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临床试验/NCT07334587
NCT07334587Enrolling By Invitation不适用

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

Allama Iqbal Medical College1 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2025年9月1日最近更新:
干预措施

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

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

Experimental

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

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.

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

发起方
Allama Iqbal Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Parnia Ansari

Principal Investigator

Allama Iqbal Medical College

研究点 (1)

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