NL-OMON53100已完成不适用
EORTC randomized phase II study of pleurectomy/decortication preceded or followed by chemotherapy in patients with early stage malignant pleural mesothelioma. - Pleurectomy/decortication in mesothelioma
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients are aged 18 years or older, with pathologically proven malignant
- •pleural mesothelioma (MPM). All histological subtypes are accepted.
- •2. Stage cT1-3, N0-2, M0 according to UICC TNM classification. FDG-PET-CT scan
- •showing absence of M1, N3, supraclavicular and coeliac node involvement is
- •required. No clinical or radiological invasion of mediastinal structures
- •(heart, aorta, spine, esophagus, etc.) and no widespread chest wall invasion
- •(T4) are acceptable. Focal chest wall lesions are acceptable.
- •3. No prior treatment of any kind for mesothelioma is allowed, especially
- •prophylactic track irradiations after diagnostic procedures.
- •4. WHO performance status 0-1.
- •5. Fit to receive chemotherapy and undergo a P/D with optional removal of
- •hemidiaphragm and pericardium. The responsible surgeon and chest physician
- •should judge the required fitness prior to registration, taking into account
- •the results of all the relevant (i.e. pulmonary, cardiac) examinations.
- •6. No history of other malignancy within the last three years, except for
- •carcinoma in situ of the cervix or basal cell or spinocellular carcinoma of the
- •7. No pre-existing peripheral sensory or motor neuropathy > grade I according
- •to CTCAE v4.0.
- •8. No clinically significant pleural effusion that cannot be managed with
- •thoracentesis or pleurodesis (according to institutional practice). If
- •pleurodesis is considered, it should be done before randomization.
- •9. No significant cardiovascular morbidity (assessed by cardiologist)
- •precluding surgery.
- •10. Adequate organ function, evidenced by the following laboratory results
- •within two weeks (+/- 3 days) prior to randomization with a buffer range from
- •the normal values of +/- 5% for hematology and +/- 10% for biochemistry [with
- •the EXCEPTION of Glomerular Filtration Rate] are acceptable):
- •*absolute neutrophil count >1500/l;
- •*Platelet count >100,000/l;
- •*Hemoglobin >11.0g/dL or 7 mmol/L;
- •*Total bilirubin <=1.5 upper limit of normal (ULN);
- •*SGOT (AST), SGPT (ALT), and alkaline phosphatase <=2.5×ULN;
- •*Glomerular Filtration Rate (GFR)>= 50 ml/min according to Cockcroft and Gault
- •11. No current severe, uncontrolled systemic disease (e.g., clinically
- •significant cardiovascular, pulmonary, or metabolic disease, wound healing
- •disorders; ulcers; or bone fractures, known infection with HIV, active
- •hepatitis B and/or hepatitis C virus).
- •12. No major surgical procedure or significant traumatic injury within 28 days
- •prior to randomization or anticipation of the need for major surgery (other
- •than P/D) during the course of study treatment.
- •13. No history of receiving any investigational treatment within 28 days of
- •randomization.
- •14. No known hypersensitivity to pemetrexed or cisplatin or carboplatin or
- •their components.
- •15. Women of child bearing potential (WOCBP) must have a negative serum (or
- •urine) pregnancy test within 3 days prior to the start of chemotherapy/surgery.
- •Patients of childbearing/reproductive potential should use adequate birth
- •control measures, as defined by the investigator, during the study treatment
- •period and for at least three months after the last study treatment. A highly
- •effective method of birth control is defined as those which result in low
- 另有 1 项未显示
排除标准
- •Mentioned earlier (inclusion criteria).
研究者
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