The CAIRO4 study: the role of surgery of the primary tumour with few or absent symptoms in patients with synchronous unresectable metastases of colorectal cancer – a randomized phase III study of the Dutch Colorectal Cancer GrouReportar como inadecuado




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BMC Cancer

, 14:741

Clinical oncology

Abstract

BackgroundThere is no consensus regarding resection of the primary tumour with few or absent symptoms in patients with synchronous unresectable metastatic colorectal cancer CRC. A potential benefit of resection of the primary tumour is to prevent complications of the primary tumour in later stages of the disease. We here propose a randomized trial in order to demonstrate that resection of the primary tumour improves overall survival.

Methods-designThe CAIRO4 study is a multicentre, randomized, phase III study of the Dutch Colorectal Cancer Group DCCG. Patients with synchronous unresectable metastases of CRC and few or absent symptoms of the primary tumour are randomized 1:1 between systemic therapy only, and resection of the primary tumour followed by systemic therapy. Systemic therapy will consist of fluoropyrimidine-based chemotherapy in combination with bevacizumab. The primary objective of this study is to determine the clinical benefit in terms of overall survival of initial resection of the primary tumour. Secondary endpoints include progression free survival, surgical morbidity, quality of life and the number of patients requiring resection of the primary tumour in the control arm.

DiscussionThe CAIRO4 study is a multicentre, randomized, phase III study that will assess the benefit of resection of the primary tumour in patients with synchronous metastatic CRC.

Trial registrationThe CAIRO4 study is registered at clinicaltrials.gov NCT01606098

KeywordsStage IV colorectal cancer Unresectable metastases Synchronous metastases Palliative chemotherapy Bevacizumab Primary tumour Surgical resection Abbreviations5FU-LVFluorouracil-leucovorin

CAPIRICapecitabine-irinotecan

CAPOXCapecitabine-oxaliplatin

CEACarcinoembryotic antigen

CRCColorectal cancer

CTComputed tomography

EORTCEuropean Organisation for Research and Treatment of Cancer

FOLFIRILeucovorin folinic acid-fluorouracil-irinotecan

FOLFOXLeucovorin folinic acid-fluorouracil-oxaliplatin

LDHLactate dehydrogenase

MRIMagnetic resonance imaging

NCINational Cancer Institute

PETPositron emission tomography

QLQQuality of life questionnaire

RECISTResponse evaluation criteria in solid tumours

ULNUpper limit of normal

VEGFVascular endothelial growth factor

WHOWorld Health Organisation.

and Miriam Koopman contributed equally to this work.

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