Clinical trial · Interventional
MRI-Guided Adaptive Radiotherapy for Limited Peritoneal Metastases (MARACAS Trial).
MARACAS: A Phase II Trial of MRI-guided Adaptive Stereotactic RAdiotherapy in oligometastatiC Patients With Peritoneal Spread.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oligometastatic Disease | — | UNRESOLVED | — |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
| Peritoneal Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI-guided stereotactic body radiotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI-guided SBRT
- description
- 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.
- interventionNames
- Device: MRI-guided stereotactic body radiotherapy
Primary outcomes (1)
- measure
- Radiological Response Rate (RR)
- timeFrame
- Up to 12 months after completion of MRIgSBRT
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
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