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 160 人开始时间: 2014年3月5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 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 160

•Prior history of cancer, except cervix in situ carcinoma, in situ urothelial carcino-ma 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, uncon-trolled 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 ade-nocarcinoma 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 random-ised in the willing arm or patients who cannot be regularly followed up for psy-chological, 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