Actively Recruiting
A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-07-22
64
Participants Needed
13
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age 18 years or older, any gender.
- Clinical diagnosis of malignant peritoneal mesothelioma at enrolling institution.
- Intraoperative pathologic confirmation of epithelioid malignant peritoneal mesothelioma before randomization.
- Complete or near-complete cytoreductive surgery achieved or planned.
- ECOG performance status of 0 or 1.
- Absolute neutrophil count at least 1,500/µl.
- Platelet count greater than 75,000/µl.
- Adequate kidney function with creatinine less than 1.5 times upper limit of normal or creatinine clearance of 50 ml/min or more.
- Adequate liver function with bilirubin less than 1.5 mg/dl (or less than 3.0 mg/dl for patients with Gilbert's syndrome).
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception throughout the study.
- Men must agree to use reliable barrier contraception during the study.
- Signed informed consent obtained before any study procedures.
You will not qualify if you...
- Previous intraperitoneal or systemic chemotherapy for peritoneal mesothelioma.
- Prior treatment with platinum-containing chemotherapy regimens.
- Biopsy showing sarcomatoid mesothelioma, well-differentiated papillary mesothelioma, or benign multicystic mesothelioma.
- Other past cancers except cured non-melanoma skin cancer, treated in situ cervical cancer, or cancers inactive for more than three years.
- Suspicion of metastases outside the abdomen.
- Pregnant or breastfeeding women.
- Active unstable coronary artery disease or positive cardiac stress test unless cleared by cardiologist.
- Uncontrolled hypertension above 140/90 not cleared for surgery.
- Heart failure NYHA Class II or higher.
- Restrictive or obstructive lung disease limiting study participation.
- History of stroke limiting study participation.
- Other severe medical problems that limit compliance or increase risk.
- Known allergies to cisplatin, carboplatin, pemetrexed, or mitomycin.
- Extensive abdominal adhesions preventing intraperitoneal therapy.
- Conditions preventing delivery of intraperitoneal therapy.
- Use of oral medications that cannot be safely stopped for up to ten days.
- Life expectancy less than 12 weeks.
AI-Screening
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Trial Site Locations
Total: 13 locations
1
University of Chicago (Data Collection Only)
Chicago, Illinois, United States, 60637
Actively Recruiting
2
University of Michigan (Data Collection Only)
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
3
Washington University (Data Collection Only)
St Louis, Missouri, United States, 63110
Not Yet Recruiting
4
University of Nebraska (Data collection only)
Omaha, Nebraska, United States, 68198-7680
Not Yet Recruiting
5
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
6
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
7
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
8
Rutgers University (Data Collection Only)
New Brunswick, New Jersey, United States, 08903
Not Yet Recruiting
9
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
10
Memorial Sloan Kettering Westchester (Limited Protocol Activites)
Harrison, New York, United States, 10604
Actively Recruiting
11
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
12
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
13
Allegheny Health Network (Data Collection Only)
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
Research Team
G
Garrett Nash, MD
CONTACT
M
Michael Offin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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