Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer

NCT ID: NCT05876130

Last Updated: 2024-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2031-12-31

Brief Summary

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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

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Conditions

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Endometrial Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

hypofractionated IMRT (2.5 Gy x 16 fractions)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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POHIM_EM

adjuvant hypofractionated IMRT for endometrial cancer

Group Type EXPERIMENTAL

POHIM_EM

Intervention Type RADIATION

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

Interventions

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POHIM_EM

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Won Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Won Park

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Won Park

Role: CONTACT

+82-2-3410-2612

Won Kyung Cho

Role: CONTACT

Facility Contacts

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Won Park

Role: primary

Other Identifiers

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2022-09-123

Identifier Type: -

Identifier Source: org_study_id

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