External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer (PORTEC-2)
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.
|Endometrial Cancer||Radiation: External Beam Radiation Therapy Radiation: Vaginal Brachytherapy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||PORTEC-2, Postoperative Radiation Therapy for Endometrial Carcinoma - A Multicenter Randomised Phase III Trial Comparing External Beam Radiation and Vaginal Brachytherapy|
- Rate of vaginal relapse [ Time Frame: 5 years ]
- Rate of distant metastases [ Time Frame: 5 years ]
- Overall survival [ Time Frame: 5 years ]
- Adverse effects [ Time Frame: 5 years ]
- health-related quality of life [ Time Frame: 5 years ]
- Pelvic relapse [ Time Frame: 5 years ]
|Study Start Date:||May 2002|
|Study Completion Date:||April 2016|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Active Comparator: External Beam Radiation Therapy
Postoperative pelvic radiotherapy
Radiation: External Beam Radiation Therapy
Other Name: pelvic radiotherapy
Experimental: Vaginal Brachytherapy
Postoperative vaginal brachytherapy
Radiation: Vaginal Brachytherapy
Other Name: internal radiation
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376844
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 RC|
|Study Chair:||Carien L. Creutzberg, MD, PhD||Leiden University Medical Center|