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

NCT00148395 | Completed Phase 3

• 1 other identifier: NSCLC 06/2001
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small-Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (2)

• Event-free survival

• Quality of live

Interventions

Gemcitabine DRUG

Navelbine DRUG

Carboplatin DRUG

Cisplatin DRUG

Mitomycin DRUG

Ifosfamide DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aktion Bronchialkarzinom e.V.: lead

Study Sites (1)

Klinikum Kassel GmbH

Kassel, 34125, Germany

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Vinorelbine; Carboplatin; Cisplatin; Mitomycin; Ifosfamide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Mitomycins; Indolequinones; Quinones; Azirines; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Oxazines

Study Officials

• Martin Wolf, MD

  Klinikum Kassel GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 8, 2005
• Study Start: June 1, 2002
• Study Completion: April 1, 2008
• Last Updated: April 22, 2008

Record last verified: 2008-04

Locations

DE (1)