Maintenance treatment with capecitabine and bevacizumab versus observation after induction treatment with capecitabine, oxaliplatin, and bevacizumab as first-line treatment in patients with advanced colorectal carcinoma, a randomised phase III study (CAIRO3 study) - CAIRO3

Dutch Colorectal Cancer Group0 个研究点开始时间: 2006年12月12日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•-Histological proof of CRC;
•-Advanced disease not amenable to surgery. No prior systemic treatment for advanced disease;
•-Distant metastases;
•-Unidimensionally measurable disease;
•-In case of previous radiotherapy, at least one measurable lesion located outside irradiated field
•-Prior adjuvant treatment for stage II/III colorectal cancer is allowed if last chemotherapy was given > 6 months before the start of induction treatment;
•-Age 18 years and above;
•-CT scan thorax and abdomen performed = 4 weeks prior to the start of induction treatment;
•-Negative pregnancy test in women with childbearing potential.
•- At least stable disease at the end of the induction phase.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•-CNS metastases;
•-History of a second malignancy = 5 years with the exception of adequately treated carcinoma of cervix or basal/squamous cell carcinoma of skin;
•-Previous intolerance of capecitabine, oxaliplatin, and/or bevacizumab for which any of these drugs have been permanently discontinued;
•-Known dihydropyrimidine dehydrogenase (DPD) deficiency;
•-(Planned) radical resection of all metastatic disease;
•-Uncontrolled hypertension;
•-Use of >3 antihypertensive drugs;
•-Significant cardiovascular disease < 1 yr before randomisation;
•-Chronic active infection.

发起方

Dutch Colorectal Cancer Group