Multimodality Treatment Including Pre- and Postoperative Systemic Chemotherapy Plus Cetuximab, Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis Arising From Wild Type K-ras Colon Cancer: A Prospective Multicenter Phase II Study.
More than 10% of patients with colorectal cancer (CRC) already show peritoneal
carcinomatosis at the time of initial diagnosis and up to 25% of all patients develop
peritoneal carcinomatosis during the natural course of their disease as a common sign of
tumor progression or recurrence.
The existing data suggests that CRS and HIPEC as an integral part of a multidisciplinary
treatment concept may improve long-term survival of selected patients with peritoneal
carcinomatosis of colonic origin. Moreover, hyperthermic peritoneal perfusion with
oxaliplatin in combination with synchronous application of 5-FU/leucovorin seems to improve
the efficacy of HIPEC in comparison to a mitomycin C-based intraperitoneal treatment regimen
and may lead to a better local tumor control. The improved systemic treatment strategy with
neoadjuvant chemotherapy may lead to increased rates of complete macroscopic cytoreduction
and together with the adjuvant treatment to better control of distant metastasis and tumor
recurrence. However, there is no prospective study available evaluating the clinical and
oncological outcome after standard-of-care chemotherapy including targeted anticancer
therapy in combination with CRS and HIPEC. The published morbidity and mortality rates after
CRS and HIPEC are comparable to other major gastrointestinal surgery and seem to be
acceptable considering the expected improvement of oncological outcome.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS)
Pompiliu Piso, Prof. MD
University of Regensburg
Germany: Federal Institute for Drugs and Medical Devices