A prospective multicenter phase II study evaluating multimodality treatment of patients with peritoneal carcinomatosis arising from appendiceal and colorectal cancer: ... View Full Text


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Article Info

DATE

2013-02-07

AUTHORS

Gabriel Glockzin, Justine Rochon, Dirk Arnold, Sven A Lang, Frank Klebl, Florian Zeman, Michael Koller, Hans J Schlitt, Pompiliu Piso

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. More... »

PAGES

67-67

References to SciGraph publications

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  • 2012-03-07. The Treatment of Peritoneal Carcinomatosis of Colorectal Cancer with Complete Cytoreductive Surgery and Hyperthermic Intraperitoneal Peroperative Chemotherapy (HIPEC) with Oxaliplatin: A Belgian Multicentre Prospective Phase II Clinical Study in ANNALS OF SURGICAL ONCOLOGY
  • 2004-01-20. Improved survival in patients with peritoneal metastases from colorectal cancer: a preliminary study in BRITISH JOURNAL OF CANCER
  • 2003-09-01. Intraperitoneal Chemohyperthermia Using a Closed Abdominal Procedure and Cytoreductive Surgery for the Treatment of Peritoneal Carcinomatosis: Morbidity and Mortality Analysis of 216 Consecutive Procedures in ANNALS OF SURGICAL ONCOLOGY
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  • 2004-05. Treatment of Peritoneal Carcinomatosis From Colorectal Cancer: Impact of Complete Cytoreductive Surgery and Difficulties in Conducting Randomized Trials in ANNALS OF SURGICAL ONCOLOGY
  • 2009-01-08. Peritoneal carcinomatosis: patients selection, perioperative complications and quality of life related to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in WORLD JOURNAL OF SURGICAL ONCOLOGY
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  • 2008-06-03. 8-Year Follow-up of Randomized Trial: Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Patients with Peritoneal Carcinomatosis of Colorectal Cancer in ANNALS OF SURGICAL ONCOLOGY
  • 2004-02. Cytoreductive Surgery and Intraperitoneal Hyperthermic Chemotherapy With Mitomycin C for Peritoneal Carcinomatosis from Nonappendiceal Colorectal Carcinoma in ANNALS OF SURGICAL ONCOLOGY
  • Journal

    TITLE

    BMC Cancer

    ISSUE

    1

    VOLUME

    13

    Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/1471-2407-13-67

    DOI

    http://dx.doi.org/10.1186/1471-2407-13-67

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1042747579

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/23391248


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