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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group CAPOX | Experimental | Participants will receive combination chemotherapy with capecitabine and oxaliplatin following standard dosing schedule after surgical management of metastatic colorectal carcinoma. |
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| Group FOLFOX-6 | Active Comparator | Participants will receive combination chemotherapy with fluorouracil, leucovorin calcium, and oxaliplatin following standard FOLFOX-6 protocol after surgical management of metastatic colorectal carcinoma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatotoxicity | 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. | ithin 3 months after initiation of assigned chemotherapy regimen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Parnia Ansari | Allama Iqbal Medical College, Lahore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allama Iqbal Medical College, Lahore | Lahore | Punjab Province | 54000 | Pakistan |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| D017671 | Platinum Compounds |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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|
| 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. |
|
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| Diarrhea | Diarrhea will be defined as loose, watery stools persisting for more than 3 days during the follow-up period. | Within 3 months after initiation of assigned chemotherapy regimen |
| Discontinuation of chemotherapy | Permanent stopping of the assigned chemotherapy regimen due to severe adverse effects during the follow-up period. | Within 3 months after initiation of assigned chemotherapy regimen |
| All-cause mortality | Death from any cause occurring during the 3-month follow-up period after initiation of chemotherapy. | Within 3 months after initiation of assigned chemotherapy regimen |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D007287 | Inorganic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |