External-Beam Radiation Therapy or Implant Radiation Therapy Compared With Observation in Treating Patients Who Have Undergone Surgery for Stage I Endometrial Cancer
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.
Other: clinical observation
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
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 locoregional relapse at 5 years [ Designated as safety issue: No ]
- Rate of distant metastases at 5 years [ Designated as safety issue: No ]
- Overall survival rate [ Designated as safety issue: No ]
- Prognostic factors for relapse and morbidity [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
- 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 104 patients will be accrued for this study.
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 RC|
|Study Chair:||Carien C. L. Creutzberg, MD, PhD||Leiden University Medical Center|