Full dose monotherapy S-1 (followed by irinotecan) compared to reduced dose combination therapy (S-1/oxaliplatin followed by S-1/irinotecan) as initial therapy for older patients with metastatic colorectal cancer - Nordic 9

Odense University Hospital0 个研究点目标入组 160 人开始时间: 2014年11月24日最近更新: 2022年4月4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 a candidate for standard full-dose 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 10^9/l and platelets = 100 x 10^9/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.
•No current indication for resection with a curative intent;
•No evidence of CNS metastasis;
•No current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis;
•No current history of chronic diarrhoea;
•No peripheral neuropathy;
•No other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months);
•No past or concurrent history of malignant neoplasm other than colorectal adenocarcinoma within the past five years, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix;
•No concurrent treatment with any other anti-cancer therapy; Fertile patients must use adequate contraceptives
•Not include patients clearly intending to withdraw from the study if not randomised in the willing arm or patients who cannot be regularly followed up for psychological, social, familiar or geographic reasons.
•Any other condition or therapy, which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives.
•Known allergy to any of the drugs used in NORDIC 9 (S-1, oxaliplatin, irinotecan, bevacizumab).

发起方