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Clinical Trial Summary

This phase II trial studies the effects of hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with pancreatic cancer that has spread to the internal abdominal area (peritoneal metastasis). Chemotherapy drugs, such as mitomycin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. HIPEC involves "heated" chemotherapy that is placed directly in the abdomen through laparoscopic instruments, instead of through an intravenous injection. This study may help doctors determine how safe and effective HIPEC work in treating patient with pancreatic cancer.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To assess short-term morbidity and disease-free survival outcomes for patients with pancreatic adenocarcinoma with limited low volume peritoneal metastasis or positive peritoneal cytology undergoing hyperthermic intraperitoneal chemotherapy. SECONDARY OBJECTIVE: I. To evaluate the efficacy of a polymerase chain reaction (PCR)-based quantitative cell-free deoxyribonucleic acid (DNA) KRAS mutation assay in identifying patients at risk of peritoneal recurrence/progression. OUTLINE: Patients undergo HIPEC with mitomycin and cisplatin over 60 minutes in the absence of disease progression or unacceptable toxicity. Patients may undergo additional HIPEC with mitomycin and cisplatin up to 5 times. After completion of study treatment, patients are followed up every 6 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04858009
Study type Interventional
Source Mayo Clinic
Contact
Status Not yet recruiting
Phase Phase 2
Start date May 15, 2021
Completion date May 31, 2026

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