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.
Age ≥18 years
ECOG performance status 0-2
Life expectancy ≥6 months
Up to 5 MRI-visible peritoneal nodules
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.
Single group
MRI-guided stereotactic body radiotherapy
DevicePatients 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.
Radiological Response Rate (RR)
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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