A prospective multicenter phase II study evaluating multimodality treatment of patients with peritoneal carcinomatosis arising from appendiceal and colorectal cancer: the COMBATAC trial
Creators: name: Glockzin, Gabriel
name: Rochon, Justine
name: Arnold, Dirk
name: Lang, Sven A.
name: Klebl, Frank
name: Zeman, Florian
name: Koller, Michael
name: Schlitt, Hans J.
name: Piso, Pompiliu
Publisher: name: Universität Regensburg
Year: 2013
Subjects: subject: QUALITY-OF-LIFE; HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY; CETUXIMAB PLUS IRINOTECAN; 1ST-LINE TREATMENT; CYTOREDUCTIVE SURGERY; RANDOMIZED-TRIAL; SYSTEMIC CHEMOTHERAPY; INFUSIONAL FLUOROURACIL; ORAL FLUOROPYRIMIDINES; TISSUE DISTRIBUTION; Cytoreductive surgery; HIPEC; Perioperative chemotherapy; Cetuximab; Colorectal cancer; Peritoneal carcinomatosis
subject: 610 Medizin
subject: Adenocarcinoma/therapy
subject: Antineoplastic Combined Chemotherapy Protocols/therapeutic use
subject: Appendiceal Neoplasms/therapy
subject: Chemotherapy, Adjuvant
subject: Chemotherapy, Cancer, Regional Perfusion/adverse effects
subject: Colorectal Neoplasms/therapy
subject: Digestive System Surgical Procedures/adverse effects
subject: Disease-Free Survival
subject: Feasibility Studies
subject: Germany
subject: Humans
subject: Hypothermia, Induced/adverse effects
subject: Metastasectomy/adverse effects
subject: Peritoneal Neoplasms/therapy
subject: Prospective Studies
subject: Proto-Oncogene Proteins/genetics
subject: Quality of Life
subject: Research Design
subject: Sample Size
subject: Time Factors
subject: Treatment Outcome
subject: ras Proteins/genetics

description: 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.