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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Radiation: External Beam Radiation Therapy
* Radiation: Vaginal Brachytherapy


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Diagnosis of FIGO 1988 stage I-IIA endometrial cancer, meeting 1 of the following criteria: Age ≥60, stage IC grade 1 or 2 with deep (≥ 50%) myometrial invasion Age ≥60, stage IB grade 2 or 3 (with < 50% myometrial invasion) Stage IIA, any age No grade 3 endometrial carcinoma with deep myometrial invasion Total abdominal hysterectomy and bilateral salpingo-oophorectomy required prior to randomisation WHO performance status 0-2 EXCLUSION CRITERIA: Serous or clear cell histology or uterine sarcoma staging lymphadenectomy interval between surgery and radiotherapy > 8 weeks history of previous malignant disease (except basal cell carcinoma of skin) previous radiotherapy, hormonal therapy or chemotherapy diagnosis of Chrohn's disease or ulcerative colitis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Exterbal beam radiation therapy versus vaginal brachytherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: External Beam Radiation Therapy<br>Postoperative pelvic radiotherapy | Radiation: External Beam Radiation Therapy<br> <br> * Other names: pelvic radiotherapy;|
| Experimental: Vaginal Brachytherapy<br>Postoperative vaginal brachytherapy | Radiation: Vaginal Brachytherapy<br> <br> * Other names: internal radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal relapse | total vaginal relapse and vaginal relapse as first failure | 5 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I endometrial carcinoma