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Trial Title:
Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer
NCT ID:
NCT05876130
Condition:
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Conditions: Keywords:
radiation therapy
hypofractionation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
hypofractionated IMRT (2.5 Gy x 16 fractions)
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
POHIM_EM
Description:
hypofractionated intensity-modulated radiation therapy (2.5 Gy/fraction, 16 fractions)
Arm group label:
POHIM_EM
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.
Criteria for 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
Gender:
Female
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Won Park
Email:
wonro.park@samsung.com
Start date:
November 1, 2022
Completion date:
December 31, 2031
Lead sponsor:
Agency:
Samsung Medical Center
Agency class:
Other
Source:
Samsung Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05876130