EUCTR2009-016584-10-DE进行中（未招募）1 期
Multimodal therapy with and without cetuximab in patients with locally advanced esophageal carcinoma. An open-label phase III trial
Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung SAKK0 个研究点目标入组 300 人开始时间: 2010年4月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Histologically confirmed squamous cell carcinoma (including basaloid-squamous cell and adenosquamous carcinoma) or adenocarcinoma of the thoracic esophagus or the esophagogastric junction (from 5 cm below the entrance of the esophagus into the thorax to the gastric cardia (=esophagogastric junction), types I and II according to the Siewert staging system).
- •Resectable, locally advanced disease (the stage is determined by the combination of CT scan, EUS and PET and by a multidisciplinary team discussion)
- •Age: 18-75 years
- •Health status: WHO performance status (PS) = 1
- •Patient is considered operable (appropriate organ functions)
- •Adequate renal function: creatinine clearance > 60 mL/min, calculated according to the formula of Cockroft-Gault
- •Adequate pulmonary function: FEV1 > 1.5L or, if < 1.5L at least 75% of the reference value
- •Adequate hepatic function: bilirubin = 1.0 x ULN, AP = 2.5 x ULN, AST = 1.5 x ULN
- •Adequate hematologic values: neutrophils = 1.5 x 109/L, platelets = 100 x 109/L
- •Adequate coagulation profile: normal INR, PTT = 1.0 x ULN
- •Patient compliance and geographic proximity allow proper staging and follow-up.
- •Women are not breastfeeding, are using effective contraception if sexually active, are not pregnant and agree not to become pregnant during participation in the trial and during the 12 months thereafter.
- •Men agree not to father a child during participation in the trial and during the twelve months thereafter.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •Stage T1 Nany M0
- •Stage T2 N0 M0
- •Stage T4a due to infiltration of the tracheo-bronchial tree or organ involvement which cannot be operated on with curative intent (R0) as decided by a multidisciplinary team discussion
- •Distant metastasis (M1)
- •Cervical esophageal carcinoma and tumors involving the first 5 cm of the thoracic esophagus
- •Airway infiltration in case of tumors at or above the tracheal bifurcation
- •Peritoneal carcinomatosis in case of adenocarcinomas infiltrating the gastric cardia (i.e. esophagogastric junction carcinoma Siewert type I or II)
- •Previous malignancies within five years or concomitant malignancies, except: nonmelanomatous skin cancer or adequately treated in situ cervical cancer
- •Prior chemotherapy or prior RT to the chest
- •Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias)
- •Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent and answering the questions of the EQ-5D questionnaire and HEA forms (EQ-5D questionnaire and HEA forms applicable for Swiss centers and for patients who gave consent for the HEA only)
- •Active uncontrolled infection
- •Serious underlying medical condition (judged by the investigator) which could impair the ability of the patient to participate in the trial (e.g. uncontrolled diabetes mellitus, active autoimmune disease)
- •Preexisting peripheral neuropathy (> grade 1)
- •Concurrent treatment with other experimental drugs or other anti-cancer therapy; treatment in a clinical trial within 30 days prior to trial entry
- •Definite contraindications for the use of corticosteroids and antihistamines as premedication
- •Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs
- •Any concomitant drugs contraindicated for use with the trial drugs according to the product information of the pharmaceutical companies
研究者
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