Chemotherapy After Surgery for Malignant Peritoneal Mesothelioma
This study is looking at whether giving chemotherapy directly into the abdomen (intraperitoneal) or through a vein (intravenous) after surgery and HIPEC (heated chemotherapy) is a better treatment for people with malignant peritoneal mesothelioma. You might receive Pemetrexed and Cisplatin, or Carboplatin might be used instead of Cisplatin. To join, you must be at least 18 years old, have a confirmed diagnosis of epithelioid malignant peritoneal mesothelioma, and have had most or all of your cancer removed by surgery. The study will measure how long you live without the cancer growing (Progression Free Survival) for up to 24 months. The current status of this study is unclear, and it plans to enroll 64 people.
- Study design
- This is an interventional study comparing two ways of giving chemotherapy after surgery. It plans to enroll 64 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will follow participants for up to 24 months to measure how long they live without the cancer growing.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06057935
A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma
Recruiting
PHASE2Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~64 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:PemetrexedCisplatinCarboplatin
At a glance
Recruiting sites
9 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival
Measured over up to 24 months
Conditions
Where it's being run
13 sites across 7 statesNew Jersey4
New York4
Illinois1
Michigan1
Missouri1
Nebraska1
Pennsylvania1
Study leadership
- Garrett Nash, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patient age 18 years or older, both sexes.
Clinical diagnosis of MPM at enrolling institution.
Prior to randomization, intraoperative pathologic confirmation of epithelioid MPM at enrolling institution.
Complete or near-complete CRS achieved.
Patient must be planning to undergo complete cytoreduction of all peritoneal disease.
ECOG performance status ≤ 1.
Hematology: ANC ≥ 1,500/µl.
Platelets \> 75,000/µl.
Adequate renal function: creatinine \< 1.5× the upper limit of normal (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).
Women of childbearing potential with a negative pregnancy test result (urine or blood) who agree to use an effective contraceptive method. Reliable contraception should be used from trial screening and must be continued throughout the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
A man participating in this study must agree to utilize a reliable barrier form of contraception for the duration of the study
Signed and dated written informed consent to participate in this clinical trial must be obtained prior to any study procedure.
Exclusion
Subjects who have previously undergone intraperitoneal chemotherapy or systemic chemotherapy for peritoneal mesothelioma.
Subjects who have previously received platinum-containing chemotherapy regimens.
Subjects with preoperative or intraoperative biopsy consistent with sarcomatoid mesothelioma, well-differentiated papillary mesothelioma, or benign multicystic mesothelioma.
Other prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, adequately treated malignancies for which there has been no evidence of activity for more than three years, or indolent tumors for which observation over two years is a reasonable option.
High suspicion for extra-abdominal metastases.
Women who are pregnant or lactating.
Active coronary artery disease (defined as unstable angina or a positive cardiac stress test). Subjects with a history of coronary artery disease may be included if they have had a normal stress test within 60 days of enrollment or are determined by a cardiologist to be of acceptable perioperative risk.
Uncontrolled hypertension defined as \>140/90 and not cleared for surgery at the time of consent.
New York Heart Association (NYHA) Class II or higher congestive heart failure; restrictive or obstructive pulmonary disease that would limit study compliance or place the patient at unacceptable risk for participation in the study.
History of cerebrovascular disease that would limit study compliance or place the patient at unacceptable risk for participation in the study.
Subjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or place them at an unacceptable risk for participation in the study.
Patients with known cisplatin, carboplatin, pemetrexed or mitomycin allergy.
Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.
Any condition that would preclude the ability to deliver appropriate IP therapy.
Use of an oral medication, lacking a suitable non-oral substitute, that if held for up to ten days, would be felt an unacceptable risk by the investigator.
Life expectancy \< 12 weeks.
What this trial measures
- Progression Free Survivalup to 24 months
Progression Free Survival in the two treatment arms.