Status:
COMPLETED
External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer
Lead Sponsor:
Leiden University
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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. Gi...
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 canc...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
427 Patients enrolled
Trial Details
Trial ID
NCT00376844
Start Date
May 1 2002
End Date
April 1 2016
Last Update
April 12 2022
Active Locations (1)
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1
Leiden University Medical Center
Leiden, Netherlands, 2300 RC