Short-course Hypofractionated Online-adaptive Radiotherapy for the Treatment of ENdometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of patients experiencing acute grade 3 or 4 gastrointestinal or genitourinary toxicity, attributable to radiotherapy
研究概览
简要总结
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.
详细描述
Background and Rationale Endometrial cancer treatment often requires a multi-modality approach, with patients usually treated with up-front surgical resection followed by a combination of adjuvant chemotherapy, adjuvant external beam radiotherapy (EBRT), and vaginal vault brachytherapy. During EBRT, the target treatment area includes the mobile vaginal vault, necessitating large clinical target volume (CTV) to planning target volume (PTV) margins (10 to 15 mm) of the vaginal vault to account for daily interfraction motion. These large margins lead to significant radiation dosage to the adjacent bladder, rectum, and bowel, which increases the risk of toxicity.
While hypofractionation offers resource and health-economic advantages, its use in endometrial cancer has historically been limited due to the large fields required and the associated risks of late adverse normal tissue effects. However, Online-Adaptive Radiotherapy (OART) allows for the daily re-definition of targets and surrounding organs, and daily replanning, whilst the patient remains on the treatment couch. By mitigating interfraction motion, CT-based OART (CT-OART) can safely reduce the CTV to PTV margins, making the delivery of a hypofractionated dose feasible. This trial leverages CT-OART to test the safety and feasibility of a shortened, ultra-hypofractionated treatment course for post-operative radiotherapy in endometrial cancer.
Study Aims The primary aim is to determine the safety of a shortened ultra-hypofractionation regimen of 30 Gray in 5 fractions, delivered via a CT-OART approach for the post-operative treatment of endometrial cancer.
Secondary aims include determining the feasibility of this ultrahypofractionated regimen on a CT-online adaptive platform, assessing clinician and patient-reported acute toxicity up to 12 weeks following completion of radiotherapy, and late toxicity up to 2 years following completion of radiotherapy, assessing patient-reported quality-of-life up to 2 years following completion of radiotherapy, and assessing overall survival (OS), disease-free survival (DFS) and pelvic relapse-free survival (PRFS) up to 2 years following completion of radiotherapy.
Study Design The SHORTEN trial is a single-site, single-arm, non-blinded Phase IIA trial (R-IDEAL framework). The study aims to recruit 30 adult participants with fully resected endometrial cancer and an indication for post-operative external beam radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •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
- •WHO Performance Status 0 - 2
- •Informed written consent
排除标准
- •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
- •Hip prostheses or other metal work within the imaging field which would produce significant imaging artifact
- •Indication for adjuvant concurrent chemo-radiotherapy
结局指标
主要结局
Percentage of patients experiencing acute grade 3 or 4 gastrointestinal or genitourinary toxicity, attributable to radiotherapy
时间窗: From beginning radiotherapy, up to 12 weeks following completion of 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)
次要结局
- Feasibility of a CT Online Adaptive workflow(From Day 1 of radiotherapy treatment course, assessed at every treatment fraction for all 5 treatment fractions, up to and inclusive of final 5th radiotherapy fraction (an average duration of 10 days))
- Patient-reported acute GI and GU toxicity incidence, severity, and longitudinal change from baseline up to 12 weeks following radiotherapy(From beginning radiotherapy, up to 12 weeks following completion of radiotherapy)
- Percentage of patients experiencing all acute grade 2 + toxicity, including haematological toxicity, attributable to radiotherapy, up to 12 weeks following radiotherapy(From beginning radiotherapy, up to 12 weeks following completion of radiotherapy)
- Percentage of patients experiencing all acute grade 3 / 4 toxicity, including haematological toxicity, attributable to radiotherapy, up to 12 weeks following radiotherapy(From beginning radiotherapy, up to 12 weeks following completion of radiotherapy)
- Percentage of patients experiencing all late grade 2 + toxicity, attributable to radiotherapy, up to 2 years following radiotherapy(From beginning radiotherapy, up to 2 years following completion of radiotherapy)
- Patient-reported late GI and GU toxicity incidence, severity, and longitudinal change from baseline up to 2 years following radiotherapy(From beginning radiotherapy, up to 2 years following completion of radiotherapy)
- Change in patient-reported quality-of-life scoring from baseline up to 2 years following radiotherapy - EORTC QLQ-C30(From beginning radiotherapy, up to 2 years following completion of radiotherapy)
- Change in patient-reported quality-of-life scoring from baseline up to 2 years following radiotherapy - EORTC QLQ-EN24(From beginning radiotherapy, up to 2 years following completion of radiotherapy)
- Change in patient-reported quality-of-life scoring from baseline up to 2 years following radiotherapy - EQ-5D-5L(From beginning radiotherapy, up to 2 years following completion of radiotherapy)
- Overall survival(Up to 2 years from start of radiotherapy)
- Disease-free survival(Up to 2 years from start of radiotherapy)
- Pelvic relapse-free survival(Up to 2 years from start of radiotherapy)