RecruitingNot ApplicableNCT05655260

PErsonalized TReatment for Endometrial Carcinoma

Sponsor

University of Helsinki

Enrollment

300 participants

Start Date

Feb 8, 2022

Study Type

INTERVENTIONAL

Conditions

Endometrial Adenocarcinoma

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

Sex: FEMALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether personalizing the treatment plan — including the type, sequence, and combination of chemotherapy and radiation — for people with intermediate- to high-risk endometrial (uterine) cancer improves outcomes compared to standard treatment. **You may be eligible if...** - You are between 18 and 100 years old - You have been diagnosed with Stage I or II endometrial cancer classified as high-intermediate or high risk based on its molecular features - Your overall health is adequate (WHO performance status 0–2) - You are starting treatment shortly after surgery **You may NOT be eligible if...** - You have uterine sarcoma (a different type of uterine cancer) - You have had another cancer in the last 5 years - You have previously had pelvic radiation - Too much time has passed since surgery before starting treatment (more than 30 days for chemo, or more than 8 weeks for radiation) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERComparison 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).

OTHERComparison 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).