NCT05876130

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
69mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Nov 2022Dec 2031

Study Start

First participant enrolled

November 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

9.2 years

First QC Date

May 16, 2023

Last Update Submit

June 11, 2024

Conditions

Endometrial Cancer

Keywords

radiation therapyhypofractionation

Outcome Measures

Primary Outcomes (1)

  • 5-year disease-free survival rate

    disease-free survival rate after the time of surgery

    5 years

Secondary Outcomes (2)

  • acute toxicities

    3 months

  • late toxicities

    5 years

Study Arms (1)

POHIM_EM

EXPERIMENTAL

adjuvant hypofractionated IMRT for endometrial cancer

Radiation: POHIM_EM

Interventions

POHIM_EMRADIATION

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

POHIM_EM

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Won Park

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Won Park

CONTACT

+82-2-3410-2612wonro.park@samsung.com

Won Kyung Cho

CONTACT

wklove.cho@samsung.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: hypofractionated IMRT (2.5 Gy x 16 fractions)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 25, 2023

Study Start

November 1, 2022

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2031

Last Updated

June 12, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)