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

Enrolling by invitation · Not applicable

Conditions studied: Metastatic Colorectal Carcinoma (mCRC)

In brief

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.

Key facts

Study ID

NCT07334587

Run by

Allama Iqbal Medical College

People needed

248

Starts

2025-09-01

Expected to finish

2026-02-28

Last updated by the study team

2026-01-12

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Allama Iqbal Medical College, Lahore — Lahore, Punjab Province, Pakistan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.