Advanced stage non small cell lung cancer Cancer Non small cell lung cancer
Conditions
Interventions
This is a single arm (non-randomised) phase II trial with 2 stages. The first stage will involve recruiting 31 patients. If there is evidence of activity then the trial will complete recruitment of a
Sponsors
Maidstone and Tunbridge Wells NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged greater than or equal to 70 on the day of first treatment 2. Histologically or cytologically confirmed NSCLC 3. Any stage not suitable for surgery or radical radiotherapy 4. Radiologically evaluable disease (by Response Evaluation Criteria In Solid Tumours [RECIST] criteria) of at least one measurable lesion on chest X-ray (CXR) or computed tomography (CT) 5. Performance status World Health Organization (WHO) of 0, 1 or 2 6. Life expectancy greater than 12 weeks 7. Adequate haematological and biochemical function
Exclusion criteria
Exclusion criteria: 1. Prior chemotherapy (previous surgery and palliative radiotherapy are allowed) 2. Uncontrolled non-cancer systemic disease 3. Significant clinical or laboratory abnormalities 4. Concomitant or previous malignancy likely to interfere with treatment outcome 5. WHO performance status of worse than 2 6. Inadequate renal function 7. Inadequate bone marrow function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate, measured by RECIST criteria once all patients have completed protocol defined therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression free survival, measured using the Kaplin Meier method 2. Overall survival, measured using the Kaplin Meier method 3. Survival in patients who received less than or equal to 2, greater than 2 but no more than 4 versus more than four 4 cycles of chemotherapy, measured using the Kaplin Meier method 4. Toxicity 5. Quality of life, measured using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ-C30 and QLQ-LC13). Scoring will be performed using the EORTC QLQ-C30 scoring manual 6. Comparison of the use of second and third line therapies | — |
Countries
United Kingdom
Outcome results
None listed