Randomized Phase 2 Study Comparing Second Look Laparoscopy to Standard Follow up in Patients With no Radiologic Evidence of Disease at 6 Months After Complete Resection of Colorectal Mucinous Carcinoma
Patients will be entered into the study after radical resection of mucinous colorectal
cancer, and reevaluated by CT scan after 6 months. Patients with no evidence of disease will
be randomized to receive either standard follow up, or to have a second look laparoscopy to
evaluate for peritoneal carcinosis. After laparoscopy, those patients who do not have
peritoneal carcinosis will continue with standard follow up. Patients with peritoneal
carcinosis diagnosed by laparoscopy will be treated according to their peritoneal carcinosis
index (PCI). For patients with PCI > 20, systemic chemotherapy will be given according to
Italian Association of Medical Oncology (AIOM) guidelines. Patients with PCI < 20 will
undergo peritonectomy and then receive intravenous chemotherapy immediately followed by
HIPEC.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall survival
two years
No
C. Sassaroli, M.D.
Principal Investigator
National Cancer Institute, Naples
Italy: Ethics Committee
HIPEC
NCT01628211
April 2012
June 2016
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