Study Comparing Fixed Dose and Weight-Based Chemotherapy for Peritoneal Cancer Treatment
Sponsor: Prakash Pandalai
ClinicalTrials ID:NCT04779554
This clinical trial is exploring two different methods of delivering chemotherapy during surgery for patients with peritoneal cancer, to see which method is more effective and has fewer side effects.
Patient Parameters
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Program Overview
Peritoneal cancer, which affects the lining of the abdomen, often has a poor outlook with limited treatment options. A combination of surgery to remove visible tumors and heated chemotherapy applied directly inside the abdomen (HIPEC) has shown promise in extending survival for some patients. This study is comparing two ways of dosing the chemotherapy drug Mitomycin C during HIPEC: a fixed dose for everyone versus a dose based on the patient's weight. The goal is to find out if the weight-based dosing is just as effective but with fewer side effects than the fixed dosing method.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with specific types of cancer affecting the abdomen, such as low-grade appendiceal mucinous neoplasm or colorectal cancer with peritoneal spread.
- Able to perform daily activities with some limitations (ECOG performance status less than 3).
- Suitable for surgery to remove visible tumors.
- Expected to live more than 3 months.
- Have good organ and bone marrow function.
- Able to understand and willing to sign a consent form to participate in the study.
Exclusion Criteria
- Cancer that has spread outside the abdomen.
- Untreated cancer in the lungs.
- Liver cancer that cannot be surgically removed or treated.
- Known cancer in the brain.
- Recent chemotherapy or radiation treatment within the last 4 weeks.
- Ongoing side effects from previous cancer treatments.
- Currently taking other experimental treatments.
- Allergic reactions to similar drugs as Mitomycin C.
- Pregnant or breastfeeding women.
- Uncontrolled ongoing health issues.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Kentucky | 40536 | Lexington | Kentucky |
| University of Vermont Medical Center | 05401 | Burlington | Vermont |
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