CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 926 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/NCT01414608
NCT01414608Phase 3Completed

A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial

GOG Foundation·interventional·Posted Aug 11, 2011·Updated Nov 7, 2022

In Brief

A Phase 3 clinical trial evaluating Brachytherapy, Carboplatin, and 4 other interventions for Cervical Adenocarcinoma and 7 related conditions. Completed, enrolled 926 participants across 326 sites in 5 countries.

Detailed Summary

This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with cervical cancer has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of \[cancer/tumor\] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. External radiation therapy uses high-energy x rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and external and internal radiation therapy together with carboplatin and paclitaxel kills more tumor cells.

Study Details

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 11, 2011
Enrollment StartJan 9, 2012
Primary CompletionJul 9, 2021
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 14.9 years ago

Interventions

Brachytherapyradiation

Undergo brachytherapy

Carboplatindrug

Given IV

Cisplatindrug

Given IV

External Beam Radiation Therapyradiation

Undergo external beam radiation therapy

Paclitaxeldrug

Given IV

Quality-of-Life Assessmentother

Ancillary studies