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Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC
NCT04779554 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DRUG Mitomycin C, flat dose 40 mg
- DRUG Mitomycin C, weight-based dose 12.5 mg/m2
Study Locations (2)
Kentucky
- University of Kentucky — Lexington
Vermont
- University of Vermont Medical Center — Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-06-04 |
| Est. Completion | 2026-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04779554
The ClinicalTrials.gov registry entry for NCT04779554 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prakash Pandalai, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Peritoneal Carcinomatosis appearing as the primary indexed condition, and to 2 interventions — of which Mitomycin C, flat dose 40 mg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04779554 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Kentucky, Vermont. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04779554 about?
NCT04779554 is a clinical study titled "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 heat...
What is the current status of trial NCT04779554?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2021-06-04. Estimated completion is 2026-02.
What conditions does trial NCT04779554 study?
This clinical trial studies the following conditions: Peritoneal Carcinomatosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04779554?
The interventions under investigation include: Mitomycin C, flat dose 40 mg (DRUG), Mitomycin C, weight-based dose 12.5 mg/m2 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04779554?
This trial is sponsored by Prakash Pandalai, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04779554 being conducted?
This trial has 2 study locations across Kentucky, Vermont. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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