EUCTR2009-015402-19-BE进行中（未招募）不适用
Chimiothérapie d’induction suivie d’une radiochimiothérapie préopératoire à base de cisplatine, 5FU et panitumumab dans le traitement des cancers oesogastriques avancés et opérables
B Erasme0 个研究点目标入组 49 人开始时间: 2010年1月7日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 49
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
- 性别
- All
入选标准
- •Locally advanced gastric and EG junction adenocarcinoma with histological proof > T2a-N0 (including T2a-T3-T4 and N0 or N+).
- •Patient = 18 years of age.
- •Potentially resectable tumor.
- •Operable patient without major comorbidities (cardiovascular, pulmonary, neurological).
- •Adequate liver, renal and hematological functions.
- •Haematology:
- •oNeutrophil count =1.5x109/L
- •oPlatelet count =100x109/L
- •oLeucocyte count > 3,000/mm
- •o Hemoglobin > 9 g/dL
- •Hepatic Function:
- •oTotal bilirubin = 1.5 time the upper normal limit (UNL)
- •oASAT = 2.5xUNL
- •oALAT = 2.5xUNL
- •Renal Function
- •oCreatinine clearance =50 mL/min and serum creatinine =1.5xUNL
- •Metabolic Function
- •o Magnesium = lower limit of normal.
- •o Calcium = lower limit of normal.
- •Competent to comprehend, sign, and date the IEC/IRB approved written informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Evidence of distant metastases including distant lymph nodes (including supraclavicular, hepatoduodenal, retropancreatic, mesenteric and paraaortic).
- •Patients with non operable tumor.
- •Prior therapy for upper GI cancer.
- •Other histological types than adenocarcinoma.
- •History of other primary cancer, unless:
- •oCuratively resected non-melanomatous skin cancer
- •oCuratively treated cervical carcinoma in situ
- •oOther primary solid tumor curatively treated with no known active disease present and no treatment administered for = 5 years before enrollment
- •Presence of peripheral neuropathy > grade 1 according to CTCAE.
- •Presence of uncontrolled comorbidities.
- •Presence of organ allografts requiring immunosuppression.
- •Administration of any investigational drug or procedure in the setting of another trial.
- •Major surgery within 30 days before inclusion.
- •Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ? 1 year before enrollment/randomization
- •History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- •Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- •Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
- •Known allergy or hypersensitivity to any component of panitumumab and/or chemotherapy used
- •Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic hepatitis B infection
- •Subject unwilling or unable to comply with study requirements
- •Previously enrolled into this study
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