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Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer

Sponsor
Samsung Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05876130
Collaborator
(none)
92
Enrollment
1
Location
1
Arm
110
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: POHIM_EM
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
92 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
hypofractionated IMRT (2.5 Gy x 16 fractions)hypofractionated IMRT (2.5 Gy x 16 fractions)
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer: A Prospective Phase II Trial (POHIM_EM Trial)
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2031
Anticipated Study Completion Date :
Dec 31, 2031

Arms and Interventions

Arm Intervention/Treatment
Experimental: POHIM_EM

adjuvant hypofractionated IMRT for endometrial cancer

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

Outcome Measures

Primary Outcome Measures

  1. 5-year disease-free survival rate [5 years]

    disease-free survival rate after the time of surgery

Secondary Outcome Measures

  1. acute toxicities [3 months]

    acute toxicities within 3 months according to CTCAE v5.0

  2. late toxicities [5 years]

    late toxicities according to CTCAE v5.0

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Korea, Republic of

Sponsors and Collaborators

  • Samsung Medical Center

Investigators

  • Principal Investigator: Won Park, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Won Park, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT05876130
Other Study ID Numbers:
  • 2022-09-123
First Posted:
May 25, 2023
Last Update Posted:
May 25, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Won Park, Professor, Samsung Medical Center
radiation therapy
hypofractionation
Additional relevant MeSH terms:
Endometrial Neoplasms

Study Results

No Results Posted as of May 25, 2023