Recruiting NCT05876130
Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: POHIM_EM.
- Who it may be relevant to
- Registry conditions: Endometrial Cancer. Basic parameters: 20 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer: A Prospective Phase II Trial (POHIM_EM Trial)
Overview
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.
Interventions
- Radiation POHIM_EM
hypofractionated intensity-modulated radiation therapy (2.5 Gy/fraction, 16 fractions)
Primary outcome measures
- 5-year disease-free survival rate [Time frame: 5 years]
Secondary outcome measures (2)
- acute toxicities [Time frame: 3 months]
- late toxicities [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT05876130 · 2022-09-123