Trials / Recruiting
RecruitingNCT06057935
A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
- Malignant Peritoneal Mesothelioma
- Peritoneal Mesothelioma
- Mesothelioma
- Mesothelioma, Malignant
- Malignant Mesothelioma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pemetrexed | Pemetrexed will be administered intravenously |
| DRUG | Cisplatin | Cisplatin will be administered intravenously |
| DRUG | Carboplatin | Possible substitution with carboplatin based on clinician discretion |
Timeline
- Start date
- 2023-09-21
- Primary completion
- 2028-09-21
- Completion
- 2028-09-21
- First posted
- 2023-09-28
- Last updated
- 2025-07-22
Locations
13 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06057935. Inclusion in this directory is not an endorsement.