Postoperative Hypofractionated Intensity-modulated Radiot... | NCT05876130

Studies
Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer

NCT05876130

Sponsor

Samsung Medical Center

Status

Recruiting

Last Update Posted

Jun 12, 2024Actual

Enrollment

92Estimated

Phase

Not Applicable

Conditions

Endometrial Cancer

Interventions

POHIM_EM

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2022Actual

Primary Completion Date

Dec 31, 2031Estimated

Completion Date

Dec 31, 2031Estimated

First Submitted Date

May 16, 2023

First Submission Date that Met QC Criteria

May 16, 2023

First Posted Date

May 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2024

Last Update Posted Date

Jun 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
POHIM_EM	Experimental	adjuvant hypofractionated IMRT for endometrial cancer	Radiation: POHIM_EM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
POHIM_EM	Radiation	hypofractionated intensity-modulated radiation therapy (2.5 Gy/fraction, 16 fractions)	POHIM_EM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
5-year disease-free survival rate	disease-free survival rate after the time of surgery	5 years

Secondary Outcomes

Measure	Description	Time Frame
acute toxicities	acute toxicities within 3 months according to CTCAE v5.0	3 months
late toxicities	late toxicities according to CTCAE v5.0

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Won Park	Contact	+82-2-3410-2612		wonro.park@samsung.com
Won Kyung Cho	Contact			wklove.cho@samsung.com

Overall Officials

Name	Affiliation	Role
Won Park	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016889	Endometrial Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided