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Individualized Response Assessment to Heated Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Peritoneal Carcinomatosis From Ovarian, Colorectal, Appendiceal, or Peritoneal Mesothelioma Histologies
Address: 10 Center Dr, Bethesda, MD 20892, USA
Phone: 877-451-7009
Mesothelioma Type:
- Pleural: False
- Peritoneal: False
- Pericardial: False
- Tunica Vaginalis: False
Type: N/A
Condition: Peritoneal Carcinomatosis, Peritoneal Mesothelioma, Ovarian Cancer, Gastrointestinal Cancer, Appendiceal Cancer
Description: "Background: Cytoreductive surgery (CRS) removes tumors in the abdomen. HIPEC is heated chemotherapy that washes the abdomen. CRS and HIPEC may help people with peritoneal carcinomatosis. These are tumors that have spread to the lining of the abdomen from other cancers. Researchers think they can improve results of CRS and HIPEC by choosing the chemotherapy drugs used in HIPEC. Objective: To see if HIPEC after CRS can be improved, by testing different chemotherapy drugs, using a model called the SMART (Sample Microenvironment of Resected Metastatic Tumor) System. Eligibility: Adults ages 18 and older who have peritoneal carcinomatosis that cannot be fully removed safely with surgery. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Computed tomography (CAT) scan Other imaging scans, as needed Electrocardiogram (EKG) Tumor biopsy, if needed Laparoscopy. Small cuts will be made in the abdomen. A tube with a light and a camera will be used to see their organs. Some screening tests will be repeated in the study. Participants will enroll in NIH protocol #13C0176. This allows their tumor samples to be used in future research. Participants will have CRS. As many of their visible tumors will be removed as possible. They will also have HIPEC. Two thin tubes will be put in their abdomen. They will get chemotherapy through one tube. It will be drained out through the other tube. They will be in the hospital for 7-21 days after surgery. Participants will give tumor, blood, and fluid samples for research. They will complete surveys about their health and quality of life. Participants will have follow-up visits over 5 years...."
Research Center: National Institutes of Health Clinical Center
Treatment Interventions: DRUG: Mitomycin C|DRUG: Cisplatin, PROCEDURE: Heated Intraperitonial Chemotherapy, DRUG: 5-Fluorouracil, DRUG: Sodium Thiosulfate, DRUG: Doxorubicin, DRUG: Oxaliplatin
Potential Impact: Low
Clinical Trial Number: NCT04847063
Phase: Phase 1
Status: Recruiting
