NCT04779554 · Prakash Pandalai
Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC
What this study is about
Peritoneal carcinomatosis from advanced gastro-intestinal malignancy has historically been associated with poor how long patients live (≤ 12 months) with few treatment options.
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Peritoneal carcinomatosis from advanced gastro-intestinal malignancy has historically been associated with poor overall survival (≤ 12 months) with few treatment options.
Interventions
DRUG
Mitomycin C, flat dose 40 mg
Mitomycin C will be delivered as heated intraperitoneal chemotherapy (HIPEC) in two flat doses. Dose 1 will be 30mg at minute 0 and dose 2 will be 10 mg at minute 45.
DRUG
Mitomycin C, weight-based dose 12.5 mg/m2
Mitomycin C will be delivered as heated intraperitoneal chemotherapy (HIPEC) in two weight-based doses of 9.5 mg/m2 at minute 0 and 3 mg/m2 at minute 45.
Primary outcome measures
Area Under the Curve (AUC) - Pharmacokinetics
Time frame: Approximately 20 hours
Drug exposure will be measured by calculating the area under the curve (AUC) or integral of a plasma concentration-time curve. Samples will be collected at 0,15, 30, 60 and 90 minutes intra-operatively, and 2, 4, and 12 hours postoperatively.
Drug Clearance (CL) - Pharmacokinetics
Time frame: Approximately 20 hours
Drug clearance will be calculated as the volume of plasma cleared per unit time. Samples will be collected at 0,15, 30, 60 and 90 minutes intra-operatively, and 2, 4, and 12 hours postoperatively.
Drug Half-Life (T1/2) - Pharmacokinetics
Time frame: Approximately 20 hours
Drug half-life will be calculated as the time required for the plasma Mitomycin C concentration to be half of its maximum concentration. Samples will be collected at 0,15, 30, 60 and 90 minutes intra-operatively, and 2, 4, and 12 hours postoperatively.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients diagnosed with one of the following: low-grade appendiceal mucinous neoplasm, 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 w
Where
- Lexington, Kentucky
- Burlington, Vermont
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 1, 2026 · Source of record for eligibility and locations