Actively Recruiting
Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC
Led by Prakash Pandalai · Updated on 2026-04-01
100
Participants Needed
2
Research Sites
347 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Peritoneal carcinomatosis from advanced gastro-intestinal malignancy has historically been associated with poor overall survival (≤ 12 months) with few treatment options. Cytoreductive surgery (CRS), which involves removal of all macroscopic tumor nodules, combined with direct administration of heated intra-peritoneal (IP) chemotherapy (HIPEC) to the affected peritoneal surfaces, has been shown to be an effective treatment option that extends overall survival among certain cases of peritoneal carcinomatosis. IP chemotherapy allows delivery of a high dose of cytostatic drug directly onto the peritoneal surfaces at risk for microscopic residual disease while systemic exposure remains limited. Additionally, hyperthermia is known to enhance the cytotoxicity of several agents (including Mitomycin C) and improves the depth of peritoneal penetration. This trial will be a randomized phase 2 comparison of flat dose versus weight-based dose Mitomycin C. The hypothesis of this study is that HIPEC weight-based dosing may result in similarly effective peritoneal Mitomycin C concentrations with less systemic absorption and potential systemic toxicity, compared with the HIPEC flat dosing approach in patients undergoing CRS/HIPEC.
CONDITIONS
Official Title
Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with low-grade appendiceal mucinous neoplasm, pseudomyxoma peritonei, appendiceal cancer with peritoneal carcinomatosis, or colorectal cancer with peritoneal carcinomatosis
- ECOG performance status less than 3
- Candidate for complete cytoreductive surgery
- Life expectancy greater than 3 months
- Adequate organ and marrow function
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Any extra-abdominal metastases
- Untreated lung metastases
- Liver metastases not suitable for removal or ablation
- Known brain metastases
- Chemotherapy or radiotherapy within 4 weeks before study entry
- Significant side effects from prior cancer treatment
- Currently receiving other investigational treatments
- History of allergic reactions to drugs similar to Mitomycin C
- Pregnant or breastfeeding women
- Uncontrolled ongoing illness
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
2
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
Research Team
P
Prakash Pandalai, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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