Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
The Nordic Colorectal Cancer Biomodulation Group
Age
18–74
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histology and staging disease:
Histological proven adenocarcinoma of the colon or rectum;
At least one measurable metastatic disease
If only one metastatic lesion and no S-CEA elevation, histology is mandatory;
Availability of tumour sample for EGFR assessment.
General conditions:
Age \>18 and \< 75 years;
WHO performance status: life expectancy of more than 3 months;
Adequate haematological function
Adequate renal and hepatic functions
Written informed consent
You may not be if
Prior therapy:
No prior chemotherapy for advanced/metastatic disease;
No adjuvant chemotherapy the last 6 months before inclusion;
No previous oxaliplatin;
Prior or current history:
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, contraindications to monoclonal antibodies);
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;
Concomitant treatments:
No concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation;
No concurrent treatment with any other anti-cancer therapy;
Other:
Not pregnant, no breast feeding
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.
