GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Adverse Events Frequency
研究概览
简要总结
This is a prospective, randomized study designed to compare genotype-guided dosing to usual care in patients with pancreas cancer and colorectal cancer who are UGT1A1 intermediate metabolizers (*1/*28) (heterozygotes) and usual UGT metabolizers (*1/*1). All patients will be assessed for UGT1A1 genotype at screening and those with intermediate or usual UGT1A1 genotypes (*1/*28, *1/*1) will be randomized to genotype-guided dosing versus usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically confirmed stage I-IV pancreas or stage III-IV colorectal cancer who are planning to undergo treatment.
- •Prior treatment is allowed, specifically surgery and/or radiation and non-irinotecan containing regimens are allowed.
- •Age ≥ 18 years.
- •ECOG performance status ≤
- •Patients must have adequate organ and marrow function as defined below:
- •Measurable or non-measurable disease.
排除标准
- •Patients who received prior treatment with irinotecan are excluded.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician.
- •Pregnant women are excluded from this study.
- •Patients who are not planned for treatment of their cancer.
研究组 & 干预措施
Genocare Guided
干预措施: Irinotecan (Drug)
结局指标
主要结局
Adverse Events Frequency
时间窗: 6 months
To compare the frequency of cycle 1 grade 3-5 adverse effects in individuals with a \*1/\*28 or \*1/\*1 genotype who receive genotype-guided dosing and to those who are randomized to receive usual care.
次要结局
- Overall Survival(5 years)
研究者
Reema A. Patel
Assistant Professor
University of Kentucky