Status:
COMPLETED
Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy.
Lead Sponsor:
Aktion Bronchialkarzinom e.V.
Conditions:
Non-Small-Cell Lung Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- Histological verified non-small cell lung cancer. Cytological diagnosis is accepted for doubtless results.
- Present stage IIIb with malignant pleural effusion or stage IV disease. Tumor dissemination should not be irradiable in one field
- Age between 18 and 75 years
- Karnofsky index 70 - 100%
- Measurable or evaluable tumor parameter
- No prior chemotherapy for NSCLC
- Sufficient hematological parameter before start of therapy (leucocytes \> 3.500/µl and platelets \> 100.000/µl).
- Sufficient liver function (bilirubin \< 1,6mg/dl)
- Sufficient renal function (creatinine \< 1,5mg/dl and clearance \> 60ml/min)
- Minimal estimated life expectancy \> 3 months
- Written informed consent for study attendance
- Patient accessibility for therapy and follow up
- No attendance to an other study
Exclusion
- Small-cell lung cancer oder tumors with small-cell fractions
- Local advanced irradiable stage III
- Previous chemotherapy because of other diseases, not longer than 3 years ago
- Simultaneous radiation of all present tumor manifestations
- Simultaneous or not longer than 3 years ago secondary malignancy, except carcinoma in situ of the cervix or dermal cancer, others than melanoma
- Respiratory insufficiency
- Heart insufficiency NYHA III and IV
- Peripheral arteriosclerosis stage III and IV
- Neurological and psychiatric diseases, which affect understanding of the study concept and the possibility to keep conditions of the protocol
- Pregnancy, breastfeeding or not ensured contraception
- HIV-infection
- Active hepatitis B and C
- Manifest infectious diseases before start of therapy
- Minimal estimated life expectancy \< 3 months
- No written informed consent of the patient for study attendance and storage and disclosure of disease data according to the protocol
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2008
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00148395
Start Date
June 1 2002
End Date
April 1 2008
Last Update
April 22 2008
Active Locations (1)
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1
Klinikum Kassel GmbH
Kassel, Germany, 34125