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: 20.0Level: 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-DK
- 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 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).
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 (TFS)<br>Overall survival (OS)<br>Response rate (RR) according to RECIST criteria version 1.1<br>Toxicity<br>EORTC QLQ-C30<br>”Easy Geriatric Assessment” (Barthel-index, Timed Up and Go (TUG) and Grip Strength, Co-morbidity (Charlson index)<br>Comprehensive Geriatric Assessment in selected patients/institutions<br>Correlation between tumormarkers and outcome<br>;Primary end point(s): Progression-free survival ;Timepoint(s) of evaluation of this end point: 50 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Overall survival <br>Toxicity;Timepoint(s) of evaluation of this end point: 50 months<br>50 months