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Not yet recruiting NCT07593261

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

Phase II Interventional Peritoneal Carcinomatosis Oligometastatic Disease Peritoneal Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI-guided stereotactic body radiotherapy.
Who it may be relevant to
Registry conditions: Peritoneal Carcinomatosis, Oligometastatic Disease, Peritoneal Metastases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

MARACAS: A Phase II Trial of MRI-guided Adaptive Stereotactic RAdiotherapy in oligometastatiC Patients With Peritoneal Spread.

Overview

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.

Detailed description

Peritoneal carcinomatosis (PC) represents a frequent metastatic pattern in gastrointestinal and gynecological malignancies and is associated with poor prognosis and limited therapeutic options. Although cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) may improve outcomes in selected patients, many patients are not candidates for surgery because of recurrent disease, comorbidities, or poor performance status.

MRI-guided stereotactic body radiotherapy (MRIgSBRT) allows highly conformal radiation delivery with online adaptive planning and real-time tumor tracking, potentially improving treatment precision and sparing surrounding organs at risk in anatomically complex abdominal sites.

This prospective single-center phase II study will evaluate MRIgSBRT in patients with oligometastatic peritoneal carcinomatosis with up to 5 MRI-visible lesions and PCI ≤20. Treatment will be delivered using a hybrid MRI-linear accelerator with adaptive planning according to daily anatomical variations.

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 assessed according to CTCAE v5.0.

Interventions

  • Device 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.

Primary outcome measures

  • Radiological Response Rate (RR) [Time frame: Up to 12 months after completion of MRIgSBRT]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Gemelli ART (Advanced Radiation Therapy)-Fondazione Policlinico Universitario Agostino Gem — Roma

Identifiers

NCT: NCT07593261 · 26983

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗