Modified FOLFOXIRI Plus Target Therapy as a First Line Treatment for Advanced Colorectal Cancer a Prospective Phase Two Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Treatment-related adverse events
研究概览
简要总结
This prospective Phase II study aims to evaluate the efficacy and safety of a modified FOLFOXIRI regimen in the treatment of metastatic colorectal cancer (MCRC). FOLFOXIRI, though effective, is known for its high toxicity, necessitating close monitoring and dose adjustments. .
The primary endpoint is to assess the impact on the objective response rate and evaluate both acute and delayed toxicity. The secondary endpoints include studying the treatment's effectiveness as conversion therapy, along with disease-free survival (DFS) and overall survival (OS). The tertiary endpoint focuses on evaluating predictive and prognostic factors of significance.
This study seeks to balance the efficacy of FOLFOXIRI with a modified dose to minimize toxicity while maintaining therapeutic benefits, providing a potentially safer and effective option for patients with MCRC.
详细描述
This prospective Phase II clinical trial aims to assess the efficacy and safety of a modified dose regimen of FOLFOXIRI in the treatment of metastatic colorectal cancer (MCRC). FOLFOXIRI is a chemotherapy regimen known for its high toxicity, necessitating close monitoring, dose reductions, and supportive treatments. While previous studies have demonstrated the clinical efficacy of FOLFOXIRI compared to FOLIRI or FOLFOX, the regimen's toxicity remains a significant concern.
Intervention:
Modified FOLFOXIRI Regimen:
Oxaliplatin: 85 mg/m² IV over 2 hours (Day 1) Irinotecan: 150 mg/m² IV over 90 minutes (Day 1) 5-FU: 2400 mg/m² IV over 48 hours infusion (Day 1)
Targeted Therapy:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed unrespectable or metastatic colorectal cancer with or without primary tumor in situ.
- •Patients were required to have measurable disease according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) (Eisenhauer EA,2009)
- •ECOG PS 0-1 better to exclude PS II as this protocol is known to be toxic
- •Adequate baseline hematology and clinical chemistry labs
- •Adequate cardiac function
排除标准
- •Double Malignancy
- •DPYD mutant patients
- •Peripheral neuropathy grade 3 or higher patient due to other comorbidities
- •Inflammatory bowel syndrome or any other chronic GIT disease
- •Prior exposure to chemotherapy treatment for colorectal cancer in the metastatic setting
- •Patients who have contraindications for one or more of the study protocol drugs
研究组 & 干预措施
modified FOLFOXIRI plus target therapy
- Pre-Treatment Medications:
- Atropine SC: Administered before irinotecan infusion to prevent side effects.
- High-Risk Anti-Emetics Regimen: Used to prevent acute and delayed vomiting.
-
Chemotherapy Regimen: All eligible patients will receive the modified FOLFOXIRI regimen as follows:
-
Oxaliplatin: 85 mg/m² IV over 2 hours (Day 1)
-
Irinotecan: 150 mg/m² IV over 90 minutes (Day 1)
-
5-FU: 2400 mg/m² IV over 48 hours infusion (Days 1)
-
Targeted Therapy: Administered according to NRAS/KRAS status and the location of the primary tumor:
-
KRAS/NRAS/BRAF Wild-Type (Left-Sided Tumor): Anti-EGFR treatment with either Panitumumab (6 mg/kg over 60 minutes, Day 1) or Cetuximab (500 mg/m², Day 1).
-
KRAS/NRAS Mutant or Right-Sided Tumor: Bevacizumab at a dose of 5 mg/kg IV over 30 to 90 minutes (Day 1).
-
Treatment Schedule: The treatment will be administered biweekly for a maximum of 12 cycles (6 months).
干预措施: FOLFOXIRI Protocol (Drug)
结局指标
主要结局
Treatment-related adverse events
时间窗: 12 months
evaluate treatment-related acute and delayed toxicity
Objective Response Rate
时间窗: 6 months
To assess the impact of the treatment on the objective response rate
次要结局
- Progression free survival(12 months)
- Overall survival(24 months)
- Conversion therapy(4 months)
研究者
Mohamed Ahmed Abdelaziz
Specialist of Oncology
Al-Azhar University