Trial | NCT00148395  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    280
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.
Study Started
Jun 30
2002
Study Completion
Apr 30
2008
Last Update
Apr 22
2008
Estimate

Drug Gemcitabine

Drug Navelbine

Drug Carboplatin

Drug Cisplatin

Drug Mitomycin

Drug Ifosfamide

Criteria 

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
No Results Posted