Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-24 @ 1:18 PM
NCT ID:
NCT00148395
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00148395
Study Brief:
Protocol Section:
NCT00148395