 9 years and 7 months | Measured in months from randomization to last contact or the earlier of the date of progression or death. |
| Secondary | Incidence of Adverse Events as Assessed by CTCAE Version 3.0 | Patients were assessed for adverse events during active protocol treatment and up to 30 days after the last cycle of treatment on the protocol. | Maximum grade experienced among all treated and eligible patients. The grades are described by severity. Grade 1 is the lowest (most mild) and Grade 5 being death (most severe). Adverse events were analyzed across cohorts since disease site was considered independent of AEs. |
| Secondary | Patient-Reported Quality of Life (QOL) - Baseline | Baseline - Prior to study treatment | Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life. |
| Secondary | Patient Reported Quality of Life (QOL) - Post Baseline | Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1. | Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life. |
| Secondary | Patient Reported Peripheral Neuropathy Symptoms - Baseline | Baseline (Pre cycle 1) | Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). . The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life. |
| Secondary | Patient-reported Peripheral Neuropathy Symptoms - Post Baseline | Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1 | Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms.Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 115 months. | All eligible patients | months | MEDIAN |
| SECONDARY | Duration of Progression-free Survival | Approximately 9 years and 7 months | All eligible patients | months | MEDIAN |
| SECONDARY | Incidence of Adverse Events as Assessed by CTCAE Version 3.0 | Patients were assessed for adverse events during active protocol treatment and up to 30 days after the last cycle of treatment on the protocol. | Treated and Eligible subjects. Adverse events were analyzed across cohorts since disease site was considered independent of AEs. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient-Reported Quality of Life (QOL) - Baseline | Baseline - Prior to study treatment | Patients who provided baseline assessments. | units on a scale (time point) | MEAN |
| SECONDARY | Patient Reported Quality of Life (QOL) - Post Baseline | Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1. | Provided baseline and ≥ 1 follow-up assessments | units on a scale (time point) | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Reported Peripheral Neuropathy Symptoms - Baseline | Baseline (Pre cycle 1) | Subjects who provided baseline assessment | units on a scale-baseline | MEAN |
| SECONDARY | Patient-reported Peripheral Neuropathy Symptoms - Post Baseline | Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1 | Provided baseline and ≥ 1 follow-up assessments | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Regimen I- Uterine Carcinsarcoma Subjects | 37.3 | 95% Confidence Interval 25.7 to 49.0 | months | |
| Overall Survival | Regimen II - Uterine Carcinsarcoma Subjects | 29 | 95% Confidence Interval 21.9 to 43.1 | months | |
| Duration of Progression-free Survival | Regimen I - Uterine Carcinsarcoma Subjects | 16.3 | 95% Confidence Interval 13.0 to 18.9 | months | |
| Duration of Progression-free Survival | Regimen II - Uterine Carcinsarcoma Subjects | 11.7 | 95% Confidence Interval 10.1 to 17.3 | months | |
| Duration of Progression-free Survival | Regimen III - Non-uterine Carcinsarcoma Subjects | 14.6 | 95% Confidence Interval 8.1 to 16.4 | months | |
| Duration of Progression-free Survival | Regimen IV - Non-uterine Carcinsarcoma Subjects | 10.3 | 95% Confidence Interval 8.5 to 19.0 | months | |
| Incidence of Adverse Events as Assessed by CTCAE Version 3.0 | Regimen I - Uterine and Non-Uterine Subjects | Grade 1 | 3 | Participants | |
| Incidence of Adverse Events as Assessed by CTCAE Version 3.0 | Regimen II - All Uterine and Non-Uterine Subjects | Grade 1 | 3 | Participants | |
| Incidence of Adverse Events as Assessed by CTCAE Version 3.0 | Regimen I - Uterine and Non-Uterine Subjects | Grade 2 | 22 | Participants | |
| Incidence of Adverse Events as Assessed by CTCAE Version 3.0 | Regimen II - All Uterine and Non-Uterine Subjects | Grade 2 | 80 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regimen I - Uterine Carcinsarcoma Subjects | 268 | |
| Overall Study | STARTED | Regimen II - Uterine Carcinsarcoma Subjects | 268 | |
| Overall Study | STARTED | Regimen III - Non-uterine Carcinsarcoma Subjects | 51 | |
| Overall Study | STARTED | Regimen IV - Non-uterine Carcinsarcoma Subjects | 50 | |
| Overall Study | COMPLETED | Regimen I - Uterine Carcinsarcoma Subjects | 142 | |
| Overall Study | COMPLETED | Regimen II - Uterine Carcinsarcoma Subjects | 145 | |
| Overall Study | COMPLETED | Regimen III - Non-uterine Carcinsarcoma Subjects | 27 | |
| Overall Study | COMPLETED | Regimen IV - Non-uterine Carcinsarcoma Subjects | 25 | |
| Overall Study | NOT COMPLETED | Regimen I - Uterine Carcinsarcoma Subjects | 126 | |
| Overall Study | NOT COMPLETED | Regimen II - Uterine Carcinsarcoma Subjects | 123 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events744
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 | Allergic Reaction/Hypersensitivity | Immune system disorders | Regimen I - Uterine and Non-uterine Carcinosarcoma | 19 | 268 | |
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects | 11 | 247 | |
| other | Rhinitis | Immune system disorders | Regimen I - Uterine and Non-uterine Carcinosarcoma | 6 | 268 | |
| other | Rhinitis | Immune system disorders | Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects | 12 | 247 | |
| other | Auditory/Ear - Other | Ear and labyrinth disorders | Regimen I - Uterine and Non-uterine Carcinosarcoma | 1 | 268 | |
| other | Auditory/Ear - Other | Ear and labyrinth disorders | Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects | 2 | 247 | |
| other | Hearing (Without Monitoring Program) | Ear and labyrinth disorders | Regimen I - Uterine and Non-uterine Carcinosarcoma | 4 | 268 | |
| other | Hearing (Without Monitoring Program) | Ear and labyrinth disorders | Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects | 0 | 247 | |
| other | Tinnitus | Ear and labyrinth disorders | Regimen I - Uterine and Non-uterine Carcinosarcoma | 8 | 268 | |
| other | Tinnitus | Ear and labyrinth disorders | Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects | 4 | 247 |
1 to 10 of 744Source ClinicalTrials.gov
See all 744 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regimen I - Uterine and Non-uterine Carcinosarcoma | 160 | 272 |
| Total, all-cause mortality | Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects | 160 | 267 |
| Total, other adverse events | Regimen I - Uterine and Non-uterine Carcinosarcoma | 268 | 268 |
| Total, other adverse events | Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects | 244 | 247 |
| Total, serious adverse events | Regimen I - Uterine and Non-uterine Carcinosarcoma | 80 | 268 |
| Total, serious adverse events | Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects | 68 | 247 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35007153 | DERIVED |
Source PubMed
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA027469 | Gynecologic Oncology Group | DISAIA, PHILIP J. | GYNECOLOGIC ONCOLOGY GROUP | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Regimen I - Uterine and Non-uterine Carcinosarcoma vs Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects: deaths from any cause | Trial comparisons |
| Regimen I - Uterine and Non-uterine Carcinosarcoma vs Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects: 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/NCT00954174
GET https://conductscience.org/api/trials/v1/NCT00954174/results?page=2