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 planning process would be excluded from the trial treatment of a higher dose over 5 sessions, but would still be offered the CT online-adaptive technology over 25 sessions outside of the trial.
Participants would undergo the trial treatment with the radiotherapy being delivered in 5 sessions over a week and a half using the CT online-adaptive technology, with any issues during the treatment delivery recorded, and a questionnaire to complete at the end of treatment to see how the new technology was tolerated by participants.
Participants will have their side effects recorded by the trial team before, during and after their treatment for 2 years following the radiotherapy. During this time period participants will also be asked to complete patient questionnaires to assess their perception of side effects and their quality-of-life after undergoing the treatment. Participants will also have blood tests before, during and after the radiotherapy for 3 months to check for any potential problems with blood counts as a result of the trial treatment.
During the 2 years of follow-up after the radiotherapy, participants will also have assessments for if the cancer has returned, which will be completed by a combination of clinical examination, and CT scans.
Following completion of the 2 years of trial follow-up, participants would remain on general follow-up to assess for if the cancer has returned, or for any longer term side effects for up to 5 years after the treatment, but this follow-up will be outside of the trial without the request for ongoing completion of participant questionnaires.
Histologically confirmed endometrial carcinoma - inclusive of endometrioid adenocarcinoma, carcinosarcoma, clear cell carcinoma, serous carcinoma, dedifferentiated carcinoma, mucinous carcinoma, mixed carcinoma
Age greater than 18 years old
Disease fully resected at time of surgery
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
Previous pelvic radiotherapy
Contraindication to receiving external beam radiotherapy
Residual disease identified on post-operative imaging
FIGO 2023 Stage 3C2 disease requiring extended para-aortic treatment field
Single group
Hypofractionated CT online adaptive radiotherapy (CT-OART) with dose of 30 Gray in 5 fractions, over one and a half weeks
RadiationHypofractionated CT online adaptive radiotherapy (CT-OART) with dose of 30 Gray in 5 fractions, over one and a half weeks, for the post-operative treatment of endometrial cancer
Percentage of patients experiencing acute grade 3 or 4 gastrointestinal or genitourinary toxicity, attributable to radiotherapy
• Percentage of patients experiencing acute grade 3 or 4 gastrointestinal or genitourinary toxicity, attributable to radiotherapy, up to 12 weeks following radiotherapy (as assessed by National Cancer Institute Clinician graded Common Terminology Criteria for Adverse Events (CTCAE) 6.0)
Feasibility of a CT Online Adaptive workflow
Feasibility of a CT-online adaptive workflow, as assessed by: Patient-experience questionnaire at the end of radiotherapy (Likert scale 0 - 3 where 0 represents a negative response and 3 the most favourable response) , greater than 80% of scheduled CT-OART fractions delivered, Narrative of workflow delays and issues, Patient in room to out of room timing
Patient-reported acute GI and GU toxicity incidence, severity, and longitudinal change from baseline up to 12 weeks following radiotherapy
Patient-reported acute GI and GU toxicity incidence, severity, and longitudinal change from baseline up to 12 weeks following radiotherapy, as assessed by the Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE), on a 0 to 4 scale, where 0 reports no symptoms and 4 reports maximum symptom severity, frequency or life interference
Percentage of patients experiencing all acute grade 2 + toxicity, including haematological toxicity, attributable to radiotherapy, up to 12 weeks following radiotherapy
Percentage of patients experiencing all acute grade 2 + toxicity, including haematological toxicity, attributable to radiotherapy, up to 12 weeks following radiotherapy, as assessed by CTCAE 6.0
Percentage of patients experiencing all acute grade 3 / 4 toxicity, including haematological toxicity, attributable to radiotherapy, up to 12 weeks following radiotherapy
Percentage of patients experiencing all acute grade 3 / 4 toxicity, including haematological toxicity, attributable to radiotherapy, up to 12 weeks following radiotherapy, as assessed by CTCAE 6.0
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