undergone R0-resection of for colon cancer stage III
Conditions
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Radical surgery (R0/R1) for colon cancer · Histologically verified adenocarcinoma of the colon · Histologically verified lymph node metastases (Stage III) · Age = 75 years · Able to undergo ambulatory treatment (adequate physical and mental function) · Lab values as the following: - absolute neutrophil count ³1.5 x 109/L - platelet count ³100 x 109/L - clinically acceptable haemoglobin levels - creatinine levels indicating renal clearance of ³30 ml/min - bilirubin =1.5 x UNL (upper normal limit) · Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP and national regulations. 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 170
Exclusion criteria
Exclusion criteria: · Distant metastases (stage IV) · Frail according to geriatric assessment · Significant cardiovascular disease (congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia) or myocardial infarction within the past 12 months · Previous treatment with chemotherapy for colorectal cancer · Metastatic disease from other cancer · Reduced cognitive function not enabling ability to give informed consent or compliance with the study · History of prior or concurrent 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 · Adverse reactions to capecitabine or related drugs. Need to use medications contraindicated according to SmPC of the IMP(s), such as sorivudin, brivudin or chemically related compounds. Any other contraindication listed on the SmPC of the IMP(s) · Use of methotrexate or other cytotoxic drugs as treatment of rheumatoid arthritis or other inflammatory disease and where it is considered contraindicated to stop this medication · Known DPD deficiency · Any reason why, in the opinion of the investigator, the patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to investigate the tolerance of adjuvant chemotherapy, measured by functional decline, after surgery for colon cancer stage III in elderly patients. ;Secondary Objective: Secondary aims are disease-free survival, toxicity, late functional outcome, quality of life, to establish a geriatric assessment for selection of patients, and to examine the prognostic value of gene signature tests / biomarkers for stage III colon cancer. ;Primary end point(s): The primary endpoint is to investigate tolerance of adjuvant chemotherapy in elderly patients, measured as functional decline or independency. This will be measured by activities of daily living (ADL) and instrumental activities of daily living (IADL) scales;Timepoint(s) of evaluation of this end point: The primary endpoint is the proportion of patients experiencing a functional decline in IADL or ADL one year after surgery. Functional decline is defined as a decline on any item on either scale, i.e. a reduction of at least one point in IADL or 5 points in ADL | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are compliance with adjuvant chemotherapy, toxicity of chemotherapy, quality of life, disease-free and overall survival, and validation of the performance of prognostic biomarkers in estimating disease-free survival.;Timepoint(s) of evaluation of this end point: Functional status and quality of life 6 and 12 months after operation | — |
Countries
Norway
Contacts
Public ContactMarianne G. Guren
Oslo University Hospital
Outcome results
None listed