Trial · NCT00942357
Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer
NCT00942357, Phase 3, Unknown, Gynecologic Oncology Group; results first posted 2018-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer. Trials, record NCT00942357. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00942357
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer
- NCT number
- NCT00942357
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 813 participants, actual
- Lead sponsor
- Gynecologic Oncology Group
- Conditions
Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Stage IA Uterine Corpus Cancer AJCC v7, Stage IB Uterine Corpus Cancer AJCC v7, Stage II Uterine Corpus Cancer AJCC v7, Stage IIIA Uterine Corpus Cancer AJCC v7, Stage IIIB Uterine Corpus Cancer AJCC v7, Stage IIIC Uterine Corpus Cancer AJCC v7, Stage IVA Uterine Corpus Cancer AJCC v7
- Interventions
- Carboplatin, Cisplatin, Internal Radiation Therapy, Paclitaxel, Quality-of-Life Assessment, Radiation Therapy
- First posted
- 2009-07-20
- Last updated
- 2021-10-19
- Results first posted
- 2018-12-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Recurrence, Progression or Death | Disease was to be assessed at baseline, end of treatment and every 6 months for two years, and annually up to 5 years. | Number of participants enrolled with recurrence or progression of disease or death up to date of last contact. Progression is 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. |
| Secondary | Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0 | Assessed throughout the treatment period and for 21-30 days after discontinuation of treatment | The maximum grade of all treatment emergent adverse events without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death. |
| Secondary | Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0 | Assessed every 6 months for 3 years | The maximum grade of Adverse events reported during follow-up until progression of disease, a change of therapy or otherwise off study for a maximum of 3 years without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death. |
| Secondary | Overall Survival | From entry into the study to death or the date of last contact, assessed up to 8 years | Independence between the two endpoints, RFS and survival, and randomized treatment will be assessed with a stratified logrank test for an intent-to-treat analysis of eligible patients. |
| Secondary | Patient-reported Peripheral Neuropathy Symptoms | Prior to study treatment (baseline), Arm 1: 1 week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatement, 70 weeks post the starting of study treatment | 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 4 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). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less peripheral neuropathy symptoms. |
| Secondary | Patient-reported Quality of Life (QOL) | Prior to study treatment (baseline), Arm 1: 1 Week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatment, 70 weeks post the starting of study treatment | Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). It is a scale for assessing general QOL of endometrial cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Endometrium Cancer subscale (16 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). According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The FACT-En TOI score is calculated as the sum of the subscale scores, ranges are 0-120 with a large score suggesting a better QOL. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Recurrence, Progression or Death | Disease was to be assessed at baseline, end of treatment and every 6 months for two years, and annually up to 5 years. | Number of recurrence, progression or death events in eligible and enrolled patients | participants | NUMBER |
| SECONDARY | Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0 | Assessed throughout the treatment period and for 21-30 days after discontinuation of treatment | Eligible and treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0 | Assessed every 6 months for 3 years | All eligible and treated patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | From entry into the study to death or the date of last contact, assessed up to 8 years | |||
| SECONDARY | Patient-reported Peripheral Neuropathy Symptoms | Prior to study treatment (baseline), Arm 1: 1 week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatement, 70 weeks post the starting of study treatment | Patients who provided baseline and \>= 1 follow-up assessment(s) | unit on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient-reported Quality of Life (QOL) | Prior to study treatment (baseline), Arm 1: 1 Week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatment, 70 weeks post the starting of study treatment | Patients who provided baseline and \>= 1 follow-up assessments | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Recurrence, Progression or Death | Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | 132 | participants | ||
| Number of Participants With Recurrence, Progression or Death | Arm II (Paclitaxel and Carboplatin) | 139 | participants | ||
| Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0 | Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | Grade 1 | 5 | Participants | |
| Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0 | Arm II (Paclitaxel and Carboplatin) | Grade 1 | 15 | Participants | |
| Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0 | Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | Grade 2 | 139 | Participants | |
| Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0 | Arm II (Paclitaxel and Carboplatin) | Grade 2 | 118 | Participants | |
| Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0 | Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | Grade 3 | 154 | Participants | |
| Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0 | Arm II (Paclitaxel and Carboplatin) | Grade 3 | 119 | Participants | |
| Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0 | Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | Grade 4 | 48 | Participants | |
| Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0 | Arm II (Paclitaxel and Carboplatin) | Grade 4 | 105 | Participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | 407 | |
| Overall Study | STARTED | Arm II (Paclitaxel and Carboplatin) | 406 | |
| Overall Study | COMPLETED | Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | 370 | |
| Overall Study | COMPLETED | Arm II (Paclitaxel and Carboplatin) | 366 | |
| Overall Study | NOT COMPLETED | Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | 37 | |
| Overall Study | NOT COMPLETED | Arm II (Paclitaxel and Carboplatin) | 40 |
Source ClinicalTrials.gov
Adverse events776
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 | Allergy/Immunology - Other | Immune system disorders | Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | 3 | 346 | |
| other | Allergy/Immunology - Other | Immune system disorders | Arm II (Paclitaxel and Carboplatin) | 2 | 361 | |
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | 15 | 346 | |
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Arm II (Paclitaxel and Carboplatin) | 28 | 361 | |
| other | Rhinitis | Immune system disorders | Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | 7 | 346 | |
| other | Rhinitis | Immune system disorders | Arm II (Paclitaxel and Carboplatin) | 15 | 361 | |
| other | Autoimmune Reaction | Immune system disorders | Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | 0 | 346 | |
| other | Autoimmune Reaction | Immune system disorders | Arm II (Paclitaxel and Carboplatin) | 1 | 361 | |
| other | Auditory/Ear - Other | Ear and labyrinth disorders | Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | 2 | 346 | |
| other | Auditory/Ear - Other | Ear and labyrinth disorders | Arm II (Paclitaxel and Carboplatin) | 2 | 361 |
1 to 10 of 776Source ClinicalTrials.gov
See all 776 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | 0 | 0 |
| Total, all-cause mortality | Arm II (Paclitaxel and Carboplatin) | 0 | 0 |
| Total, other adverse events | Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | 346 | 346 |
| Total, other adverse events | Arm II (Paclitaxel and Carboplatin) | 360 | 361 |
| Total, serious adverse events | Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) | 78 | 346 |
| Total, serious adverse events | Arm II (Paclitaxel and Carboplatin) | 61 | 361 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) vs Arm II (Paclitaxel and Carboplatin): Number of Participants With Recurrence, Progression or Death | Trial comparisons |
| Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin) vs Arm II (Paclitaxel and Carboplatin): 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/NCT00942357
GET https://conductscience.org/api/trials/v1/NCT00942357/results?page=2