Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy.

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy.

Conditions
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Non-Small-Cell Lung Carcinoma

Intervention / Treatment
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* Drug: Gemcitabine
* Drug: Navelbine
* Drug: Carboplatin
* Drug: Cisplatin
* Drug: Mitomycin
* Drug: Ifosfamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine|nan|
|Drug: Navelbine|nan|
|Drug: Carboplatin|nan|
|Drug: Cisplatin|nan|
|Drug: Mitomycin|nan|
|Drug: Ifosfamide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival |  |  | 
| Quality of live |  |  |