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NCT05876130 Clinical Trial

Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:
Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer: A Prospective Phase II Trial (POHIM_EM Trial)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05876130
Other study ID # 2022-09-123
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date December 31, 2031

Study information
Verified date June 2024
Source Samsung Medical Center
Contact Won Park
Phone +82-2-3410-2612
Email wonro.park@samsung.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 92
Est. completion date December 31, 2031
Est. primary completion date December 31, 2031
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• POHIM_EM
hypofractionated intensity-modulated radiation therapy (2.5 Gy/fraction, 16 fractions)

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 5-year disease-free survival rate disease-free survival rate after the time of surgery 5 years
Secondary acute toxicities acute toxicities within 3 months according to CTCAE v5.0 3 months
Secondary late toxicities late toxicities according to CTCAE v5.0 5 years
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