ISRCTN91927162已完成3 期
A two-arm randomised controlled trial of concurrent chemo-radiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited stage Small Cell Lung Cancer (SCLC) and good performance status
Christie Hospital NHS Foundation Trust0 个研究点目标入组 547 人开始时间: 2007年10月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 547
研究概览
简要总结
2018 secondary results in: https://www.ncbi.nlm.nih.gov/pubmed/30520977 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28642008 2017 sub-study results in: https://www.ncbi.nlm.nih.gov/pubmed/28362511 2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/26792218
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Either sex, aged greater than or equal to 18 years
- •2. Estern Cooperative Oncology Group (ECOG) Performance Status (PS) grade 0 - 1. Patients with PS 2 whose general condition is explained by obstructive/bulky disease likely to improve after the first cycle of chemotherapy can be included at the discretion of the local investigator. Patients with PS 2 as a result of comorbid conditions will be excluded
- •3. Histologically or cytologically confirmed SCLC
- •4. No patients with mixed small-cell and non-small-cell histologic features
- •5. No history of previous malignancy in the last 5 years (except non melanomatous skin or in-situ cervix carcinoma). Patients with previous malignancies (except breast cancer) and in remission for at least 5 years can be included
- •6. Limited stage disease (Veterans Administration Lung Cancer Study Group), i.e., patients whose disease can be encompassed within a radical radiation portal
- •7. No pleural or pericardial effusions proven to be malignant
- •8. Radiotherapy (RT) target volume acceptable by the local radiotherapist
- •9. Pulmonary function:
- •9.1. Forced Expiratory Volume in one second (FEV1) greater than 1 litre or 40% predicted value
- •9.2. Carbon Monoxide Transfer Coefficient (KCO) (Carbon Monoxide Diffusing capacity in the whole Lung per unit Alveolar Volume [DLCO/VA]) greater than 40% predicted
- •10. Maximum of one of the following adverse biochemical factors:
- •10.1. Serum alkaline phosphatase more than 1.5 times the Upper Limit of Normal (ULN)
- •10.2. Serum sodium less than lower limit of normal
- •10.3. Serum lactate dehydrogenase (LDH) greater than upper limit of normal (added 09/04/2008)
- •11. Normal serum creatinine and calculated creatinine clearance greater than or equal to 50 ml/min. If calculated creatinine clearance is less than 50 ml/mn according to the Cockroft and Gault formula, an Ethylenediaminetetraacetic Acid (EDTA) clearance should be performed
- •12. Adequate haematological function:
- •12.1. Neutrophils greater than 1.5 x 10^9/l
- •12.2. Platelets greater than 100 x 10^9/l
- •13. No other previous or concomitant illness or treatment which in the opinion of the clinician will interfere with the trial treatments or comparisons
- •14. No prior surgical resection of the primary tumour, no prior radiotherapy for lung cancer
- •15. Considered fit to receive any of the trial regimens
- •16. Female patients must satisfy the investigator that they are not pregnant, or are not of child-bearing potential, or are using adequate contraception. Men must also use adequate contraception, as etoposide is clastogenic
- •17. Patients must not be breastfeeding
- •18. Patient has read the patient information sheet and has signed the consent form
- •19. Patients available for follow-up
排除标准
- •Does not comply with the above inclusion criteria.
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