NCT06057935 · Memorial Sloan Kettering Cancer Center
A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma
What this study is about
The purpose of this study is to find out whether intraperitoneal or given through a vein (IV) chemotherapy given after cytoreductive surgery and HIPEC are effective treatments for people with malignant peritoneal mesothelioma. Outcomes will be compared by observing intraperitoneal versus given through a vein (IV) treatments to analyze if one is better than the other.
View original scientific description
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.
Interventions
DRUG
Pemetrexed
Pemetrexed will be administered intravenously
DRUG
Cisplatin
Cisplatin will be administered intravenously
DRUG
Carboplatin
Possible substitution with carboplatin based on clinician discretion
Primary outcome measures
Progression Free Survival
Time frame: up to 24 months
Progression Free Survival in the two treatment arms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 de
Where
- Chicago, Illinois
- Ann Arbor, Michigan
- St Louis, Missouri
- Omaha, Nebraska
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- New Brunswick, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
And 1 more location — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 22, 2025 · Source of record for eligibility and locations