Daily Adjustment of the Radiation Dose in MRI-guided Stereotactic Radiotherapy for Tumors in the Abdominal and Pelvic Regions (ACTION)
Adaptive Fractionation in Online MR-guided SBRT for Abdominal and Pelvic Target Volumes
SBRT delivers high-dose radiation to precisely defined target volumes and is an effective locally ablative treatment option for both primary tumours and oligometastases in various settings, including lesions in the abdomen or pelvis. However, SBRT in these regions faces considerable challenges such as inter-fractional organ motion and anatomical deformation, which can compromise treatment precision.
MR-guided SBRT offers a solution, providing superior soft-tissue contrast and enabling real-time, online treatment plan adaptation over the course of SBRT. This approach reduces the risk of geographical miss and overdose to adjacent, vulnerable OARs. Currently, MR-guided SBRT uses a fixed dose per fraction, only adjusting target volume and OAR contours for anatomical changes when performing plan adaptation. However, overlaps between planning target volumes (PTVs) and dose-limiting OARs regularly require compromises in PTV coverage. To address this, AF aims to also adjust dose per fraction based on daily PTV-OAR overlap. With this approach, more dose is applied on treatment days with less PTV-OAR overlap while less dose is applied on days with more PTV-OAR overlap. This trial assesses the feasibility of AF in MR-guided SBRT for abdominal and pelvic tumours that show PTV-overlap with one or more dose-limiting OARs, ultimately aiming to enhance PTV dose coverage without increasing toxicity.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jan Unkelbach, Prof. Dr. rer. nat.
- 전화번호: +41 44 255 85 49
- 이메일: jan.unkelbach@usz.ch
연구 연락처 백업
- 이름: Lena Kretzschmar, Dr. med.
- 이메일: lena.kretzschmar@usz.ch
연구 장소
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Canton of Zurich
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Zurich, Canton of Zurich, 스위스, 8091
- 모병
- University Hospital Zurich
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Karnofsky performance status ≥70
- Abdominal or pelvic malignancy (primary or secondary) with previous histological confirmation of the primary tumour, amenable to SBRT in 5 fractions (excluding SBRT to primary tumour in patients with prostate cancer) Note: patients with primary prostate cancer are eligible, but SBRT to the primary tumour in the prostate cannot be performed within the study
- Total prescribed SBRT dose > 30 Gy (constraint for dose-limiting OAR) over 5 treatment fractions
- Distance of the GTV ≤ 1 cm from at least one dose-limiting OAR (bowel / duodenum / stomach) in the available diagnostic images
- Patients able to tolerate long (approximately 60 minutes) treatment time according to clinical evaluation of the treating radiation oncologist
- Patients willing and able to comply with scheduled visits, treatment, and other trial procedures
Exclusion Criteria:
- Previous radiation therapy directly overlapping with planned SBRT (type I re-irradiation)
- More than one PTV irradiated in the same plan
- Contraindications for MRI, e.g., patients with metal fragments or implanted devices that are not MR compatible such as certain types of pacemakers and aneurysm clips or severe claustrophobia
- SBRT not indicated or not possible
- Inability to follow the procedures of the trial, e.g. due to language problems of the participant
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: RT with AF
Patients with PTV/OAR overlap will receive AF, with dose adapted daily based on anatomy.
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The fraction dose to the PTV will be adapted based on the volume overlap of PTV and the dose-limiting OAR(s) (bowel / duodenum / stomach) on the planning MRI scan of the day ("geometry-of-the-day").
The treatment plan is then approved by the treating physician and independently verified according to department-internal standard.
MR-guided fraction dose adaptation will be repeated at each of the 5 fractions, until the prescribed total dose is reached.
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활성 비교기: RT without AF
Patients without PTV/OAR overlap will receive standard fractionated treatment.
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Patients that qualify for inclusion in the study but for whom AF is no viable treatment due to lacking PTV/OAR overlap in the planning scans.
These patients are treated according to clinical standard of care (SoC), i.e. without dose adaptation, and function as a control group.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Proportion of patients with successful daily dose adaptation
기간: from enrollment to end of treatment at 1-2 weeks
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Proportion of patients treated with daily dose-adapted treatment, who received at least one fraction of non-uniformly fractionated treatment with expectation of a benefit in PTV-coverage of ≥ 1ccGy
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from enrollment to end of treatment at 1-2 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Acute treatment toxicities
기간: during treatment (1-2 weeks) and until 90 days after
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Acute treatment toxicities for all included patients measured with Common Terminology Criteria for Adverse Events
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during treatment (1-2 weeks) and until 90 days after
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Interfractional variation in PTV/OAR overlap volume
기간: during treatment (1-2 weeks)
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interfractional variation in PTV/OAR overlap volume, in cc
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during treatment (1-2 weeks)
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Interfractional variation in GTV/OAR distance
기간: during treatment (1-2 weeks)
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interfractional variation in GTV/OAR distance, in mm
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during treatment (1-2 weeks)
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Dosimetric difference in PTV-coverage between algorithm-based calculation and the reference plan
기간: after end of treatment (2 weeks after last fraction)
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PTV coverage quantified as the area above the dose-volume-histogram curve measured in cc x Gy
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after end of treatment (2 weeks after last fraction)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Reinhardt Krcek, Dr. med., University of Zurich
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RAO-25-019
- 2026-00067 (기타 식별자: BASEC)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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