PErsonalized TReatment for Endometrial Carcinoma
University of Helsinki
300 participants
Feb 8, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Age 18 to 100 years
- WHO performance status 0 to 2
- Stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma
Exclusion Criteria6
- Age \<18 years or \>100 years
- WHO performance status \>2
- Uterine sarcoma
- A history of malignancy within 5 years
- Previous pelvic radiotherapy
- An interval of \>30 days between surgery and start of chemotherapy or \>8 weeks between surgery and start of radiotherapy (longer intervals may be permitted with investigator´s approval)
Interventions
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).
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)
View Full Details on ClinicalTrials.gov
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NCT05655260