NCT00960427撤回1 期
Colorectal Cancer Stem Cells Marker Expression in Rectal Cancer Patients Undergoing Chemoradiotherapy-A Pilot Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Estimation of stem cell markers with stated precision
研究概览
简要总结
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.
PURPOSE: This phase I trial is studying biomarkers in tumor tissue and blood samples from patients undergoing chemotherapy and radiation therapy for stage II or stage III rectal cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To obtain the distribution of stem cell markers (CD166, CD44, and ESA) in tumor tissue samples before and after neoadjuvant chemoradiotherapy (NCRT) in patients with stage II or III rectal cancer.
Secondary
- To correlate disease-free survival after NCRT with baseline expression and change in expression of stem cell markers (CD166, CD44, and ESA) after NCRT.
- To correlate baseline and post-NCRT expression of all three stem cell markers (CD166, CD44, and ESA) with circulating tumor cell (CTC) count and stem cell marker expression on CTC at baseline and after NCRT.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the rectum
- •Inferior margin within 16 cm of the anal verge on endoscopic exams
- •Locally advanced or low lying disease meeting 1 of the following stage criteria:
- •Stage II (T2, N0, M0) disease
- •Distal tumor (< 5 cm from anal verge) invades into muscularis propria but not beyond (T2)
- •Stage II (T3-4, N0, M0) disease
- •Tumor invades through muscularis propria into subserosa or into non-peritonealized pericolic or perirectal tissues (T3) OR tumor directly invades other organs or structures and/or perforates visceral peritoneum (T4)
- •Stage III (any T, N1-2, M0) disease
- •Tumor has invaded to any depth with involvement of regional lymph nodes (N1-2)
- •Resectable disease
- •No suspicious metastatic disease (M1)
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Adequate organ function
- •No significant co-morbidities that would preclude the use of neoadjuvant chemoradiotherapy, including any of the following:
- •Severe heart failure
- •Arrhythmia
- •Significant liver or kidney dysfunction
- •No psychiatric or addictive disorder that would preclude study compliance
- •No bleeding diathesis
- •No contraindication for sigmoidoscopy
- •PRIOR CONCURRENT THERAPY:
- •No prior radiotherapy or chemotherapy for rectal cancer
- •No concurrent warfarin unless appropriate bridging therapy is arranged during biopsy procedures
排除标准
- 未提供
结局指标
主要结局
Estimation of stem cell markers with stated precision
Correlation of disease-free survival with post-treatment value and change in expression of colorectal cancer stem cell markers after neoadjuvant chemoradiotherapy
次要结局
未报告次要终点
研究者
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