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Open Access Study protocol

A prospective multicenter phase II study evaluating multimodality treatment of patients with peritoneal carcinomatosis arising from appendiceal and colorectal cancer: the COMBATAC trial

Gabriel Glockzin1*, Justine Rochon2, Dirk Arnold3, Sven A Lang1, Frank Klebl4, Florian Zeman5, Michael Koller5, Hans J Schlitt1 and Pompiliu Piso16

Author Affiliations

1 Department of Surgery, University Medical Center Regensburg, Regensburg 93042, Germany

2 Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany

3 Department of Medical Oncology, Tumor Biology Clinic, Albert Ludwigs University, Freiburg, Germany

4 Department of Internal Medicine, University Medical Center Regensburg, Regensburg, Germany

5 Center for Clinical Studies, University Medical Center Regensburg, Regensburg, Germany

6 Department of Surgery, St. John of God Hospital Regensburg, Regensburg, Germany

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BMC Cancer 2013, 13:67  doi:10.1186/1471-2407-13-67

Published: 7 February 2013

Abstract

Background

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. 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/design

The 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.

Discussion

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 CRS plus bidirectional HIPEC with intraperitoneal oxaliplatin.

Trial registration

ClinicalTrials.gov Identifier: NCT01540344, EudraCT number: 2009-014040-11

Keywords:
Cytoreductive surgery; HIPEC; Perioperative chemotherapy; Cetuximab; Colorectal cancer; Peritoneal carcinomatosis