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NCT04779554 · ClinicalTrials.gov registry record · Phase 2
Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC
A Phase 2 study of Peritoneal Carcinomatosis, sponsored by Prakash Pandalai.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT04779554 is a Phase 2 study of Peritoneal Carcinomatosis that is actively recruiting participants, run by Prakash Pandalai. The registered enrollment target is 100 participants, above the 53-participant average among 14 other Peritoneal Carcinomatosis trials with a reported enrollment target (89% higher). The trial reports 2 study locations across 2 states.
The verdict
NCT04779554, a Phase 2 study of Peritoneal Carcinomatosis, is actively recruiting participants, sponsored by Prakash Pandalai.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 53-participant average among 14 other Peritoneal Carcinomatosis trials with a reported enrollment target (89% higher). The listed sponsor is Prakash Pandalai, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT04779554 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Kentucky, Vermont.
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.
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).
Who is sponsoring clinical trial NCT04779554?
This trial is sponsored by Prakash Pandalai, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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