EFFIPEC Forskningsprogram (Efficacy of HIPEC): En fas I och en open-label fas III studie på kolorektal cancer med peritoneala metastaser
Tidsperiod: 2020-12-01 till 2024-12-31
Projektledare: Peter Cashin
Medarbetare: Ingvar Syk, Gabriella Jansson Palmer, Dan Asplund, Lana Ghanipour
Bidragstyp: Stöd till forskningsmiljö
Budget: 7 730 308 SEK
Background, Population and Aim: To increase the cure rate from colorectal cancer, more effective treatments for metastatic disease are needed. Metastases to the peritoneum is a common and difficult clinical situation with poor systemic chemotherapy effect. Cytoreductive surgery (CRS) is the standard surgical treatment when the disease is resectable; however, it is unknown whether the use of hyperthermic intraperitoneal chemotherapy (HIPEC) or early postoperative intraperitoneal chemotherapy (EPIC) improves survival. No consensus globally exists for these treatments. Furthermore, there are patients not benefiting from these treatments that need to be identified in order to investigate alternative treatment options. We aim to investigate the effect of intensified triple-drug HIPEC+EPIC treatment.Intervention: A national phase 1 and an open-label phase 3 randomized trial with an interventional arm using CRS + triple-drug HIPEC+EPIC.Control: The control arm is the current standard in Sweden, CRS + single-drug HIPEC. Chemotherapy resistance testing will investigate whether it is possible to identify patients that may not benefit from the treatments.Outcome and Impact: The primary outcome is recurrence-free survival. Secondary outcomes are morbidity, quality-of-life, and identification of patients not benefiting from treatment intensification. This trial anticipates a significant positive impact on survival for colorectal cancer with peritoneal metastases.