期刊
BMC CANCER
卷 14, 期 -, 页码 -出版社
BMC
DOI: 10.1186/1471-2407-14-741
关键词
Stage IV colorectal cancer; Unresectable metastases; Synchronous metastases; Palliative chemotherapy; Bevacizumab; Primary tumour; Surgical resection
类别
资金
- Dutch Colorectal Cancer Group
- Commissie voor Klinisch Toegepast Onderzoek (Committee for Clinical Research) of the Dutch Cancer Foundation [CKTO: 2012-5697]
- Hoffmann-La Roche Ltd, Switzerland
Background: There 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/design: The 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. Discussion: The 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.
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