Non Small Cell Lung Cancer
Conditions
Keywords
lung cancer, nonsmall cell lung cancer, radiation therapy, chemotherapy, Locally advanced and metastatic nonsmall cell lung cancer
Brief summary
Primary objectives of the study are: To assess the differences in survival of the two treatment options in both stage III (A and B) nonsmall cell lung cancer (NSCLC) (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), respectively Secondary objectives are: To assess the differences in toxicity of two treatment options in both stage III (A and B) NSCLC (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), and To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B
Detailed description
To compare survival rates (median and 1-year), and toxicity of two treatment regimens in patients with locally advanced incurable NSCLC (study A), to compare survival rates (median and 1-year) of two treatment regimens in patients with locally advanced and metastatic NSCLC (study B) To compare HRQoL and cost effectiveness of two treatment regimens in patients with locally advanced incurable NSCLC (study A), and in patients with locally advanced and metastatic NSCLC (study B) and to evaluate the effect of HRQoL assessment on QoL dimensions
Interventions
RADIATIONradiation
39 Gy in 13 daily fractions of 3 Gy
OTHERChemotherapy and radiotherapy
Chemotherapy followed by low dose palliative radiotherapy
DRUGChemotherapy
Chemotherapy given alone
OTHERPalliative radiotherapy and chemotherapy
Low dose palliative radiotherapy followed by chemotherapy
Sponsors
International Atomic Energy Agency
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Study A Inclusion Criteria: * Histologically or cytologically confirmed NSCLC * Stage IIIA/IIIB staged with * CT chest and upper abdomen * Liver, renal, hematological reserve appropriate (according to standard institutional values) * Brain CT and/or bone scan only if clinical symptoms request such investigation * Performance status KPS 60-90 * No second cancer except skin non-melanoma * No previous treatment * Patient must be contactable for follow-up * Patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed) * Life expectancy \> 3 months * Patient must be able and willing to give informed consent, and fill in questionnaires Study A
Exclusion criteria
* Stage III B wet (existing pleural effusion , but not necessarily cytologically verified) * RT field \> 200 cm2 * Pregnancy Study B Inclusion Criteria: * KPS 60-90 * Stage IV and Stage III B (existing pleural effusions , but not necessarily cytologically verified) * Histologically or cytologically confirmed * CT staged disease (thorax and possible upper abdomen) * No second cancer except skin non-melanoma * Liver, renal, haematological reserve appropriate (according to standard institutional values) * No previous treatment * Patient must be contactable for follow-up * Patient must be able and willing to give informed consent and fill in questionnaires * Patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed) * Life expectancy \> 3 months Study B
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| To assess the differences in toxicity of two treatment options in both stage III (A and B) NSCLC (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B) | 1 year |
| To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B | 1 year |
Countries
Chile, China, Croatia, Egypt, India, Malaysia, Malta, Morocco, Pakistan, Panama, Peru, South Africa, Tunisia
Outcome results
None listed