Status:
RECRUITING
Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC
Lead Sponsor:
Prakash Pandalai
Conditions:
Peritoneal Carcinomatosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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), ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04779554
Start Date
June 4 2021
End Date
February 1 2026
Last Update
December 24 2025
Active Locations (2)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536
2
University of Vermont Medical Center
Burlington, Vermont, United States, 05401