Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC

Launched by PRAKASH PANDALAI · Feb 27, 2021

Keywords

ClinConnect Summary

This clinical trial is comparing two different ways of giving a chemotherapy drug called Mitomycin C to patients with a condition known as peritoneal carcinomatosis, which often arises from advanced gastrointestinal cancers. The trial aims to find out whether giving a flat dose of this drug is just as effective as giving a dose based on a patient's weight, with the hope that weight-based dosing may reduce side effects. Participants will undergo a surgical procedure to remove visible tumors, followed by heated chemotherapy delivered directly into the abdominal cavity.

To be eligible for this study, patients should have specific types of cancer that have spread to the abdominal lining, be physically able to undergo surgery, and have a life expectancy of more than three months. Participants can expect to receive close monitoring throughout the trial to ensure their safety and to evaluate how well the treatment is working. This trial is currently recruiting participants of all genders, aged between 65 and 74, and aims to provide new insights into improving treatment outcomes for those facing this challenging condition.

Gender

ALL

Eligibility criteria

• 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 women
• • Uncontrolled ongoing illness