NCT04779554 Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC
| NCT ID | NCT04779554 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Prakash Pandalai |
| Condition | Peritoneal Carcinomatosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-06-04 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2021-06-04 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Prakash Pandalai, MD
PRINCIPAL INVESTIGATOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT04779554 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peritoneal Carcinomatosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04779554 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04779554 currently recruiting?
Yes, NCT04779554 is actively recruiting participants. Contact the research team at Prakash.Pandalai@uky.edu for enrollment information.
Where is the NCT04779554 trial being conducted?
This trial is being conducted at Lexington, United States, Burlington, United States.
Who is sponsoring the NCT04779554 clinical trial?
NCT04779554 is sponsored by Prakash Pandalai. The principal investigator is Prakash Pandalai, MD at University of Kentucky. The trial plans to enroll 100 participants.