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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.

NCT ID: NCT00148395

Last Updated: 2008-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2008-04-30

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.

Detailed Description

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Conditions

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Non-Small-Cell Lung Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gemcitabine

Intervention Type DRUG

Navelbine

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Cisplatin

Intervention Type DRUG

Mitomycin

Intervention Type DRUG

Ifosfamide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aktion Bronchialkarzinom e.V.

OTHER

Sponsor Role lead

Principal Investigators

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Martin Wolf, MD

Role: STUDY_CHAIR

Klinikum Kassel GmbH

Locations

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Klinikum Kassel GmbH

Kassel, , Germany

Site Status

Countries

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Germany

Other Identifiers

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NSCLC 06/2001

Identifier Type: -

Identifier Source: org_study_id