OncoMatch/Clinical Trials/NCT04779554
Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC
Is NCT04779554 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Mitomycin C, flat dose 40 mg and Mitomycin C, weight-based dose 12.5 mg/m2 for peritoneal carcinomatosis.
Treatment: Mitomycin C, flat dose 40 mg · Mitomycin C, weight-based dose 12.5 mg/m2 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Disease stage
Metastatic disease required
Grade: low-grade (for appendiceal mucinous neoplasm)
low-grade appendiceal mucinous neoplasm, pseudomyxoma peritonei, appendiceal cancer with peritoneal carcinomatosis, colorectal cancer with peritoneal carcinomatosis
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Chemotherapy or radiotherapy within 4 weeks prior to entering the study
Cannot have received: radiation therapy
Chemotherapy or radiotherapy within 4 weeks prior to entering the study
Lab requirements
Blood counts
adequate organ and marrow function
Kidney function
adequate organ and marrow function
Liver function
adequate organ and marrow function
Adequate organ and marrow function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Kentucky · Lexington, Kentucky
- University of Vermont Medical Center · Burlington, Vermont
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify