Abstract
BackgroundPeritoneal carcinomatosis is regarded as a common sign of advanced tumor stage, tumor progression or local recurrence of appendiceal and colorectal cancer and is generally associated with poor prognosis. Although survival of patients with advanced stage CRC has markedly improved over the last 20 years with systemic treatment, comprising combination chemotherapy +/− monoclonal antibodies, the oncological outcome—especially of the subgroup of patients with peritoneal metastases—is still unsatisfactory. In addition to systemic therapy, cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) are specific treatment options for a selected group of these patients and may provide an additional therapeutic benefit in the framework of an interdisciplinary treatment concept.Methods/designThe COMBATAC trial is a prospective, multicenter, open-label, single-arm, single-stage phase II trial investigating perioperative systemic polychemotherapy including cetuximab in combination with CRS and HIPEC patients with histologically proven wild-type KRAS colorectal or appendiceal adenocarcinoma and synchronous or metachronous peritoneal carcinomatosis. The planned total number of patients to be recruited is 60. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS), perioperative morbidity and treatment-associated toxicity, feasibility of the combined treatment regimen, quality of life (QoL) and histopathological regression after preoperative chemotherapy.DiscussionThe COMBATAC trial is designed to evaluate the feasibility and efficacy of the combined multidisciplinary treatment regimen consisting of perioperative systemic combination chemotherapy plus cetuximab and CRS plus bidirectional HIPEC with intraperitoneal oxaliplatin.Trial registrationClinicalTrials.gov Identifier: NCT01540344, EudraCT number: 2009-014040-11
Highlights
Peritoneal carcinomatosis is regarded as a common sign of advanced tumor stage, tumor progression or local recurrence of appendiceal and colorectal cancer and is generally associated with poor prognosis
The COMBATAC trial is designed to evaluate the feasibility and efficacy of the combined multidisciplinary treatment regimen consisting of perioperative systemic combination chemotherapy plus cetuximab and cytoreductive surgery (CRS) plus bidirectional hyperthermic intraperitoneal chemotherapy (HIPEC) with intraperitoneal oxaliplatin
Whereas the mortality associated with Colorectal cancer (CRC) slightly decreased over the past 20 years the incidence is still increasing in most countries [1,2]
Summary
Peritoneal carcinomatosis is regarded as a common sign of advanced tumor stage, tumor progression or local recurrence of appendiceal and colorectal cancer and is generally associated with poor prognosis. Up to 25% of all patients with CRC develop peritoneal carcinomatosis during the natural course of their disease as a common sign of tumor progression or recurrence. In the prospective European multicenter EVOCAPE 1 study, a median survival of 5.2 months was reported out of the 118 patients with peritoneal carcinomatosis arising from CRC during the natural course of disease [10]. Another retrospective analysis of 3,000 patients with peritoneal colon cancer dissemination reported a comparable median survival of 7 months [11]
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