Metastatic colorectal cancer Male or female > 65 years of age frail patients
Conditions
Interventions
Arm A:
UFT 300 mg/m2 orally, divided in two daily doses, days 1-28
Leucovorin: 60 mg/day orally, divided in two daily doses, days 1-28,
Q5 weeks, until disease progression or unacceptable toxicity
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent 2. Male or female > 65 years of age 3. Histologically proven advanced CRC; not amenable for curative surgery 4. Life expectancy of > 3 months 5. Unwilling or unfit (in the opinion of the investigator) for combination therapy 6. WHO performance status 0 - 2 7. Neutrophils > 1.5x109/L, platelets > 100x109/L, and Hb > 6 mmol/l 8. Bilirubin level 60 cc/min 11. Expected adequacy of follow-up.
Exclusion criteria
Exclusion criteria: 1. Prior chemotherapy for advanced CRC; prior adjuvant chemotherapy is allowed provided that the last administration was given > 6 months prior to randomization. 2. Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry 3. In case of previous radiotherapy at least one measurable lesion located outside the irradiated field. 4. Any investigational agent(s) within 4 weeks prior to entry 5. Treatment with brivudine within 1 month 6. Central nervous system metastasis (known or suspected) 7. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix. 8. Known hypersensitivity reaction to any of the components of the treatment 9. Known drug abuse/ alcohol abuse 10. Partial or complete bowel obstruction 11. Chronic diarrhoea or inflammatory bowel disease 12. Known DPD deficiency 13. Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia 14. Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent     
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| -Quality adjusted survival -Overall survival -Delivered dose intensity -Safety -Geriatric questionnaires -Translational research | — |
Contacts
Public ContactJ.R. Kroep
Intenist -oncoloog Department of Clinical Oncology postzone K-1P
Outcome results
None listed