Comparison of Efficacy and Safety Between FOLFOX-6 and CAPOX in Metastatic Colorectal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Disease progression
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20-70 years,
- •Both genders,
- •Diagnosed with metastatic colorectal carcinoma, receiving chemotherapy after surgery.
排除标准
- •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
研究组 & 干预措施
Group CAPOX
Participants will receive combination chemotherapy with capecitabine and oxaliplatin following standard dosing schedule after surgical management of metastatic colorectal carcinoma.
干预措施: Capecitabine and Oxaliplatin (Drug)
Group FOLFOX-6
Participants will receive combination chemotherapy with fluorouracil, leucovorin calcium, and oxaliplatin following standard FOLFOX-6 protocol after surgical management of metastatic colorectal carcinoma.
干预措施: Fluorouracil, Leucovorin Calcium, and Oxaliplatin (Drug)
结局指标
主要结局
Disease progression
时间窗: 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.
次要结局
- 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)
研究者
Parnia Ansari
Principal Investigator
Allama Iqbal Medical College
