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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.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00148395
First Posted: September 8, 2005
Last Update Posted: April 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Aktion Bronchialkarzinom e.V.
  Purpose

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.


Condition Intervention Phase
Non-Small-Cell Lung Carcinoma Drug: Gemcitabine Drug: Navelbine Drug: Carboplatin Drug: Cisplatin Drug: Mitomycin Drug: Ifosfamide Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Aktion Bronchialkarzinom e.V.:

Primary Outcome Measures:
  • Overall survival

Secondary Outcome Measures:
  • Event-free survival
  • Quality of live

Estimated Enrollment: 280
Study Start Date: June 2002
Study Completion Date: April 2008
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00148395


Locations
Germany
Klinikum Kassel GmbH
Kassel, Germany, 34125
Sponsors and Collaborators
Aktion Bronchialkarzinom e.V.
Investigators
Study Chair: Martin Wolf, MD Klinikum Kassel GmbH
  More Information

ClinicalTrials.gov Identifier: NCT00148395     History of Changes
Other Study ID Numbers: NSCLC 06/2001
First Submitted: September 7, 2005
First Posted: September 8, 2005
Last Update Posted: April 22, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Mitomycin
Vinorelbine
Carboplatin
Ifosfamide
Mitomycins
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Antibiotics, Antineoplastic
Nucleic Acid Synthesis Inhibitors