External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer — PORTEC-2  

Endometrial Cancer Clinical Trial

Official title: PORTEC-2, Postoperative Radiation Therapy for Endometrial Carcinoma - A Multicenter Randomised Phase III Trial Comparing External Beam Radiation and Vaginal Brachytherapy

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

• NCT number: NCT00376844
• Study type: Interventional
• Source: Leiden University Medical Center
• Status: Completed
• Phase: Phase 3
• Start date: May 2002
• Completion date: April 2016