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

URN to cite this document:

urn:nbn:de:bvb:355-epub-287742 Copy

DOI to cite this document:

10.5283/epub.28774 Copy

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

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Date of publication of this fulltext: 03 Sep 2013 07:30

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Details

Item type:	Article
Open Access Type:	Gold (with APC)
Journal or Publication Title:	BMC Cancer
Publisher:	BMC
Volume:	13
Page Range:	p. 67
Date:	2013
Institutions:	Medicine > Lehrstuhl für Chirurgie
Identification Number:	Value Type 23391248 PubMed ID 10.1186/1471-2407-13-67 DOI
Classification:	Notation Type Adenocarcinoma/therapy MESH Antineoplastic Combined Chemotherapy Protocols/therapeutic use MESH Appendiceal Neoplasms/therapy MESH Chemotherapy, Adjuvant MESH Chemotherapy, Cancer, Regional Perfusion/adverse effects MESH Colorectal Neoplasms/therapy MESH Digestive System Surgical Procedures/adverse effects MESH Disease-Free Survival MESH Feasibility Studies MESH Germany MESH Humans MESH Hypothermia, Induced/adverse effects MESH Metastasectomy/adverse effects MESH Peritoneal Neoplasms/therapy MESH Prospective Studies MESH Proto-Oncogene Proteins/genetics MESH Quality of Life MESH Research Design MESH Sample Size MESH Time Factors MESH Treatment Outcome MESH ras Proteins/genetics MESH
Keywords:	Cytoreductive surgery, HIPEC, Perioperative chemotherapy, Cetuximab, Colorectal cancer, Peritoneal carcinomatosis
Dewey Decimal Classification:	600 Technology > 610 Medical sciences Medicine
Status:	Published
Refereed:	Yes, this version has been refereed
Created at the University of Regensburg:	Yes
Item ID:	28774

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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 ...

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

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Metadata last modified: 29 Sep 2021 07:39

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