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OncoMatch/Clinical Trials/NCT06057935

A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma

Official title: ICARuS II (Intraperitoneal Chemotherapy After cytoReductive Surgery): A Multicenter, Randomized Phase II Trial of Normothermic Intraperitoneal Chemotherapy and Intravenous Chemotherapy After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Malignant Peritoneal Mesothelioma

Is NCT06057935 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Pemetrexed and Cisplatin for malignant peritoneal mesothelioma.

Phase 2RecruitingMemorial Sloan Kettering Cancer CenterNCT06057935Data as of Oct 2026

Treatment: Pemetrexed · Cisplatin · Carboplatin — The purpose of this study is to find out whether intraperitoneal or intravenous chemotherapy given after cytoreductive surgery and HIPEC are effective treatments for people with malignant peritoneal mesothelioma. Outcomes will be compared by observing intraperitoneal versus intravenous treatments to analyze if one is better than the other.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

PemetrexedCisplatinCarboplatin

Cancer type

Mesothelioma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: intraperitoneal chemotherapy

Subjects who have previously undergone intraperitoneal chemotherapy

Cannot have received: systemic chemotherapy for peritoneal mesothelioma

Subjects who have previously undergone ... systemic chemotherapy/immunotherapy for peritoneal mesothelioma

Cannot have received: immunotherapy for peritoneal mesothelioma

Subjects who have previously undergone ... systemic chemotherapy/immunotherapy for peritoneal mesothelioma

Cannot have received: platinum-based chemotherapy

Subjects who have previously received platinum-containing chemotherapy regimens

Lab requirements

Blood counts

ANC ≥ 1,500/µl; Platelets > 75,000/µl

Kidney function

creatinine < 1.5× ULN or calculated creatinine clearance of ≥50 ml/min

Liver function

bilirubin < 1.5 mg/dl (except in patients with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL)

Hematology: ANC ≥ 1,500/µl. Platelets > 75,000/µl. Adequate renal function: creatinine < 1.5× ULN or calculated creatinine clearance of ≥50 ml/min. Adequate hepatic function: bilirubin < 1.5 mg/dl (except in patients with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Chicago (Data Collection Only) · Chicago, Illinois
  • University of Michigan (Data Collection Only) · Ann Arbor, Michigan
  • Washington University (Data Collection Only) · St Louis, Missouri
  • University of Nebraska (Data collection only) · Omaha, Nebraska
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06057935 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior intraperitoneal chemotherapy, systemic chemotherapy for peritoneal mesothelioma, immunotherapy for peritoneal mesothelioma disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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Related pages

Mesothelioma trials