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Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer

Primary Purpose

Endometrial Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
POHIM_EM
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring radiation therapy, hypofractionation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

POHIM_EM

Arm Description

adjuvant hypofractionated IMRT for endometrial cancer

Outcomes

Primary Outcome Measures

5-year disease-free survival rate
disease-free survival rate after the time of surgery

Secondary Outcome Measures

acute toxicities
acute toxicities within 3 months according to CTCAE v5.0
late toxicities
late toxicities according to CTCAE v5.0

Full Information

First Posted
May 16, 2023
Last Updated
May 16, 2023
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05876130
Brief Title
Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer
Official Title
Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer: A Prospective Phase II Trial (POHIM_EM Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 31, 2031 (Anticipated)
Study Completion Date
December 31, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
radiation therapy, hypofractionation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
hypofractionated IMRT (2.5 Gy x 16 fractions)
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
POHIM_EM
Arm Type
Experimental
Arm Description
adjuvant hypofractionated IMRT for endometrial cancer
Intervention Type
Radiation
Intervention Name(s)
POHIM_EM
Intervention Description
hypofractionated intensity-modulated radiation therapy (2.5 Gy/fraction, 16 fractions)
Primary Outcome Measure Information:
Title
5-year disease-free survival rate
Description
disease-free survival rate after the time of surgery
Time Frame
5 years
Secondary Outcome Measure Information:
Title
acute toxicities
Description
acute toxicities within 3 months according to CTCAE v5.0
Time Frame
3 months
Title
late toxicities
Description
late toxicities according to CTCAE v5.0
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Won Park
Phone
+82-2-3410-2612
Email
wonro.park@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Won Kyung Cho
Email
wklove.cho@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Park
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Park
Email
wonro.park@samsung.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer

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