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

BMC Cancer

Study Protocol

Florian Zeman¹  Michael Koller¹  Frank Klebl²  Dirk Arnold³  Sven A Lang⁴  Gabriel Glockzin⁴  Hans J Schlitt⁴  Pompiliu Piso⁵  Justine Rochon⁶ 

[1] Center for Clinical Studies, University Medical Center Regensburg, Regensburg, Germany;Department of Internal Medicine, University Medical Center Regensburg, Regensburg, Germany;Department of Medical Oncology, Tumor Biology Clinic, Albert Ludwigs University, Freiburg, Germany;Department of Surgery, University Medical Center Regensburg, 93042, Regensburg, Germany;Department of Surgery, University Medical Center Regensburg, 93042, Regensburg, Germany;Department of Surgery, St. John of God Hospital Regensburg, Regensburg, Germany;Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany;

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

DOI  :  10.1186/1471-2407-13-67

 received in 2012-11-12, accepted in 2013-02-04,  发布年份 2013

来源: Springer

【 摘 要 】

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

【 授权许可】

CC BY   
© Glockzin et al.; licensee BioMed Central Ltd. 2013