A Phase 3 interventional study of External Beam Radiation Therapy and Vaginal Brachytherapy in Endometrial Cancer, sponsored by Leiden University. Completed at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-12.
Sponsored by Leiden University · Phase 3, Interventional, and Treatment
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.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's enrollment of 427 is above the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Leiden University is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis of FIGO 1988 stage I-IIA endometrial cancer, meeting 1 of the following criteria:
EXCLUSION CRITERIA:
Postoperative pelvic radiotherapy
Radiation: External Beam Radiation Therapy
Postoperative vaginal brachytherapy
Radiation: Vaginal Brachytherapy
Also known as: pelvic radiotherapy
Also known as: internal radiation
Vaginal relapse
total vaginal relapse and vaginal relapse as first failure
Time frame: 5 years
Rate of distant metastases
total distant relapse and distant relapse as first failure
Time frame: 5 years
Overall survival
all-cause survival (and cancer-related survival)
Time frame: 5 years
Adverse effects
Types and severity graded according to EORTC-RTOG grading system
Time frame: 5 years
Health-related quality of life
Cancer-specific quality of life (EORTC QLQ C-30); patient reported symptoms
Time frame: 5 years
Pelvic relapse
total pelvic relapse and pelvic relapse as first failure
Time frame: 5 years
Plan to share: Yes — After submission of a research plan and approval by the TMG data will be shared
Supporting information: Study protocol, Icf, Csr
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Leiden University