title: A prospective multicenter phase II study evaluating multimodality treatment of patients with peritoneal carcinomatosis arising from appendiceal and colorectal cancer: the COMBATAC trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01540344, EudraCT number: 2009-014040-11.
authors: Department of Surgery, University Medical Center Regensburg, Regensburg 93042, Germany. gabriel.glockzin@ukr.de
authors: Gabriel
authors: G
authors: Glockzin
authors: Justine
authors: J
authors: Rochon
authors: Dirk
authors: D
authors: Arnold
authors: Sven A
authors: SA
authors: Lang
authors: Frank
authors: F
authors: Klebl
authors: Florian
authors: F
authors: Zeman
authors: Michael
authors: M
authors: Koller
authors: Hans J
authors: HJ
authors: Schlitt
authors: Pompiliu
authors: P
authors: Piso
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000235:genetics / Q000556:secondary / Q000601:surgery / Q000628:therapy*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001063:Appendiceal Neoplasms / Q000188:drug therapy / Q000235:genetics / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D017024:Chemotherapy, Adjuvant; D010478:Chemotherapy, Cancer, Regional Perfusion / Q000009:adverse effects; D015179:Colorectal Neoplasms / Q000188:drug therapy / Q000235:genetics / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D013505:Digestive System Surgical Procedures / Q000009:adverse effects; D018572:Disease-Free Survival; D005240:Feasibility Studies; D005858:Germany; D006801:Humans; D007036:Hypothermia, Induced / Q000009:adverse effects; D059146:Metastasectomy / Q000009:adverse effects; D010534:Peritoneal Neoplasms / Q000188:drug therapy / Q000235:genetics / Q000556:secondary / Q000601:surgery / Q000628:therapy*; D011446:Prospective Studies; D011518:Proto-Oncogene Proteins / Q000235:genetics; D016283:Proto-Oncogene Proteins p21(ras); D011788:Quality of Life; D012107:Research Design; D018401:Sample Size; D013997:Time Factors; D016896:Treatment Outcome; D018631:ras Proteins / Q000235:genetics
chemical_list: C117307:KRAS protein, human; D011518:Proto-Oncogene Proteins; D016283:Proto-Oncogene Proteins p21(ras); D018631:ras Proteins
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