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Clinical Trials in Italy / NCT07593261
Starting soon Phase 2

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

NCT07593261 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Phase 2
Started
2026-07
Last updated
2026-05-18

Condition(s) studied

Peritoneal CarcinomatosisOligometastatic DiseasePeritoneal Metastases

Investigational drug(s) / intervention(s)

MRI-guided stereotactic body radiotherapy

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Gemelli ART (Advanced Radiation Therapy)-Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Italy

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Other trials for the same condition

Impact of an Omega-3 Enriched Oral Nutritional Supplement on Improving Surgical Outcomes in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery Starting soon
Prospective Observational Basket Study of Stereotactic Body Radiation Therapy for OligoMetastatic Patients From Rare Tumors Recruiting
Ablative Radiosurgery vs Stereotactic RT in 5 Fractions With SIB for Oligometastatic Bone Lesions Recruiting
A Study of Radspherin® in Patients With Primary Advanced Epithelial Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery Recruiting
Enhanced Recovery After Surgery (ERAS) in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07593261 on ClinicalTrials.gov ↗ ← All trials in Italy