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Recruiting NCT05876130

Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer

No phase Interventional 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 →
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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗