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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00005868 |
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Date of registration:
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02/06/2000 |
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Primary sponsor: |
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Public title:
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Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer
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Scientific title:
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Taxotere and Cisplatin as Induction Chemotherapy in Patients With Stage IIIa N2 Non Small Cell Lung Cancer (NSCLC) |
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Date of first enrolment:
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March 2000 |
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Target sample size:
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47 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00005868 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Italy
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Netherlands
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Poland
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United Kingdom
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Contacts
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Name:
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Giuseppe Giaccone, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Free University Medical Center |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed stage IIIA non-small cell lung cancer
(NSCLC) (T1-3, N2, M0)
- Unresectable metastasis to ipsilateral mediastinal and/or subcarinal lymph nodes
- Measurable disease
- Must be at least 20 mm in one dimension by conventional techniques or at least
10 mm by spiral CT scan
- No distant metastases
- No CNS involvement
- No pleural or pericardial effusion
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than upper limit of normal (ULN)
- AST/ALT no greater than 1.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 1.25 ULN
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No superior vena cava syndrome
- No uncontrolled congestive heart failure or angina
- No myocardial infarction within past year
- No uncontrolled hypertension or arrhythmia
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No concurrent active infection requiring IV antibiotic therapy
- No other prior malignancy in past 5 years except carcinoma in situ of the cervix or
adequately treated basal cell carcinoma, excluding melanoma, breast cancer, and
hypernephroma
- No concurrent illness or medical condition which is a contraindication for
corticosteroid therapy (e.g., active ulcer, unstable diabetes mellitus)
- No motor or sensory neurotoxicity of grade 2 or greater
- No psychological, familial, sociological, or geographical condition that would
preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy
Chemotherapy:
- No prior chemotherapy for NSCLC
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy
Radiotherapy:
- No prior radiotherapy for NSCLC
- No concurrent radiotherapy
Surgery:
- No prior surgery for NSCLC
Other:
- At least 1 month since prior investigational agents
- No other concurrent experimental medications
Age minimum:
19 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lung Cancer
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Intervention(s)
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Drug: cisplatin
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Drug: docetaxel
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Secondary ID(s)
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EORTC-08984
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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