Clinical Trial

MRI-Guided Adaptive Radiotherapy for Limited Peritoneal Metastases (MARACAS Trial).

Study acronym: MARACAS
Not Yet Recruiting Phase 2
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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.
Trial Details
NCT Number NCT07593261
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions Peritoneal Carcinomatosis, Oligometastatic Disease, Peritoneal Metastases
Enrollment 34 participants
Start Date 2026-07
Primary Completion 2029-07 (estimated)
Study Completion 2032-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-18