Metastatic Colorectal Carcinoma (mCRC)
Conditions
Keywords
Oxaliplatin, Metastatic colorectal cancer, Fluorouracil, Antineoplastic combined chemotherapy, Capecitabine
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.
Interventions
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.
DRUGFluorouracil, 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.
Sponsors
Allama Iqbal Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease progression | 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
| Measure | Time frame | Description |
|---|---|---|
| Hepatotoxicity | 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. |
| Diarrhea | 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. |
| Discontinuation of chemotherapy | 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. |
| All-cause mortality | 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. |
Countries
Pakistan
Outcome results
None listed