NCT00827671终止2 期
Multi-Modality Treatment of Resectable Oesophageal Adenocarcinoma Using Peri-operative Chemotherapy With Additional Pre-operative Combined Radiotherapy and Cetuximab
P.O. Witteveen1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Resectability rate defined as the number of patients abke to undergo resection after neo-adjuvant treatment
研究概览
简要总结
The purpose of this study is to determine whether the addition of the combination between cetuximab and radiotherapy to the standard chemotherapy for resectable oesophageal cancer is safe and adds efficacy.
详细描述
This study aims at developing a novel strategy to optimize the treatment of oesophageal adenocarcinoma and gastro-oesophageal junctional tumors with curative intent. Surgery in combination with peri-operative chemotherapy, using the combination epirubicin, cisplatin and 5-FU, as defined by the recent MAGIC trial, results in 13% increase in 5-yr survival. To improve the outcome of patients with this disease we hypothesize that the addition of pre-operative combined cetuximab-radiotherapy (cetux-RT) treatment could improve the outcome of this patient category through better local control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically proven resectable adenocarcinoma of the lower oesophagus and gastric-oesophageal junction
- •Tumour stage: T2-3 N0-1 M0, as assessed by endoscopic ultrasound and CT-scan of thorax and abdomen and ultrasound neck region. For the patients treated in this study the gastro-oesophageal junctional tumors will be staged as oesophageal tumors with respect to their lymphnode metastases.
- •Age >18y and written informed consent after at least 4 days of deliberation time from the moment the patient information has been given and has been explained.
- •Weight loss < 10% in 0.5 yr
- •WHO performance status 0-1
- •No prior radiotherapy or chemotherapy for the adenocarcinoma of the oesophagus
排除标准
- •Previous malignancy other than basal cell carcinoma of the skin or local resection for cervical carcinoma in situ.
- •Inadequate organ function as defined by:
- •Inadequate haematology (Hb < 5,5 mmol/L (red blood cell transfusions are allowed to increase the Hb at the discretion of the investigator) - neutrophils < 1,5 109/L -platelets <100*109/L),
- •Liver enzyme elevation (bili > 1,5*ULN - ASAT > 2,5*ULN - ALAT > 2,5*ULN) or
- •Impaired renal function (creatinine clearance by cockcroft < 60 cc/min)
- •Proteinuria >1,0gr/24hr
- •Tumour stage: M1a and/or tumour length > 8 cm and/or > 5 cm radially
- •Major surgery within 4 weeks prior to the start of study treatment
- •Bleeding disorder
- •Known allergy to one of the study drugs used
- •Use of any substance known to interfere with the chemotherapy clearance
- •Previous radiotherapy to the chest
- •Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments
- •Uncontrolled angina pectoris; cardiac failure or clinically significant arrhythmias
- •Continuous use of immunosuppressive agents
- •Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine
- •Prior exposure to anti-EGFR targeting agents.
- •Hearing loss > 25 dB under normal
- •Neurotoxicity > CTC grade 1
- •Pregnancy or breast feeding
- •Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
研究组 & 干预措施
Pre-operative chemotherapy
Other
干预措施: cetuximab (Drug)
Pre-operative chemotherapy
Other
干预措施: radiotherapy to oesophageal tumour (Radiation)
结局指标
主要结局
Resectability rate defined as the number of patients abke to undergo resection after neo-adjuvant treatment
时间窗: 6 months
pathological complete remission
时间窗: 1 month
determination of tumor residual cell content in surgical specimen
次要结局
- Progression free survival and overall survival(5 years)
- Define local (locoregional lymphnode metastasis as defined by TNM classification/ malignant peritonitis/ solid masses within the anatomic region of the esophagus) vs distant metastases as first manifestation of recurrence(5 years)
- The number of R0 resection determined by the pathologist(after surgery)
- Adverse events during neo-adjuvant treatment as defined by NIH CTCAE v3.0(5 months)
- Complications in the post-operative period (defined as 4 weeks after surgery) that can be attributed to surgical procedures(4 weeks)
研究者
P.O. Witteveen
Head of Department
UMC Utrecht
研究点 (1)
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