A phase III randomised trial of sequential chemotherapy followed by radical radiotherapy versus concurrent chemo-radiotherapy followed by chemotherapy in patients with inoperable stage III Non-Small Cell Lung Cancer (NSCLC) and good performance status.

Sponsor not defined - Record provided by CRUK and UCL CTC (UK)0 个研究点目标入组 508 人开始时间: 2004年3月10日最近更新: 2018年11月12日

适应症

试验速览

•1. Histologically or cytologically confirmed stage III Non-Small Cell Lung Cancer (NSCLC)
•2. Performance status - Eastern Cooperative Oncology Group (ECOG) zero or one
•3. Life expectancy greater than three months
•4. Tumour judged as inoperable by thoracic surgeon or after review by MultiDisciplinary Team (MDT) including thoracic surgeon, using British Thoracic Society guidelines
•5. Age 18 or over
•6. No prior chemotherapy, radiotherapy or investigational agents
•7. Willing and able to give informed consent
•8. Willing and able to complete quality of life forms
•9. Patient considered able to tolerate platinum based chemotherapy and radical radiotherapy

•1. Stage IIIB disease with pleural effusion cytologically proven to be malignant
•2. Superior vena cava obstruction
•3. Other previous or current malignant disease likely to interfere with protocol treatment or comparisons
•4. Abnormal Liver Function Tests (LFTs) with any of: Alkaline Phosphatase, Gamma Glutamyl Transferase, Transaminases or Bilirubin more than 1.5 times Upper Limit of Normal range (ULN)
•5. Hypercalcaemia
•6. Evidence of other significant laboratory finding or concurrent uncontrolled medical illness which in the opinion of the investigator would interfere with protocol treatment or results comparison or render the subject at high risk from treatment complications
•7. Pregnancy and lactation. Effective contraception is mandatory for all patients (of reproductive potential) if sexually active
•8. Active infection

发起方

Sponsor not defined - Record provided by CRUK and UCL CTC (UK)