Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Locally Advanced Resectable Rectal Cancer: A Phase II Pilot Study
试验速览
- 阶段
- 2 期
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Complete pathological remission rate
研究概览
简要总结
This is a nonrandomised pilot trial to establish the role of intravenous cetuximab when added to a schedule of capecitabine plus pelvic radiation in patients who have locally advanced primary resectable rectal cancers.
详细描述
Preoperative radiotherapy and 5-FU based chemotherapy, along with the complete resection of the mesorectum is a standard treatment of locally advanced rectal cancer.Capecitabine has the potential to replace 5-FU as standard agent. Cetuximab is a monoclonal antibody directed against EGFR. Both agents are active in treatment of colorectal cancer and have demonstrated radiosensitising properties.The trial aims to assess the efficacy, safety and toxicity of the combination of cetuximab, capecitabine and radiation in patients with stage II and III rectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age 18 to 80 if judged fit for surgery
- •WHO performance status 0-1
- •Histologically proven rectal adenocarcinoma located below the peritoneum
- •T3-T4 or/and nodal involvement determined by rectal ultrasound or computed tomography (CT) or MRI
- •No distant metastases
- •Adequate haematological, cardiac, liver and renal function
- •Signed informed consent
- •Appropriate measures for contraception for men and women, if applicable
排除标准
- •Prior radio- and/or chemotherapy
- •Others synchronous cancers
- •History of other malignant disease
- •Significant heart disease
- •Known hypersensitivity to biological drugs
- •Pregnant or lactating patient
结局指标
主要结局
Complete pathological remission rate
时间窗: at pathological examm of surgical speciment
次要结局
- Rate of sphincter sparing surgical procedure Toxicity/safety(Toxicity/safety:during preoperative treatment, early and late postoperative follow up)