Neoadjuvant Conformal Radiotherapy and Concomitant CPT-11 and EGFR Inhibition With Cetuximab in Patients With Rectal Cancer Phase I Study
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Radiological (clinical) tumor response before surgery
研究概览
简要总结
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with irinotecan and cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with cetuximab and radiation therapy in treating patients who are undergoing surgery for stage III or stage IV rectal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the toxicity of irinotecan hydrochloride and cetuximab in patients with stage III or IV rectal cancer undergoing conformal or intensity-modulated radiotherapy.
Secondary
- Determine the rate of pathologic response and histological degree of tumor regression in patients treated with this regimen.
- Determine the complete resection rate (R0) in patients treated with this regimen.
- Determine the sphincter preservation rate in patients treated with this regimen.
- Determine the 30-day postoperative complication rate in patients treated with this regimen.
- Determine the local and distant relapse rate and site of disease failure in patients treated with this regimen.
- Estimate the predictive value of fludeoxyglucose F 18 positron emission tomography/CT scan for treatment response compared to endoscopic ultrasonography (EUS), CT scan, and MRI in patients treated with this regimen.
- Determine the late toxicity of this regimen in these patients.
- Determine the clinical (radiological) tumor response (i.e., MRI, CT scan, EUS) in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 74 Years（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
结局指标
主要结局
Radiological (clinical) tumor response before surgery
Pathologic response rate and histological degree of tumor regression as measured by Mandard TRG score
次要结局
未报告次要终点