Assessing Intratumoral Heterogeneity and Chemoradiation Response in Locally Advanced Rectal Cancer Utilizing Sequencing and PET/CT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Proportion of the randomly chosen samples that are successfully sequenced
研究概览
简要总结
This research trial studies genetic mutations in blood and tissue samples to see if they can be used to predict treatment response in patients with locally advanced rectal cancer undergoing chemoradiation. Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about genetic mutations or changes that occur in deoxyribonucleic acid (DNA) and help doctors understand how patients respond to treatment.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the tumor-specific mutation(s) detected using the CancerCode™ mutation panel as a predictor of pathologic response to chemoradiation for patients with rectal adenocarcinoma undergoing chemoradiation.
SECONDARY OBJECTIVES:
I. To assess the feasibility of utilizing biopsy specimens from locally advanced rectal adenocarcinoma to perform CancerCode™ mutation panel genetic testing.
II. To assess disease-free survival (DFS) and overall survival (OS) of patients treated on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Locally advanced rectal adenocarcinoma: T3-4NanyM0 or TanyN1-2M0
- •Radiologically measurable or clinically evaluable disease
- •Provide informed written consent
- •Willing to return to enrolling medical site for all study assessments
排除标准
- •Chemotherapy within 5 years prior to registration; (hormonal therapy is allowable if the disease free interval is >= 5 years)
- •Any prior pelvic radiation
- •Patients who are at high risk of complications from temporarily discontinuing anticoagulation for rectal cancer biopsies
结局指标
主要结局
Proportion of the randomly chosen samples that are successfully sequenced
时间窗: Up to 3 years
If \>= 90% of the specimens (at least 72 out of 80) are useable, the method will be considered feasible.
Tumor response measured using the tumor regression grading system
时间窗: Up to 3 years
Whether mutations in any gene on the CancerCode mutation panel are associated with tumor response will be assessed. In each sample, the presence or absence of mutations (0/1) for each gene on the panel will be evaluated. Each gene will be tested separately for its association with tumor response using a two-sample Mann-Whitney-Wilcoxon test with a type-I error of 0.05 for a two-sided test.
次要结局
- Tumor heterogeneity in patients with partial response to radiation(Up to 3 years)