Non Small Cell Lung Cancer (NSCLC) Cancer Lung cancer
Conditions
Interventions
Patients will be randomised to sequential or concurrent chemotherapy and radiotherapy:
1. Sequential arm - patients receive 4 x 21 day cycle of vinorelbine and cisplatin, followed by radical radiother
Sponsors
Sponsor not defined - Record provided by CRUK and UCL CTC (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the overall survival of patients with stage III non-small cell cancer treated with chemotherapy comprising cisplatin and vinorelbine ditartrate (CV) followed by radical radiotherapy versus concurrent CV chemoradiotherapy followed by CV chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Compare the progression-free survival of patients treated with these regimens. 2. Compare the local progression-free survival (local control). 3. Compare the hematological, pulmonary, esophageal, and neurological toxicities. 4. Compare the response. 5. Compare the quality of life. 6. Compare the cost-effectiveness. | — |
Countries
United Kingdom
Outcome results
None listed