CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 340 enrolled
Drug / intervention
Cisplatin +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/NCT01101451
NCT01101451Phase 3Completed

Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy (NCT #01101451)

GOG Foundation·interventional·Posted Apr 12, 2010·Updated May 23, 2025

In Brief

A Phase 3 clinical trial evaluating Cisplatin, External Beam Radiation Therapy, and 4 other interventions for Cervical Adenocarcinoma and 6 related conditions. Completed, enrolled 340 participants across 719 sites in 3 countries.

Detailed Summary

This randomized phase III trial studies radiation therapy with chemotherapy to see how well they work compared to radiation therapy alone in treating patients with stage I-IIA cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, 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 giving radiation therapy together with chemotherapy is more effective than radiation therapy alone in treating patients with cervical cancer.

Study Details

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 12, 2010
Enrollment StartApr 12, 2010
Primary CompletionJan 15, 2024
Study CompletionApr 2, 2024
TodayJul 2, 2026
Enrollment to primary: 13.8 yearsPosted 16.2 years ago

Interventions

Cisplatindrug

Given IV

External Beam Radiation Therapyradiation

Undergo radiotherapy

Intensity-Modulated Radiation Therapyradiation

Undergo radiotherapy

Laboratory Biomarker Analysisother

Correlative studies

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies