EUCTR2005-005139-84-ES进行中（未招募）1 期
Evaluation Of The Rate Of Pathological Complete Response (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
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 ? 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 > 2.0 x 109/lL
- •-Platelets > 100 x 109/lL
- •-Haemoglobin > 12 g/dldL
- •-Total Bilirubin bilirubin < 1.5 x ULN
- •-Transaminases < 2.5 x ULN
- •-Alkaline phosphatase < 5 x ULN
- •-Glomerular Filtration Rate < 65 mlmL/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) yes
- •F.1.2.1 Number of subjects for this age range 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
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 ? 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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