Non-Small-Cell Lung Carcinoma
Conditions
Brief summary
This study wants to assess different intensive therapy sequences for the treatment of non-small-cell lung cancer. It claims less on the efficacy of different chemotherapy combinations, than more on the comparison of different strategies of sequential single-agent, sequential double-agent or sequential triple-agent therapy.
Interventions
Sponsors
Aktion Bronchialkarzinom e.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histological verified non-small cell lung cancer. Cytological diagnosis is accepted for doubtless results. 2. Present stage IIIb with malignant pleural effusion or stage IV disease. Tumor dissemination should not be irradiable in one field 3. Age between 18 and 75 years 4. Karnofsky index 70 - 100% 5. Measurable or evaluable tumor parameter 6. No prior chemotherapy for NSCLC 7. Sufficient hematological parameter before start of therapy (leucocytes \> 3.500/µl and platelets \> 100.000/µl). 8. Sufficient liver function (bilirubin \< 1,6mg/dl) 9. Sufficient renal function (creatinine \< 1,5mg/dl and clearance \> 60ml/min) 10. Minimal estimated life expectancy \> 3 months 11. Written informed consent for study attendance 12. Patient accessibility for therapy and follow up 13. No attendance to an other study
Exclusion criteria
1. Small-cell lung cancer oder tumors with small-cell fractions 2. Local advanced irradiable stage III 3. Previous chemotherapy because of other diseases, not longer than 3 years ago 4. Simultaneous radiation of all present tumor manifestations 5. Simultaneous or not longer than 3 years ago secondary malignancy, except carcinoma in situ of the cervix or dermal cancer, others than melanoma 6. Respiratory insufficiency 7. Heart insufficiency NYHA III and IV 8. Peripheral arteriosclerosis stage III and IV 9. Neurological and psychiatric diseases, which affect understanding of the study concept and the possibility to keep conditions of the protocol 10. Pregnancy, breastfeeding or not ensured contraception 11. HIV-infection 12. Active hepatitis B and C 13. Manifest infectious diseases before start of therapy 14. Minimal estimated life expectancy \< 3 months 15. No written informed consent of the patient for study attendance and storage and disclosure of disease data according to the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival | — |
| Quality of live | — |
Countries
Germany
Outcome results
None listed