NCT07334587|Enrolling By Invitation
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Sponsor study identifier
interventional
248
1 country
1
Study Start
September 1, 2025
Actual (reported)Primary Completion
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2025
Actual (reported)December 31, 2025
Actual (reported)January 12, 2026
Actual (reported)February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Disease progression
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.
Within 3 months after initiation of assigned chemotherapy regimen
Hepatotoxicity
ithin 3 months after initiation of assigned chemotherapy regimen
Diarrhea
Within 3 months after initiation of assigned chemotherapy regimen
Discontinuation of chemotherapy
Within 3 months after initiation of assigned chemotherapy regimen
All-cause mortality
Within 3 months after initiation of assigned chemotherapy regimen
Participants will receive combination chemotherapy with capecitabine and oxaliplatin following standard dosing schedule after surgical management of metastatic colorectal carcinoma.
Participants will receive combination chemotherapy with fluorouracil, leucovorin calcium, and oxaliplatin following standard FOLFOX-6 protocol after surgical management of metastatic colorectal carcinoma.
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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Capecitabine and Oxaliplatin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Fluorouracil, Leucovorin Calcium, and Oxaliplatin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordAllama Iqbal Medical College, Lahore
Lahore, Punjab Province, 54000, Pakistan
Parnia Ansari
Allama Iqbal Medical College, Lahore
First Submitted
December 31, 2025
First Posted
January 12, 2026
Study Start
September 1, 2025
Actual (reported)Primary Completion
February 28, 2026
Estimated (date passed)Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 12, 2026
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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