The COMBATAC study evaluates the the effect as assessed by progression-free survival (PFS) of perioperative systemic chemotherapy including cetuximab and cytoreductive surgery (CRS) and bidirectional hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal carcinomatosis arising from colorectal cancer.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Charité Campus Mitte, Humboldt-University Berlin
Berlin, Germany
Cologne-Merheim Medical Center, University Witten/Herdecke
Cologne, Germany
Medical Center of the Friedrich-Alexander-University Erlangen- Nürnberg
Erlangen, Germany
University Hospital Regensburg
Regensburg, Germany
Progression-free survival (PFS)
Time frame: 24 months
Overall survival (OS)
Time frame: 5 years
Feasibility of the combined treatment concept
Assessment of tumor progression, AE and SAE during treatment phase leading to modification or end of treatment.
Time frame: 9 months
Quality of life (QoL)
assessed by EORTC-QLQ-C30
Time frame: 2 years
Pathohistological regression
assessed by Dworak grade of regression in histology after surgery
Time frame: 16 weeks
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St. John of God Hospital Regensburg
Regensburg, Germany
University Hospital, University of Tuebingen
Tübingen, Germany
University Hospital Wuerzburg, Julius-Maximilians University
Würzburg, Germany