EUCTR2016-003790-18-NL进行中（未招募）1 期
Feasibility trial on combination of platinum doublets and hypofractionated radiotherapy for locally-advanced stage and / or inoperable non-small cell lung carcinoma - HYPOLA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •1.Provision of signed, written and dated informed consent prior to any study specific procedures
- •2.Male or female aged 18 years or older
- •3.Cytological or histological proven NSCLC stage III or inoperable stage II (cT1-3-3N0-1), according to the 8th edition of the AJCC staging.
- •4.Patients with locoregional recurrent lung tumor following surgery or a second primary cancer are eligible, unless a pneumonectomy was performed.
- •5.Minimum required laboratory data
- •oAdequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) =1.5 x 109/L, platelets = 100 x 109/L, and hemoglobin = 5.5 mmol/L.
- •i.Serum bilirubin = 1.5 times the upper limit of normal (× ULN); alkaline phosphatase (AP), aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) = 3.0 × ULN.
- •ii.This does not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubin aemia that is predominantly unconjugated in the absence of evidence of haemolysis or hepatic pathology) who will be allowed in consultation with their physician.
- •oRenal: GFR = 60 ml/min; if below this threshold a creatinine clearance (CrCL) can be calculated based on the original weight based Cockcroft and Gault formula and should be = 45 ml/min.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.WHO performance status = 2
- •2.FEV-1 and DLCO < 35 % of the age- and gender adjusted normal value
- •3.Patients with grade 3 dyspnea or worse at baseline (according to CTCAE version 4.03)
- •4.Prior radiotherapy to the thorax.
- •5.Mean lung dose > 20.0 Gy and/or exceeding other organs-at-risk constraints.
- •6.Participation in another clinical study with an investigational product during the last 4 weeks.
- •7.Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
- •8.Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) that would prevent administration of chemotherapy.
- •9.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent
- •10.Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •11.Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
- •12.Any condition that, in the opinion of the investigator, would interfere with evaluation of the chemoradiotherapy or interpretation of patient safety or study results.
研究者
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