This phase II trial studies how well cytoreductive surgery and hyperthermic intraperitoneal mitomycin C followed by standard chemotherapy works in treating patients with peritoneal carcinomatosis. Cytoreductive surgery helps to reduce the number of cancer cells prior to treatment. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Drugs used in chemotherapy, such as mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Infusing mitomycin C directly into the abdomen may kill more tumor cells while reducing side effects. Giving cytoreductive surgery with hyperthermic intraperitoneal mitomycin C may kill more tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02040142.
PRIMARY OBJECTIVES:
I. This prospective trial will evaluate the technical parameters including completeness of cytoreduction, achievement of hyperthermia, morbidity and mortality in patients with peritoneal carcinomatosis of colorectal, gastric, appendiceal, pseudomyxoma peritonei and peritoneal mesothelioma origin undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with mitomycin C.
SECONDARY OBJECTIVES:
I. To evaluate time to progression and progression free survival (PFS) for patients with peritoneal carcinomatosis treated with cytoreductive surgery (CRS) + hyperthermic intraperitoneal chemotherapy (HIPEC).
II. To evaluate overall survival for patients with peritoneal carcinomatosis treated with CRS + HIPEC.
III. To assess quality of life (QOL) score for patients undergoing CRS + HIPEC.
IV. To evaluate epigenetic and genomic changes following treatment with HIPEC and association of these changes with improved progression free survival.
OUTLINE:
Patients undergo cytoreduction surgery and hyperthermic mitomycin C intraperitoneally (IP) over 90 minutes. After surgery and hyperthermia treatment, patients receive standard systemic chemotherapy.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 4 years.
Lead OrganizationMontefiore Medical Center-Weiler Hospital
Principal InvestigatorHaejin In