External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I End… (NCT00376844) | Clinical Trial Compass
CompletedPhase 3
External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer
Netherlands427 participantsStarted 2002-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.