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MRI-Guided Adaptive Radiotherapy for Limited Peritoneal Metastases (MARACAS Trial).
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Summary
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.
Official title: MARACAS: A Phase II Trial of MRI-guided Adaptive Stereotactic RAdiotherapy in oligometastatiC Patients With Peritoneal Spread.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2026-07
Completion Date
2032-07
Last Updated
2026-05-18
Healthy Volunteers
No
Interventions
MRI-guided stereotactic body radiotherapy
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.
Locations (1)
Gemelli ART (Advanced Radiation Therapy)-Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy