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A Study of Short-course Hypofractionated Online-adaptive Radiotherapy for the Post-operative Treatment of Endometrial Cancer: Tolerability and Feasibility

RecruitingNAAges 18 Years - anyFemaleRoyal Marsden NHS Foundation Trust
NCT07675733 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to assess the safety and feasibility of using a new form of radiotherapy technology, known as CT online-adaptive radiotherapy, to reduce the number of treatment sessions required in post-operative radiotherapy for patients with endometrial cancer, from 25 sessions over 5 weeks to 5 sessions over a week and a half. The main questions it seeks to answer are: * If it is safe to deliver the radiotherapy in a smaller number of treatment sessions with a larger dose per session by utilising the CT online-adaptive technology * If it is feasible for this treatment to be delivered using the CT online-adaptive technology in a clinical trial All participants who enrol in the study would be offered the trial treatment of the radiotherapy being delivered in 5 sessions. Any potential participants who are subsequently found to be ineligible during the radiotherapy pl

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📋 Eligibility rules (as published)
Inclusion criteria 1. Histologically confirmed endometrial carcinoma - inclusive of endometrioid adenocarcinoma, carcinosarcoma, clear cell carcinoma, serous carcinoma, dedifferentiated carcinoma, mucinous carcinoma, mixed carcinoma 2. Age greater than 18 years old 3. Disease fully resected at time of surgery 4. Indication for post-operative external beam radiotherapy: high-intermediate risk and high-risk disease (ESGO-ESTRO-ESP guideline), or at the discretion of treating Clinical Oncologist 5. If adjuvant systemic chemotherapy is indicated, participants will still be eligible for trial participation, provided there is a minimum 3-week gap between completing chemotherapy and beginning external beam radiotherapy 6. If adjuvant vaginal vault brachytherapy boost is indicated, participants will still be eligible for trial participation, with a minimum gap of 1 day from completion of external beam radiotherapy to first fraction of brachytherapy 7. WHO Performance Status 0 - 2 8. Informed written consent Exclusion criteria 1. Previous pelvic radiotherapy 2. Contraindication to receiving external beam radiotherapy 3. Residual disease identified on post-operative imaging 4. FIGO 2023 Stage 3C2 disease requiring extended para-aortic treatment field 5. Hip prostheses or other metal work within the imaging field which would produce significant imaging artifact 6. Indication for adjuvant concurrent chemo-radiotherapy
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What it tests

  • Hypofractionated CT online adaptive radiotherapy (CT-OART) with dose of 30 Gray in 5 fractions, over one and a half weeks
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Where

1 site
The Royal Marsden Hospital - Sutton
Sutton, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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