Study of Combination of Cetuximab and Radiotherapy Added to the Standard Treatment for Oesophageal Adenocarcinoma (TRACC)
2018年3月7日 更新者：P.O. Witteveen
Multi-Modality Treatment of Resectable Oesophageal Adenocarcinoma Using Peri-operative Chemotherapy With Additional Pre-operative Combined Radiotherapy and Cetuximab
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
12
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Utrecht、荷兰、3584CX
- UMC Utrecht
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Pre-operative chemotherapy
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cetuximab initial dose 400 mg/m2 iv 1 week before start radiotherapy and subsequent weekly doses of 250 mg/m2 iv for the duration of the radiation treatment
其他名称：
45 Gy delivered in 25 fractions of 1.8 Gy 5d/wk
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
pathological complete remission
大体时间：1 month
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determination of tumor residual cell content in surgical specimen
|
1 month
|
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Resectability rate defined as the number of patients abke to undergo resection after neo-adjuvant treatment
大体时间：6 months
|
6 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Adverse events during neo-adjuvant treatment as defined by NIH CTCAE v3.0
大体时间：5 months
|
5 months
|
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Complications in the post-operative period (defined as 4 weeks after surgery) that can be attributed to surgical procedures
大体时间：4 weeks
|
4 weeks
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Progression free survival and overall survival
大体时间：5 years
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5 years
|
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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
大体时间：5 years
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5 years
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The number of R0 resection determined by the pathologist
大体时间：after surgery
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after surgery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2009年3月1日
初级完成 (实际的)
2015年12月1日
研究完成 (实际的)
2016年3月1日
研究注册日期
首次提交
2009年1月22日
首先提交符合 QC 标准的
2009年1月22日
首次发布 (估计)
2009年1月23日
研究记录更新
最后更新发布 (实际的)
2018年3月9日
上次提交的符合 QC 标准的更新
2018年3月7日
最后验证
2018年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.