MRI-Guided Adaptive Radiotherapy for Limited Peritoneal Metastases (MARACAS Trial). (MARACAS)
MARACAS: A Phase II Trial of MRI-guided Adaptive Stereotactic RAdiotherapy in oligometastatiC Patients With Peritoneal Spread.
This prospective phase II study evaluates the efficacy and safety of MRI-guided stereotactic body radiotherapy (MRIgSBRT) in patients with oligometastatic peritoneal carcinomatosis from gastrointestinal or gynecological tumors. Eligible patients with up to 5 MRI-visible peritoneal lesions and PCI ≤20 will be treated with MRIgSBRT using a hybrid MRI-linear accelerator with online adaptive planning and real-time tumor tracking.
The primary endpoint is radiologic response rate according to RECIST 1.1 criteria. Secondary endpoints include overall survival, progression-free survival, local control, chemotherapy-free survival, and treatment-related toxicity. The study aims to assess MRIgSBRT as a safe and non-invasive treatment option for selected patients with limited peritoneal metastatic disease.
연구 개요
상세 설명
Peritoneal carcinomatosis (PC) represents a frequent metastatic pattern in gastrointestinal and gynecological malignancies and is associated with poor prognosis and limited therapeutic options. Although cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) may improve outcomes in selected patients, many patients are not candidates for surgery because of recurrent disease, comorbidities, or poor performance status.
MRI-guided stereotactic body radiotherapy (MRIgSBRT) allows highly conformal radiation delivery with online adaptive planning and real-time tumor tracking, potentially improving treatment precision and sparing surrounding organs at risk in anatomically complex abdominal sites.
This prospective single-center phase II study will evaluate MRIgSBRT in patients with oligometastatic peritoneal carcinomatosis with up to 5 MRI-visible lesions and PCI ≤20. Treatment will be delivered using a hybrid MRI-linear accelerator with adaptive planning according to daily anatomical variations.
The primary endpoint is radiologic response rate according to RECIST 1.1 criteria. Secondary endpoints include overall survival, progression-free survival, local control, chemotherapy-free survival, and treatment-related toxicity assessed according to CTCAE v5.0.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Luca Boldrini
- 전화번호: +390630158195
- 이메일: luca.boldrini@policlinicogemelli.it
연구 장소
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Roma, 이탈리아, 000168
- Gemelli ART (Advanced Radiation Therapy)-Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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연락하다:
- Luca Boldrini
- 전화번호: +390630155701
- 이메일: luca.boldrini@policlinicogemelli.it
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수석 연구원:
- Luca Boldrini
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age ≥18 years
- ECOG performance status 0-2
- Life expectancy ≥6 months
- Up to 5 MRI-visible peritoneal nodules
- PCI ≤20
- No prior radiotherapy in the same abdominal region within 6 months
- Signed informed consent
- History of prior CRS and/or HIPEC
Exclusion Criteria:
- Diffuse peritoneal carcinomatosis
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (those conditions should be discussed with the patient before registration in the trial)
- Significant comorbidities (such as: severe cardiac or coagulative disease, moderate or severe
- restrictive/obsiructive lung deficit, severe cognitive impairment, moderate and severe renal and hepatic impairment.
- Pregnancy or breastfeeding
- MRI contraindications (e.g., pacemaker, severe claustrophobia)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: MRI-guided SBRT
Patients with oligometastatic peritoneal carcinomatosis will receive MRI-guided stereotactic body radiotherapy (MRIgSBRT) delivered with a hybrid MRI-linear accelerator using online adaptive planning and real-time tumor tracking.
Treatment dose will range from 30 to 50 Gy in 5 fractions according to clinical judgment and organ-at-risk constraints.
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Patients will receive MRI-guided stereotactic body radiotherapy (MRIgSBRT) delivered using a hybrid MRI-linear accelerator with online adaptive planning and real-time tumor tracking.
Treatment will consist of 30-50 Gy delivered in 5 fractions according to clinical judgment, target characteristics, and organ-at-risk constraints.
Daily adaptive replanning may be performed to account for anatomical changes and optimize dose delivery in patients with oligometastatic peritoneal carcinomatosis.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Radiological Response Rate (RR)
기간: Up to 12 months after completion of MRIgSBRT
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RR: The response rate will be calculated as the proportion of patients achieving a complete or partial radiological response out of the total number of evaluable patients according to RECIST 1.1 criteria
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Up to 12 months after completion of MRIgSBRT
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공동 작업자 및 조사자
수사관
- 수석 연구원: Luca Boldrini, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
기타 연구 ID 번호
- 26983
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