Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07334587

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Metastatic Colorectal Carcinoma (mCRC) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allama Iqbal Medical College, Lahore

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Fluoropyrimidine-based chemotherapy with platinum compound

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.

Other names: Oxaliplatin-based infusional fluoropyrimidine chemotherapy regimen

Primary outcomes

  1. Disease progression

    Time frame: Within 3 months after initiation of assigned chemotherapy regimen

    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.

Secondary outcomes

  1. Hepatotoxicity

    Time frame: ithin 3 months after initiation of assigned chemotherapy regimen

    Hepatotoxicity will be defined as alanine aminotransferase and aspartate aminotransferase levels greater than two times the upper limit of normal and/or total bilirubin level greater than 5 milli-international units, occurring during follow-up, as per operational definition.

  2. Diarrhea

    Time frame: Within 3 months after initiation of assigned chemotherapy regimen

    Diarrhea will be defined as loose, watery stools persisting for more than 3 days during the follow-up period.

  3. Discontinuation of chemotherapy

    Time frame: Within 3 months after initiation of assigned chemotherapy regimen

    Permanent stopping of the assigned chemotherapy regimen due to severe adverse effects during the follow-up period.

  4. All-cause mortality

    Time frame: Within 3 months after initiation of assigned chemotherapy regimen

    Death from any cause occurring during the 3-month follow-up period after initiation of chemotherapy.

Sponsors and collaborators

Lead sponsor

Allama Iqbal Medical College

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.