Treatment of older (= 70 years) patients with metastatic colorectal cancer MedDRA version: 20.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Oxaliplatin
Product Name: oxaliplatin
Product Code: 23388
Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion
INN or Proposed INN: OXALIPLATIN
CAS Number: 6182
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression-free survival (PFS);Secondary Objective: Time-to failure of strategy (TFS) Overall survival (OS) Response rate (RR) according to RECIST criteria version 1.1 Toxicity EORTC QLQ-C30 ”Easy Geriatric Assessment” (Barthel-index, Timed Up and Go (TUG) and Grip Strength, Co-morbidity (Charlson index) Comprehensive Geriatric Assessment in selected patients/institutions Correlation between tumormarkers and outcome ;Primary end point(s): Progression-free survival ;Timepoint(s) of evaluation of this end point: 50 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival Toxicity;Timepoint(s) of evaluation of this end point: 50 months 50 months | — |
Countries
Denmark, Finland, Norway
Contacts
Public ContactStine Brændegaard Winther
Odense University Hospital
Outcome results
None listed