EUCTR2005-005139-84-FI进行中（未招募）1 期
Evaluation of the rate of pathological complete response rate (pCR) for neoadjuvant chemoradiotherapy (CT-RT) and for chemotherapy (CT) alone in locally advanced non small cell lung cancer (LA-NSCLC): a randomised phase II trial
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
- 200
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
- •- Patients aged between 18 and 75 years
- •- Histologically or cytologically (fine needle aspiration) proven non-small cell lung cancer (NSCLC)
- •- Untreated locally advanced inoperable stage IIIA (only pN2 confirmed by mediastinoscopy)
- •- Patients with a Karnofsky Performance Status ³ 80%
- •- Adequate pulmonary function
- •- Life expectancy > 12 weeks
- •- Patients without weight loss > 10% within the previous 3 months
- •- Adequate bone marrow, hepatic and renal functions (Neutrophils ³ 2.0 x 109/L-Platelets ³ 100 x 109/L, Haemoglobin ³ 12 g/dL, Total bilirubin £ 1.5 x ULN, Transaminases £ 2.5 x ULN, Alkaline phosphatase < 5 x ULN, Glomerular Filtration Rate ³ 65 mL/min per 1.73 m2·
- •- Presence of at least one measurable lesion (RECIST)
- •- Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol
- •- Absence of current or recent (within 2 weeks before registration) severe infection
- •- Absence of renal or hearing impairment
- •- Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment
- •- Fertile men must be using an effective method of birth control if their partners are women of childbearing potential
- •- Patients who give written (personally signed and dated) inform consent before completing any study-related procedure.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients with NSCLC stages I, II, bulky IIIA (except pN2 confirmed by mediastinoscopy), IIIB and IV
- •- With tumour extent or location precluding radical radiotherapy as specified in the protocol
- •-Symptomatic neuropathy (sensory) > grade 1 according to the NCI Common Toxicity Criteria
- •- Hearing impairment ³ Grade 2
- •- Concomitant/uncontrolled medical disorder (cardiac failure or myocardial infarction within the previous 3 months; uncontrolled hypertension or arrhythmia; uncontrolled hypercalcaemia; active infection requiring I.V. antibiotics within 2 weeks before the beginning of treatment)
- •- Weight loss > 10% within the previous 3 months
- •- Pre-existing malignant pleural effusion
- •- Ascites or pericardial effusion
- •- Active secondary malignancy except appropriately treated carcinoma in situ of the cervix or skin basal cell cancer. Patients with a history of cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible.
- •- Previous or concomitant treatment with other anticancer drugs during the last 5 years
- •- Known hypersensitivity to the study drugs or to drugs with similar chemical structures
- •- Concomitant treatment with systemic corticosteroids except chronic treatment lasting more than 1 month at low doses (£ 20 mg/day of methyl prednisolone or equivalent)
- •- Significant malabsorption syndrome or disease affecting the gastrointestinal tract function and the absorption of oral drugs
- •- Women if pregnant or breast-feeding or with Positive pregnancy test at inclusion
- •- Male or female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and at least 3 months following the last dose of study treatment
- •- Participation to another clinical trial with any investigational drug study (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to registration.
研究者
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