Trial · NCT00807768
Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer
NCT00807768, Phase 3, Unknown, Gynecologic Oncology Group; results first posted 2018-04-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer. Trials, record NCT00807768. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00807768
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer
- NCT number
- NCT00807768
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 601 participants, actual
- Lead sponsor
- Gynecologic Oncology Group
- Conditions
- Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Fatigue, Neurotoxicity Syndrome, Obesity, Stage I Uterine Corpus Cancer AJCC v7, Stage II Uterine Corpus Cancer AJCC v7
- Interventions
3-Dimensional Conformal Radiation Therapy, Carboplatin, Intensity-Modulated Radiation Therapy, Internal Radiation Therapy, Laboratory Biomarker Analysis, Paclitaxel, Quality-of-Life Assessment, Questionnaire Administration
- First posted
- 2008-12-12
- Last updated
- 2019-03-20
- Results first posted
- 2018-04-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Recurrence or Death Events at Primary Analysis | Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated, assessed up to 10 years | Recurrence-Free Survival is the period from study entry until disease recurrence, death, or date of last contact |
| Secondary | Number of Participants With Death Events | Overall survival is measured from study enrollment for up to 10 years. | The number of death events is reported. Overall survival is reported by the number of deaths occurring while on study. |
| Secondary | Number of Participants With Sites of Recurrence | Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated thereafter, up to 10 years | Three competing risk analyses were carried out for three different types of recurrences: 1) any vaginal, 2) any pelvic or any PA nodes and 3) any distant. More than one type of recurrence can be counted for an individual patient. A death prior to a specific type of recurrence was considered a competing event. |
| Secondary | Patient Reported Fatigue | Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment | Patient reported fatigue as measured with the Functional Assessment of Chronic Illness Therapy- Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue contains 13 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 Fatigue 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 FACIT-Fatigue score ranges 0-52 with a large score suggests less fatigue. |
| Secondary | Patient-reported Neurotoxicity | Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment. | Patient reported neurotoxicity symptoms as 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 suggesting less neurotoxicity. |
| Secondary | Patient-reported Quality of Life | Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment | Patient reported quality of life as measured with the Treatment Outcome Index 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. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Endometrium Cancer subscale (16 items). Each item in the FACT-En TOI 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 FACT-En TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-En TOI items provide valid answers and all of the component subscales have valid scores. The FACT-En TOI score ranges 0-120 with a large score suggests better QOL |
| Other | Gene Expression Based Risk Score | Baseline |
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 | Number of Participants With Recurrence or Death Events at Primary Analysis | Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated, assessed up to 10 years | All enrolled patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Death Events | Overall survival is measured from study enrollment for up to 10 years. | All enrolled patients. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sites of Recurrence | Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated thereafter, up to 10 years | All enrolled patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Reported Fatigue | Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment | Provided baseline and \>= follow-up assessments | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient-reported Neurotoxicity | Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment. | Provided baseline and ≥ follow-up assessments | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient-reported Quality of Life | Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment | Provided baseline and \>= follow-up assessments | units on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Gene Expression Based Risk Score | Baseline |
Source ClinicalTrials.gov
Results by group40
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 or Death Events at Primary Analysis | Arm I (Pelvic Radiation Therapy) | 44 | Participants | ||
| Number of Participants With Recurrence or Death Events at Primary Analysis | Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 43 | Participants | ||
| Number of Participants With Death Events | Arm I (Pelvic Radiation Therapy) | 39 | Participants | ||
| Number of Participants With Death Events | Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 37 | Participants | ||
| Number of Participants With Sites of Recurrence | Arm I (Pelvic Radiation Therapy) | Vaginal recurrence | 6 | Participants | |
| Number of Participants With Sites of Recurrence | Arm II (Brachytherapy, Paclitaxel, Carboplatin) | Vaginal recurrence | 6 | Participants | |
| Number of Participants With Sites of Recurrence | Arm I (Pelvic Radiation Therapy) | Pelvic or PA node | 12 | Participants | |
| Number of Participants With Sites of Recurrence | Arm II (Brachytherapy, Paclitaxel, Carboplatin) | Pelvic or PA node | 25 | Participants | |
| Number of Participants With Sites of Recurrence | Arm I (Pelvic Radiation Therapy) | Distant recurrence | 47 | Participants | |
| Number of Participants With Sites of Recurrence | Arm II (Brachytherapy, Paclitaxel, Carboplatin) | Distant recurrence | 47 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 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 (Pelvic Radiation Therapy) | 301 | |
| Overall Study | STARTED | Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 300 | |
| Overall Study | COMPLETED | Arm I (Pelvic Radiation Therapy) | 301 | |
| Overall Study | COMPLETED | Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 300 | |
| Overall Study | NOT COMPLETED | Arm I (Pelvic Radiation Therapy) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 0 |
Source ClinicalTrials.gov
Adverse events506
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 | Arm I (Pelvic Radiation Therapy) | 1 | 283 | |
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 17 | 290 | |
| other | Rhinitis | Immune system disorders | Arm I (Pelvic Radiation Therapy) | 0 | 283 | |
| other | Rhinitis | Immune system disorders | Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 4 | 290 | |
| other | Hearing (Without Monitoring Program) | Ear and labyrinth disorders | Arm I (Pelvic Radiation Therapy) | 0 | 283 | |
| other | Hearing (Without Monitoring Program) | Ear and labyrinth disorders | Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 2 | 290 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm I (Pelvic Radiation Therapy) | 0 | 283 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 4 | 290 | |
| other | Neutrophils | Blood and lymphatic system disorders | Arm I (Pelvic Radiation Therapy) | 31 | 283 | |
| other | Neutrophils | Blood and lymphatic system disorders | Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 227 | 290 |
1 to 10 of 506Source ClinicalTrials.gov
See all 506 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Pelvic Radiation Therapy) | ||
| Total, all-cause mortality | Arm II (Brachytherapy, Paclitaxel, Carboplatin) | ||
| Total, other adverse events | Arm I (Pelvic Radiation Therapy) | 245 | 283 |
| Total, other adverse events | Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 284 | 290 |
| Total, serious adverse events | Arm I (Pelvic Radiation Therapy) | 9 | 283 |
| Total, serious adverse events | Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 32 | 290 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30995174 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Pelvic Radiation Therapy) vs Arm II (Brachytherapy, Paclitaxel, Carboplatin): Number of Participants With Recurrence or Death Events at Primary Analysis | Trial comparisons |
| Arm I (Pelvic Radiation Therapy) vs Arm II (Brachytherapy, Paclitaxel, Carboplatin): Number of Participants With Death Events | Trial comparisons |
| Arm I (Pelvic Radiation Therapy) vs Arm II (Brachytherapy, Paclitaxel, 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/NCT00807768
GET https://conductscience.org/api/trials/v1/NCT00807768/results?page=2