A Phase 2 Study of Target-Guided Personalized Chemotherapy in Metastatic Colorectal Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Treatment options for patients with colorectal cancer (CRC) have increased in the last years. However, there are no validated prospective molecular markers in CRC to select which agents are better to treat any individual case. The conventional first-line treatment in CRC patients in clinical studies get a proportion of patients free of progression at 12 months ranging from 35-40% with a median of 9 months of free disease progression.
The aim of this study is to demonstrate that the identification of therapeutic targets in real time and their prospectively use to customize the treatment get a proportion of colorectal metastatic patients patients free of progression disease at 12 months of 50%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colorectal adenocarcinoma stage IV patients.
- •ECOG= 0-1
- •Age > 18 years.
- •Fit to receive chemotherapy treatment
- •Availability of tumor tissue or possibility of a tumor biopsy to determine therapeutic targets.
- •Adequate renal (Cr < 1,5 mg/d), liver (bilirubin≤1,5 mg/dl, AST and ALT ≤ 3.0 x the upper limit of normal) and normal bone marrow function ( absolute neutrophil count ≥ 1500/µl, hemoglobin ≥ 9.0g/dl and a platelet count of ≥ 100.000/µl)
排除标准
- •Contraindication for the administration of any of the drugs used in the study including capecitabine, irinotecan, oxaliplatin, cetuximab or bevacizumab.
- •Previous Chemotherapy treatment
研究组 & 干预措施
Chemotherapy treatment
Tailored chemotherapy by Therapeutic Targets
干预措施: Tailored Chemotherapy (Drug)
结局指标
主要结局
PFS
时间窗: 12 months
次要结局
- Complete Response Rate(12 months)
研究者
Sofia Perea, PharmD, PhD
Fundación Hospital de mADRID
Grupo Hospital de Madrid