Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy
18 Years
N/A
Both
Non Small Cell Lung Cancer
Trial Information
Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy
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
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 Exclusion Criteria:
- Brain metastasis (brain CT and/or MRI not needed, unless symptoms exist - clinically
indicated)
- RT field > 200 cm2
- Pregnancy
- A-P separation too large to be adequately treated with 60-Co (?)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Survival
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Branislav Jeremic, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
International Atomic Energy Agency
Authority:
Austria: Ethikkommission
Study ID:
E33029
NCT ID:
NCT00864331
Start Date:
February 2008
Completion Date:
Related Keywords:
- Non Small Cell Lung Cancer
- lung cancer
- nonsmall cell lung cancer
- radiation therapy
- chemotherapy
- Locally advanced and metastatic nonsmall cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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