CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 236 enrolled
Drug / intervention
carboplatin +5 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/NCT00980954
NCT00980954Phase 3Completed

Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With or Without Adjuvant Chemotherapy in High-Risk Patients With Early-Stage Cervical Carcinoma Following Radical Hysterectomy

Radiation Therapy Oncology Group·interventional·Posted Sep 21, 2009·Updated Dec 31, 2025

In Brief

A Phase 3 clinical trial evaluating carboplatin, cisplatin, and 4 other interventions for Cervical Cancer. Completed, enrolled 236 participants across 125 sites in 4 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without additional chemotherapy in treating cervical cancer. PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk early-stage cervical cancer after radical hysterectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer
CountriesCanada, Hong Kong, South Korea, United States

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 21, 2009
Enrollment StartSep 1, 2009
Primary CompletionDec 14, 2023
Study CompletionSep 4, 2025
TodayJul 2, 2026
Enrollment to primary: 14.3 yearsPosted 16.8 years ago

Interventions

carboplatindrug

Intravenously

cisplatindrug

Intravenously

paclitaxeldrug

Intravenously

intensity-modulated radiation therapyradiation

Daily fractions

standard external beam radiation therapyradiation

Daily fractions

Optional brachytherapy boostradiation

Low-dose rate (20-25 Gy single application) or high-dose rate (12-18 Gy 2-3 applications), dependent on external beam dose.