External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer

Phase 3

Completed

• Conditions: Endometrial Cancer
• Interventions: Radiation: External Beam Radiation Therapy; Radiation: Vaginal Brachytherapy

• Registration Number: NCT00376844
• Lead Sponsor: Leiden University

Brief Summary

RATIONALE: External-beam 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. Giving external-beam radiation therapy or implant radiation therapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether radiation therapy is more effective than observation when given after surgery in treating stage I endometrial cancer.

PURPOSE: This randomized phase III trial is studying external-beam radiation therapy or implant radiation therapy to see how well they work compared with observation in treating patients who have undergone surgery for stage I endometrial cancer.

Detailed Description

OBJECTIVES:

* Compare the rate of 5-year locoregional relapse in patients undergoing external-beam radiotherapy or vaginal brachytherapy vs observation only after surgery for stage I endometrial cancer.

* Compare 5-year rate of distant metastases in these patients.

* Determine overall survival rate in these patients.

* Determine prognostic factors for relapse and morbidity.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo either vaginal brachytherapy or external-beam radiotherapy.

* Arm II: Patients are observed and undergo no further treatment. After completion of study treatment, patients are followed for approximately 83 days.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2006-09-13
• Study First Submitted QC: 2006-09-13
• Study First Posted: 2006-09-15
• Primary Completion: 2009-05
• Study Completion: 2016-04
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 427

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External Beam Radiation Therapy	External Beam Radiation Therapy	Postoperative pelvic radiotherapy
Vaginal Brachytherapy	Vaginal Brachytherapy	Postoperative vaginal brachytherapy

Primary Outcome Measures

Name	Time	Method
Vaginal relapse	5 years	total vaginal relapse and vaginal relapse as first failure

Secondary Outcome Measures

Name	Time	Method
Rate of distant metastases	5 years	total distant relapse and distant relapse as first failure
Overall survival	5 years	all-cause survival (and cancer-related survival)
Adverse effects	5 years	Types and severity graded according to EORTC-RTOG grading system
Health-related quality of life	5 years	Cancer-specific quality of life (EORTC QLQ C-30); patient reported symptoms
Pelvic relapse	5 years	total pelvic relapse and pelvic relapse as first failure

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands