Full dose S-1 monotherapy compared to reduced dose S-1/oxaliplatin combination therapy as first-line treatment for older patients with metastatic colorectal cancer - Nordic 9

Odense University Hospital0 个研究点目标入组 150 人开始时间: 2014年4月25日最近更新: 2014年10月27日

适应症

试验速览

暂无简介。

•Age = 70 years
•Histologically verified colorectal adenocarcinoma
•Non-resectable mCRC (ESMO group 2 or 3).
•NOT fit for full dose standard combination chemotherapy as considered by the treating physican.
•Measurable or non-measurable disease.
•Performance status (WHO) of 0-2 and a life expectancy of at least 3 months.
•No prior chemotherapy except adjuvant fluoropyrimidine therapy completed more than 180 days before randomization.
•Adequate haematological function defined as ANC ? 1.5 x 109/l and platelets = 100 x 109/l.
•Adequate organfunction (bilirubin = 1.5 x UNL (upper normal limit), GFR (may be calculated) > 30 ml/min.
•Written informed consent must be obtained according to the local Ethics Committee requirements.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•Prior history of cancer, except cervix in situ carcinoma, in situ urothelial carcinoma or previously treated and cured skin basocellular, and any other cancer in complete remission for at least 2 years.
•Any other condition or therapy, which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives.

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