Clinical trial NCT00148395: Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small-Cell Lung Carcinoma
Lead sponsor: Aktion Bronchialkarzinom e.V.
Sponsor class: OTHER
First posted: 2005-09-08
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: Event-free survival
measure: Quality of live
Other outcomes:
Locations:
city: Kassel
country: Germany
facility: Klinikum Kassel GmbH
Study officials:
affiliation: Klinikum Kassel GmbH
name: Martin Wolf, MD
role: STUDY_CHAIR
References: