Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC

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 pe

Trial Details

NCT ID
NCT04779554
Phase
PHASE2
Sponsor
Prakash Pandalai
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • Mitomycin C, flat dose 40 mg
  • Mitomycin C, weight-based dose 12.5 mg/m2
Locations (sample)
  • Lexington, Kentucky, United States|37.98869,-84.47772
  • Burlington, Vermont, United States|44.47588,-73.21207

Key Eligibility Criteria

  • Patients diagnosed with one of the following: low-grade appendiceal mucinous neoplasm, pseudomyxoma peritonei, appendiceal cancer with peritoneal c…
  • ECOG performance status \< 3
  • Candidate for grossly complete cytoreductive surgery
  • Life expectancy greater than 3 months

For full eligibility, visit ClinicalTrials.gov.

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