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:
Aktion Bronchialkarzinom e.V.
Information provided by:
Aktion Bronchialkarzinom e.V.
ClinicalTrials.gov Identifier:
NCT00148395
First received: September 7, 2005
Last updated: April 21, 2008
Last verified: April 2008
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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: 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:
Drug Information available for:
Mitomycin
Ifosfamide
Cisplatin
Carboplatin
Vinorelbine
Gemcitabine
Gemcitabine hydrochloride
Vinorelbine tartrate
U.S. FDA Resources
Further study details as provided by Aktion Bronchialkarzinom e.V.:
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00148395 History of Changes |
| Other Study ID Numbers: | NSCLC 06/2001 |
| Study First Received: | September 7, 2005 |
| Last Updated: | April 21, 2008 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Mitomycins Mitomycin |
Isophosphamide mustard Gemcitabine Vinorelbine Cisplatin Ifosfamide Carboplatin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 22, 2013