- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01810757
Study of Weekly Radiotherapy for Bladder Cancer (HYBRID)
A Multicentre Randomised Phase II Study of HYpofractionated Bladder Radiotherapy With or Without Image Guided aDaptive Planning
Background Localised muscle invasive bladder cancer (MIBC) is life-threatening and can cause significant symptoms. Around 50% of patients with MIBC who are referred for radiotherapy are unfit for standard radical treatment (surgery or daily radiotherapy with chemotherapy), but would have a normal life expectancy if their cancer were adequately controlled. Retrospective studies suggest that radiotherapy which is given weekly using fewer fractions and higher doses (hypofractionated), may be an alternative where daily radiotherapy is not an option.
Radiotherapy treatment is planned based on information from a CT scan which shows the position and shape of the bladder. This plan needs to take into account the fact that the bladder's shape and position can change, depending on how full it is and because of where it is in relation to the bowel. A safety margin is therefore added around the bladder on the planned treatment, to reduce the risk of missing any of the bladder with the radiotherapy.
It is now possible to take scans of the bladder's position before each treatment and adjust the position of the treatment plan accordingly to ensure the bladder is fully covered by it. In this study we are also looking at whether it is possible to design a series of treatment plans with different size safety margins and then choose one that fits best for each particular day. This is called 'adaptive radiotherapy'. This technique may enable accurate treatment delivery using smaller safety margins and this might help to reduce side effects.
Aims
In patients with MIBC not suitable for cystectomy or daily radiotherapy we aim to assess:
- whether treatment using adaptive planning can be successfully delivered at multiple sites across the UK and results in acceptable levels of toxicity
- the local tumour control rate achieved by hypofractionated weekly radiotherapy
- the requirement to treat with adaptive planning.
How results will be used Results will provide robust evidence for use of hypofractionated radiotherapy and assess whether this is a plausible and worthwhile treatment in this patient population. The randomised element of the trial will support the implementation of image-guided adaptive radiotherapy for bladder cancer in the UK. HYBRID will provide evidence on the benefits or otherwise of this methodology and inform the development of further trials in this and other patient groups.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
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Cambridge, 영국
- Addenbrooke's Hospital
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Cardiff, 영국
- Velindre Cancer Centre
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Ipswich, 영국
- Ipswich Hospital
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Leeds, 영국
- St James's University Hospital
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London, 영국
- University College London
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London, 영국
- Royal Marsden NHSFT
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London, 영국
- Guy's & St Thomas's Hospital
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Norwich, 영국
- Norfolk & Norwich University Hospitals NHS Foundation Trust
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Preston, 영국
- Royal Preston Hospital
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Romford, 영국
- Queens Hospital
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Wirral, 영국
- Clatterbridge Cancer Centre
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Written informed consent
- Age ≥18 years
- Histologically confirmed invasive bladder carcinoma (T2-T4a N0 M0; any histological sub-type)
- Unsuitable for radical cystectomy or daily fractionated radiotherapy for any reason (including performance status, co-morbidity, patient refusal)
- Expected survival >6 months
- WHO performance status 0-3
- Willing to undergo post treatment cystoscopy
Exclusion Criteria:
- Nodal or metastatic disease
- Concurrent malignancy
- Previous pelvic radiotherapy
- Urinary catheter in-situ
- Any other contra-indication to radiotherapy (e.g. inflammatory bowel disease)
- Unable to attend for post treatment follow up
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Standard planning
Standard planning radiotherapy
|
36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
|
실험적: Adaptive planning
Adaptive planning radiotherapy
|
36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Proportion of patients experiencing severe acute non-genitourinary side effects following radiotherapy.
기간: 12 weeks from start of radiotherapy
|
Acute CTC non-genitourinary toxicity grade 3 or higher.
|
12 weeks from start of radiotherapy
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Local control
기간: 3 months
|
Presence of cancer in the bladder 3 months after treatment
|
3 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Robert Huddart, Institute of Cancer Research/RMNHSFT
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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