Chemotherapy Induction and Chemoradiotherapy Combined With Cetuximab Respectively in Patients With Non-Metastatic Esophageal Carcinoma: A Multicentric Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Response rate
研究概览
简要总结
The aim of this study is the evaluate the feasibility and safety of chemotherapy induction treatment combined with cetuximab followed by chemoradiotherapy combined with cetuximab in the treatment of patients with non-metastatic esophageal cancer.
详细描述
Patients with a locoregional carcinoma of the esophagus or gastro-esophageal junction have a low survival prognosis following surgical resection. In studies published to date no positive effect upon overall survival could be demonstrated for preoperative chemotherapy or chemoradiotherapy. However, patients with a complete remission following preoperative therapy show prolonged survival.
This study design is based upon decreasing primary tumour and preventing oder delaying micrometastases by means of a chemo induction therapy, increasing R0 resection rates and preventing local recurrence by means of preoperative chemoradiotherapy, increasing the radiosensitivity of tumour cells through treatment combination with cetuximab, surgical resection of the locoregional primary tumour or definitive radiochemotherapy in case the primary tumour is inoperable.
The aim of this study is therefore to evaluate the feasibility and safety of a 3-staged therapy approach including an EGFR antibody in the treatment of patients with potentially resectable esophageal cancer, as well as the evaluation of objective response rates to this preoperative therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •histologically confirmed esophageal cancer (squamous cell carcinoma)
- •measurable, non-metastatic disease (uT1-4)
- •no previous cancer therapy (chemotherapy, radiotherapy or resection)
- •life expectancy > 3 months
- •age > 18 years
- •WHO Status ≤ 2
- •negative pregnancy test for women of child-bearing potential, and use of adequate contraception
- •hematological status: neutrophiles ≥ 1,5x10E9/L, thrombocytes ≥ 100x10E9/L
- •adequate renal function: serum creatinine ≤ 1,5 x ULN
- •adequate liver function: alkaline phosphatase < 2,5 x ULN, total bilirubin < 1,5 x ULN
排除标准
- •pregnant or nursing women
- •women of child-bearing potential without adequate contraception
- •concomitant anti-tumoral therapy except study mandated procedures
- •cervical esophageal cancer or diagnosis of metastases
- •participation in other clinical trials within the last 30 days
- •history of malignant disease within the last 5 years
- •peripheral neuropathy (NCI CTC ≥ grade 1)
- •concurrent active and serious non-malignant diseases: uncontrolled heart insufficiency, angina pectoris, hypertension or arrhythmias, liver disease, significant neurological or psychiatric conditions
- •active infections
研究组 & 干预措施
Treatment Arm
Chemo induction therapy followed by chemoradiotherapy and surgical resection or definitive radiotherapy
干预措施: Cisplatin (Drug)
Treatment Arm
Chemo induction therapy followed by chemoradiotherapy and surgical resection or definitive radiotherapy
干预措施: 5-FU (Drug)
Treatment Arm
Chemo induction therapy followed by chemoradiotherapy and surgical resection or definitive radiotherapy
干预措施: Taxotere (Drug)
Treatment Arm
Chemo induction therapy followed by chemoradiotherapy and surgical resection or definitive radiotherapy
干预措施: Cetuximab (Biological)
Treatment Arm
Chemo induction therapy followed by chemoradiotherapy and surgical resection or definitive radiotherapy
干预措施: Radiation during chemoradio-immunotherapy (Radiation)
结局指标
主要结局
Response rate
时间窗: Duration of study
Percentage of complete remissions and resection rate
时间窗: Duration of study
次要结局
- Occurrence of toxicities(Duration of study)
- Evaluation of Quality of Life(Duration of study)