CI

At a glance

ClinicalIndex Comparison Record
Phase 3Unknown· 601 enrolled
Drug / intervention
Carboplatin +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00807768
NCT00807768Phase 3Unknown

A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients With High Risk, Early Stage Endometrial Carcinoma

Gynecologic Oncology Group·interventional·Posted Dec 12, 2008·Updated Mar 20, 2019

In Brief

A Phase 3 clinical trial evaluating 3-Dimensional Conformal Radiation Therapy, Carboplatin, and 6 other interventions for Endometrial Clear Cell Adenocarcinoma and 6 related conditions. Targeting 601 participants across 540 sites in 2 countries.

Detailed Summary

This randomized phase III trial studies pelvic radiation therapy to see how well it works compared with vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with high-risk stage I or stage II endometrial cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether pelvic radiation therapy alone is more effective than vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with endometrial cancer.

Study Details

Timeline

Phase 3UnknownOverdue
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 12, 2008
Enrollment StartMar 23, 2009
Primary CompletionDec 29, 2014
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 17.6 years ago

Interventions

3-Dimensional Conformal Radiation Therapyradiation

Undergo pelvic radiation therapy

Carboplatindrug

Given IV

Intensity-Modulated Radiation Therapyradiation

Undergo pelvic radiation therapy

Internal Radiation Therapyradiation

Undergo vaginal cuff brachytherapy

Laboratory Biomarker Analysisother

Correlative studies

Paclitaxeldrug

Given IV

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies