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Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer

Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer: A Prospective Phase II Trial (POHIM_EM Trial)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05876130
Enrollment
92
Registered
2023-05-25
Start date
2022-11-01
Completion date
2031-12-31
Last updated
2024-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

radiation therapy, hypofractionation

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.

Interventions

RADIATIONPOHIM_EM

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

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

hypofractionated IMRT (2.5 Gy x 16 fractions)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
5-year disease-free survival rate5 yearsdisease-free survival rate after the time of surgery

Secondary

MeasureTime frameDescription
acute toxicities3 monthsacute toxicities within 3 months according to CTCAE v5.0
late toxicities5 yearslate toxicities according to CTCAE v5.0

Countries

South Korea

Contacts

Primary ContactWon Park
wonro.park@samsung.com+82-2-3410-2612
Backup ContactWon Kyung Cho
wklove.cho@samsung.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026