Comparing flat dose and weight-based chemotherapy for peritoneal carcinomatosis
A Randomized Phase 2 Trial of Flat Dose vs. Weight-based Dose of Intra-peritoneal (IP) Chemotherapy for Patients Undergoing Cytoreductive Surgery and Heated Intra-peritoneal Chemotherapy (CRS/HIPEC) for Advanced Gastrointestinal Malignancy
This study is testing whether giving a flat dose or a dose based on body weight of a chemotherapy drug can help people with certain cancers that have spread to the abdominal area do better after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 2 sites (Lexington, Kentucky and 1 other locations) |
| Trial ID | NCT04779554 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of flat dose versus weight-based dosing of Mitomycin C in patients undergoing cytoreductive surgery and heated intra-peritoneal chemotherapy (HIPEC) for peritoneal carcinomatosis. The study aims to determine which dosing method provides better outcomes in terms of overall survival and treatment efficacy. Participants will be randomly assigned to receive either a flat dose of 40 mg or a weight-based dose of 12.5 mg/m2 of Mitomycin C during their treatment. The trial focuses on patients with specific types of gastrointestinal malignancies that have spread to the peritoneal cavity.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with low-grade appendiceal mucinous neoplasm, appendiceal cancer with peritoneal carcinomatosis, or colorectal cancer with peritoneal carcinomatosis who are eligible for surgery.
Not a fit: Patients with extra-abdominal metastases, untreated lung metastases, or significant liver metastases are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for patients with peritoneal carcinomatosis, potentially extending survival rates.
How similar studies have performed: Previous studies have shown promising results with HIPEC in treating peritoneal carcinomatosis, suggesting that this approach may be effective, though the specific dosing comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lexington, Kentucky and 1 other locations
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
- University of Vermont Medical Center — Burlington, Vermont, United States (Recruiting)
Study contacts
- Principal investigator: Prakash Pandalai, MD — University of Kentucky
- Study coordinator: Prakash Pandalai, MD
- Email: Prakash.Pandalai@uky.edu
- Phone: 859-323-8920
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.