Endometrial Cancer
Conditions
Keywords
stage I endometrial carcinoma
Brief 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.
Detailed 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.
Interventions
RADIATIONExternal Beam Radiation Therapy
RADIATIONVaginal Brachytherapy
Sponsors
Dutch Cancer Society
Leiden University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Exterbal beam radiation therapy versus vaginal brachytherapy
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal relapse | 5 years | total vaginal relapse and vaginal relapse as first failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of distant metastases | 5 years | total distant relapse and distant relapse as first failure |
| Overall survival | 5 years | all-cause survival (and cancer-related survival) |
| Adverse effects | 5 years | Types and severity graded according to EORTC-RTOG grading system |
| Health-related quality of life | 5 years | Cancer-specific quality of life (EORTC QLQ C-30); patient reported symptoms |
| Pelvic relapse | 5 years | total pelvic relapse and pelvic relapse as first failure |
Countries
Netherlands
Outcome results
None listed