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

RecruitingPhase 2Ages 18 Years - anyAllPrakash Pandalai
NCT04779554 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 com

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients diagnosed with one of the following: low-grade appendiceal mucinous neoplasm, pseudomyxoma peritonei, appendiceal cancer with peritoneal carcinomatosis, colorectal cancer with peritoneal carcinomatosis * ECOG performance status \< 3 * Candidate for grossly complete cytoreductive surgery * Life expectancy greater than 3 months * Adequate organ and marrow function * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Any extra-abdominal metastases * Untreated lung metastases * Liver metastases not amenable to resection or ablation * Known brain metastases * Chemotherapy or radiotherapy within 4 weeks prior to entering the study * Presence of residual significant adverse events attributed to prior cancer treatment * Currently receiving any other investigational therapeutic agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Mitomycin C. * Pregnant or breast-feeding women * Uncontrolled ongoing illness
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What it tests

  • Mitomycin C, flat dose 40 mg
  • Mitomycin C, weight-based dose 12.5 mg/m2
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Where

2 sites
University of Kentucky
Lexington, United States
University of Vermont Medical Center
Burlington, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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