Clinical Research Directory
Browse clinical research sites, groups, and studies.
PErsonalized TReatment for Endometrial Carcinoma
Sponsor: University of Helsinki
Summary
The goal of this clinical trial is to compare the efficacy of adjuvant therapies in women with stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma. Specifically, the invesigators want to compare: * Chemotherapy vs. chemoradiotherapy in p53 abn subtype and nonendometrioid carcinomas. * Vaginal brachytherapy vs. whole pelvic radiotherapy in the MMR-D molecular subgroup. * Vaginal brachytherapy vs. whole pelvic radiotherapy in the NSMP molecular subgroup.
Key Details
Gender
FEMALE
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2022-02-08
Completion Date
2028-12-31
Last Updated
2024-12-06
Healthy Volunteers
No
Conditions
Interventions
Comparison of chemotherapy vs. chemoradiotherapy
Chemotherapy (paclitaxel-carboplatin) vs. chemoradiotherapy (paclitaxel-carboplatin followed by whole pelvic radiotherapy) Patients assigned to chemotherapy receive paclitaxel (175 mg/m2) and carboplatin (area under curve, 5) every 3 weeks for 6 cycles. The pelvic radiotherapy dose is 45 to 50.4 Gy over 5 to 6 weeks (1.8 Gy per day for 25 to 28 fractions).
Comparison of VBT vs. WPRT
Vaginal brachytherapy vs. whole pelvic radiotherapy Patients randomized to vaginal brachytherapy receive cuff brachytherapy at 21 Gy in 3 fractions of 7 Gy at 0.5 cm depth. The pelvic radiotherapy dose is 45 to 50.4 Gy over 5 to 6 weeks (1.8 Gy per day for 25 to 28 fractions).
Locations (1)
Helsinki University Hospital
Helsinki, Finland