Comparison of Efficacy and Safety Between FOLFOX-6 and CAPOX in Metastatic Colorectal Carcinoma

NCT ID: NCT07334587

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-02-28

Brief Summary

This randomized controlled trial is designed to compare the efficacy and safety of two commonly used chemotherapy regimens, FOLFOX-6 and CAPOX, in adults with metastatic colorectal carcinoma who are receiving chemotherapy after surgery at the Department of Oncology, Jinnah Hospital, Lahore. A total of 248 eligible patients aged 20 to 70 years will be enrolled using consecutive sampling and randomly allocated in equal numbers to receive either CAPOX or FOLFOX-6 according to standard dosing schedules. Participants will be followed for 3 months to determine whether meaningful differences exist between the two regimens in clinically important outcomes. The primary comparison will focus on disease progression within the follow-up period. Additional safety and treatment feasibility outcomes will include the need for chemotherapy dose reduction due to toxicity, treatment discontinuation, hepatotoxicity based on liver function abnormalities, diarrhea persisting for more than 3 days, and mortality during follow-up. The study hypothesis is that the outcomes of FOLFOX-6 and CAPOX differ in terms of effectiveness and adverse effects. The findings are expected to inform selection of a regimen that provides better disease control with fewer treatment-limiting side effects in the local clinical setting.

Conditions

Metastatic Colorectal Carcinoma (mCRC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group CAPOX

Participants will receive combination chemotherapy with capecitabine and oxaliplatin following standard dosing schedule after surgical management of metastatic colorectal carcinoma.

Group Type: EXPERIMENTAL

Capecitabine and Oxaliplatin

Intervention Type: DRUG

Oxaliplatin 130 mg per square meter administered intravenously on Day 1, together with oral capecitabine 1000 mg per square meter every 12 hours from Day 1 to Day 14.

The treatment cycle will be repeated every 21 days for 6 to 8 cycles.

Group FOLFOX-6

Participants will receive combination chemotherapy with fluorouracil, leucovorin calcium, and oxaliplatin following standard FOLFOX-6 protocol after surgical management of metastatic colorectal carcinoma.

Group Type: ACTIVE_COMPARATOR

Fluorouracil, Leucovorin Calcium, and Oxaliplatin

Intervention Type: DRUG

Oxaliplatin 85 mg per square meter administered intravenously, leucovorin calcium 400 mg per square meter intravenous infusion, followed by fluorouracil bolus and continuous fluorouracil infusion over 46 hours at a dose of 2400 mg per square meter.

The regimen will be repeated every 14 days for 12 cycles.

Interventions

Capecitabine and Oxaliplatin

Oxaliplatin 130 mg per square meter administered intravenously on Day 1, together with oral capecitabine 1000 mg per square meter every 12 hours from Day 1 to Day 14.

The treatment cycle will be repeated every 21 days for 6 to 8 cycles.

Intervention Type: DRUG

Fluorouracil, Leucovorin Calcium, and Oxaliplatin

Oxaliplatin 85 mg per square meter administered intravenously, leucovorin calcium 400 mg per square meter intravenous infusion, followed by fluorouracil bolus and continuous fluorouracil infusion over 46 hours at a dose of 2400 mg per square meter.

The regimen will be repeated every 14 days for 12 cycles.

Intervention Type: DRUG

Other Intervention Names

Fluoropyrimidine-based chemotherapy with platinum compound; Oxaliplatin-based infusional fluoropyrimidine chemotherapy regimen

Eligibility Criteria

Inclusion Criteria

• Patients aged 20-70 years,
• Both genders,
• Diagnosed with metastatic colorectal carcinoma, receiving chemotherapy after surgery.

Exclusion Criteria

• Patients with non-metastatic disease at the time of diagnosis, coexisting other malignancy, and administration of adjuvant chemotherapy in an external center
• Patients with a history of neurologic disease (as per medical record)
• Patients already taking trial treatment or enrolled in another trial

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allama Iqbal Medical College

OTHER

Sponsor Role: lead

Responsible Party

Parnia Ansari

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Parnia Ansari

Role: PRINCIPAL_INVESTIGATOR

Allama Iqbal Medical College, Lahore

Locations

Allama Iqbal Medical College, Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

AllamaIqbalMC1

Identifier Type: -

Identifier Source: org_study_id