Chemotherapy with Camptothecin-11 (CPT-11), Fluorouracil (5FU), folinic acid and oxaliplatin in patients with metastatic colorectal cancer

Interventions: CPT-11+ Folinic Acid+ 5FU weekly for 6 weeks on days 1,8,15,22,29 and 36 (followed by 2 weeks rest for a total cycle duration of 8 weeks) at the following doses:
CPT-11: 80 mg/m2 in 250 ml normal saline intravenous injection (IV) over 90 minutes
Folinic acid: 200 mg/m2 in 500 ml normal saline IV over 2 hours
5FU: 450 mg/m2 IV bolus.
This 8-week cycle will be administered in an identical manner again (i.e. total 16 weeks).
Then, it will be followed by Oxaliplatin+ Folinic Acid+ 5FU weekly for 6 weeks on days 1,8,15,22,29 and 36 (followed by 2 weeks rest for a total cycle duration of 8 weeks) at the following doses:
Oxaliplatin: 45 mg/m2 IV over a 90 min infusion
Folinic acid: 200 mg/m2 in 500 ml normal saline IV over 2 hours
5FU: 450 mg/m2 IV bolus
This 8-week cycle will be administered in an identical manner again (i.e. total 16 weeks).
The overall duration of the intervention will be 32 weeks in total (4 cycles).
Primary outcome(s): Objective Response Rate (ORR).
The ORR will be assessed by imaging methods including computed tomography (CT) scan, bone scan, X-ray etc.[At 32 months from study initiation]
Study Design: Purpose: Treatment; Allocation: Randomised controlled trial