Full dose S1 compared to reduced dose S-1/oxaliplatin. First-line treatment for older patients with metastic colorectal cancer.
- Conditions
- Treatment of older (= 70 years) patients with metastatic colorectal cancerMedDRA version: 17.1Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-000394-39-FI
- Lead Sponsor
- Odense University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
•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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Progression-free survival (PFS);Secondary Objective: Time-to failure of strategy (TTFS)<br>Overall survival (OS)<br>Response rate (RR) according to RECIST criteria version 1.1<br>Toxicity<br>EORTC QLQ-C30<br>Correlation between tumourmarkers and outcome<br>Evaluation of pre-treatment characteristics (performance status and Simple Geriatric Assessment) as predictive markers for efficacy and toxicity <br><br>;Primary end point(s): Progression-free survival ;Timepoint(s) of evaluation of this end point: 30 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Overall survival <br>Toxicity;Timepoint(s) of evaluation of this end point: 30 months<br>30 months