Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer

Not Applicable

Recruiting

• Conditions: Endometrial Cancer

• Registration Number: NCT05876130
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12
• Primary Completion: 2031-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 92

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
5-year disease-free survival rate	5 years	disease-free survival rate after the time of surgery

Secondary Outcome Measures

Name	Time	Method
acute toxicities	3 months	acute toxicities within 3 months according to CTCAE v5.0
late toxicities	5 years	late toxicities according to CTCAE v5.0

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of