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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. - Article


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Ifosfamide

Ifex



Clinical Trial: 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 is currently recruiting patients.
Verified by Aktion Bronchialkarzinom e.V. September 2005

Sponsored by: Aktion Bronchialkarzinom e.V.
Information provided by: Aktion Bronchialkarzinom e.V.
ClinicalTrials.gov Identifier: NCT00148395

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 III

MedlinePlus related topics:  Cancer;   Lung Cancer

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Further Study Details: 
Primary Outcomes: Overall survival
Secondary Outcomes: Event-free survival; Quality of live
Expected Total Enrollment:  420

Study start: June 2002

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00148395

Martin Wolf, MD      ++49 (0)561 980 30 46    mwolf@klinikum-kassel.de
Thomas Acker, Studycoordinator      ++49 (0)6421 28 66 513    ackert@med.uni-marburg.de

Germany
      Klinikum Kassel GmbH, Kassel,  34125,  Germany; Recruiting
Martin Wolf, MD  ++49 (0)561 980 30 46    mwolf@klinikum-kassel.de 

Study chairs or principal investigators

Martin Wolf, MD,  Study Chair,  Klinikum Kassel GmbH   

More Information

Study ID Numbers:  NSCLC 06/2001
Last Updated:  September 7, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00148395
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13

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November 18, 2008



Page Updated: June 1, 2005
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