NCT05876130RecruitingNot Applicable
Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer: A Prospective Phase II Trial (POHIM_EM Trial)
Samsung Medical Center2 sites in 2 countries92 target enrollmentStarted: November 1, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Samsung Medical Center
- Enrollment
- 92
- Locations
- 2
- Primary Endpoint
- 5-year disease-free survival rate
Study Overview
Brief Summary
To investigate the non-inferiority of disease-free survival in women who received hypofractionated intensity-modulated whole pelvic radiation therapy (2.5 Gy x 16 fractions) after curative surgery for stage III endometrial cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •histologically confirmed endometrioid type endometrial cancer
- •completion of hysterectomy and surgical staging
- •pathologically confirmed FIGO stage III
- •ECOG performance status 0 or 1
- •adjuvant chemotherapy was done or planned
Exclusion Criteria
- •presence of distant metastasis
- •previous history of pelvic radiotherapy
- •severe and unstable medical condition
- •previous history of other carcinoma except for thyroid cancer, skin cancer, and endometrial cancer
Outcomes
Primary Outcomes
5-year disease-free survival rate
Time Frame: 5 years
disease-free survival rate after the time of surgery
Secondary Outcomes
- acute toxicities(3 months)
- late toxicities(5 years)
Investigators
Won Park
Professor
Samsung Medical Center
Study Sites (2)
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