NL-OMON56676撤回2 期
Feasibility trial on combination of platinum doublets and hypofractionated radiotherapy for locally advanced stage non-small cell lung carcinoma - HYPOLA
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 50
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. 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, with a clinical indication for concurrent chemo-irradiation.
- •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
- •a. Adequate 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.
- •b. Hepatic:
- •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 hyperbilirubinaemia that is predominantly unconjugated in the absence of evidence of haemolysis or hepatic pathology) who will be allowed in consultation with their physician.
- •c. Renal: 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.
排除标准
- •1. WHO*performance status * 2
- •2. FEV1 and DLCO < 35 % of the age- and sex*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. Participation in another clinical study with an investigational product during the last 4 weeks.
- •6. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
- •7. Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) that would prevent administration of chemotherapy.
- •8. 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
- •9. 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
- •10. 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
- •11. Any condition that, in the opinion of the investigator, would interfere with evaluation of the chemoradiotherapy or interpretation of patient safety or study results
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