External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer (PORTEC-2)
|ClinicalTrials.gov Identifier: NCT00376844|
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : February 27, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Radiation: External Beam Radiation Therapy Radiation: Vaginal Brachytherapy||Phase 3|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||427 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Exterbal beam radiation therapy versus vaginal brachytherapy|
|Masking:||None (Open Label)|
|Official Title:||PORTEC-2, Postoperative Radiation Therapy for Endometrial Carcinoma - A Multicenter Randomised Phase III Trial Comparing External Beam Radiation and Vaginal Brachytherapy|
|Study Start Date :||May 2002|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||April 2016|
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
- Vaginal relapse [ Time Frame: 5 years ]total vaginal relapse and vaginal relapse as first failure
- Rate of distant metastases [ Time Frame: 5 years ]total distant relapse and distant relapse as first failure
- Overall survival [ Time Frame: 5 years ]all-cause survival (and cancer-related survival)
- Adverse effects [ Time Frame: 5 years ]Types and severity graded according to EORTC-RTOG grading system
- Health-related quality of life [ Time Frame: 5 years ]Cancer-specific quality of life (EORTC QLQ C-30); patient reported symptoms
- Pelvic relapse [ Time Frame: 5 years ]total pelvic relapse and pelvic relapse as first failure
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376844
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 RC|
|Study Chair:||Carien L. Creutzberg, MD, PhD||Leiden University Medical Center|