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Enrolling by invitation NCT07334587

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

No phase Interventional Metastatic Colorectal Carcinoma (mCRC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Capecitabine and Oxaliplatin, Fluorouracil, Leucovorin Calcium, and Oxaliplatin.
Who it may be relevant to
Registry conditions: Metastatic Colorectal Carcinoma (mCRC). Basic parameters: 20 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Drug 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.
  • 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.

Primary outcome measures

  • Disease progression [Time frame: Within 3 months after initiation of assigned chemotherapy regimen]
Secondary outcome measures (4)
  • Hepatotoxicity [Time frame: ithin 3 months after initiation of assigned chemotherapy regimen]
  • Diarrhea [Time frame: Within 3 months after initiation of assigned chemotherapy regimen]
  • Discontinuation of chemotherapy [Time frame: Within 3 months after initiation of assigned chemotherapy regimen]
  • All-cause mortality [Time frame: Within 3 months after initiation of assigned 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Allama Iqbal Medical College, Lahore — Lahore

Identifiers

NCT: NCT07334587 · AllamaIqbalMC1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗