A Biologic Study of Global Gene Expression, NF-Kappa B and p53 in Adenocarcinoma of the Rectum.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Activation of NF-kappa B in response to treatment with external beam radiotherapy
研究概览
简要总结
RATIONALE: Studying samples of tumor tissue 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 understand how patients respond to treatment.
PURPOSE: This clinical trial is studying biomarkers in patients with rectal cancer undergoing chemotherapy and radiation therapy.
详细描述
OBJECTIVES:
Primary
- Observe whether NF-kappa B is activated in response to treatment with external beam radiotherapy.
- Correlate NF-kappa B pathway activation (presumed to be anti-apoptotic in nature) with therapeutic outcomes (as measured by rate of pathologic complete response or downstaging by endoscopic ultrasound [EUS]).
Secondary
- Study downstream events induced by NF-kappa B activation.
- Determine global gene expression profiles at baseline and during chemoradiotherapy.
- Correlate changes in gene expression (compared with the baseline gene expression pattern) induced by a single dose of external beam radiotherapy with patient outcomes (as measured by pathologic response rate or downstaging by EUS).
- Study downstream events related to activation of p53 in response to treatment with radiotherapy.
- Correlate p53 pathway-mediated events with clinical outcomes.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Single Arm Trial
干预措施: capecitabine (Drug)
1
Single Arm Trial
干预措施: 5-fluorouracil (Drug)
1
Single Arm Trial
干预措施: Surgical Resection (Procedure)
1
Single Arm Trial
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Activation of NF-kappa B in response to treatment with external beam radiotherapy
时间窗: 6-8 weeks after chemoradiation
Correlation of NF-kappa B pathway activation with therapeutic outcomes
时间窗: 6-8 weeks after chemoradiation
次要结局
- Downstream events induced by NF-kappa B activation(12 months)
- Global gene expression profiles at baseline and during chemoradiotherapy(prior to chemoradiation and 72 days post chemoradiation)
- Correlation of changes in gene expression with patient outcomes(72 days post chemoradiation)
- Downstream events related to activation of p53 in response to treatment with radiotherapy(72 post radiotherapy)
- Correlation of p53 pathway-mediated events with clinical outcomes(72 days post chemoradiation)