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

NCT07334587 | Enrolling By Invitation

• 1 other identifier: AllamaIqbalMC1
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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)

Keywords

Oxaliplatin; Metastatic colorectal cancer; Fluorouracil; Antineoplastic combined chemotherapy; Capecitabine

Outcome Measures

Primary Outcomes (1)

• Disease progression

  Disease progression will be defined as an increase in lesion size and/or development of new symptoms consistent with worsening metastatic colorectal carcinoma, assessed clinically and by available follow-up evaluation during the follow-up period, as per the study operational definition.

  Within 3 months after initiation of assigned chemotherapy regimen

Secondary Outcomes (4)

• Hepatotoxicity

  ithin 3 months after initiation of assigned chemotherapy regimen

• Diarrhea

  Within 3 months after initiation of assigned chemotherapy regimen

• Discontinuation of chemotherapy

  Within 3 months after initiation of assigned chemotherapy regimen

• All-cause mortality

  Within 3 months after initiation of assigned chemotherapy regimen

Study Arms (2)

Group CAPOX

EXPERIMENTAL

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

Drug: Capecitabine and Oxaliplatin

Group FOLFOX-6

ACTIVE COMPARATOR

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

Drug: Fluorouracil, Leucovorin Calcium, and Oxaliplatin

Interventions

Capecitabine and Oxaliplatin 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.

Also known as: Fluoropyrimidine-based chemotherapy with platinum compound

Group CAPOX

Fluorouracil, Leucovorin Calcium, and Oxaliplatin 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.

Also known as: Oxaliplatin-based infusional fluoropyrimidine chemotherapy regimen

Group FOLFOX-6

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allama Iqbal Medical College: lead

Study Sites (1)

Allama Iqbal Medical College, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine; Oxaliplatin; Platinum Compounds; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Inorganic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Parnia Ansari

  Allama Iqbal Medical College, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: September 1, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

PA (1)