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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Disease progression [Срок оценки: Within 3 months after initiation of assigned chemotherapy regimen]

Вторичные конечные точки (4)

• Hepatotoxicity [Срок оценки: ithin 3 months after initiation of assigned chemotherapy regimen]
• Diarrhea [Срок оценки: Within 3 months after initiation of assigned chemotherapy regimen]
• Discontinuation of chemotherapy [Срок оценки: Within 3 months after initiation of assigned chemotherapy regimen]
• All-cause mortality [Срок оценки: Within 3 months after initiation of assigned chemotherapy regimen]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Allama Iqbal Medical College, Lahore — Lahore

Идентификаторы

NCT: NCT07334587 · AllamaIqbalMC1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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