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Main
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Note: This record shows only 22 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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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN95053737 |
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Date of registration:
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22/03/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A prospective randomized study of adjuvant chemotherapy with navelbine and cisplatin in completely resected non small cell lung cancer
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Scientific title:
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Date of first enrolment:
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06/12/1994 |
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Target sample size:
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840 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN95053737 |
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Study type:
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Interventional |
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Study design:
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Randomized, open, multicenter (Treatment)
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Phase:
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Countries of recruitment
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Argentina
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Austria
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Brazil
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Czech Republic
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France
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Greece
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Italy
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Lebanon
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Poland
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Portugal
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Slovakia
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South Africa
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Spain
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United States of America
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Contacts
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Name:
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Jean-Yves
Douillard |
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Address:
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Chef du département d'Oncologie Médicale
Head, Medical Oncology Branch
Centre R Gauducheau
Bd J Monod
44805
St-Herblain Cedex
France |
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Telephone:
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Email:
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jy-douillard@nantes.fnclcc.fr |
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Affiliation:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Histologically proven primary non small cell lung cancer (NSCLC) (except bronchoalveolar carcinoma) stage I (T2N0 only), II, and IIIA according to the 1986 TNM classification
2. Complete resection of the primary tumor (all margins free of disease)
3. Age 18-75 years
4. World Health Organization (WHO) performance status =2
5. Adequate biological functions
Exclusion criteria: 1. Patients with a history of concurrent malignancy (except adequately treated non-melanoma skin cancer or in situ cervical cancer)
2. Previous treatment with adjuvant therapy
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non small cell lung cancer
Cancer
Non small cell lung cancer
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Intervention(s)
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Chemotherapy with navelbine and cisplatin versus best supportive care.
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Primary Outcome(s)
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Primary endpoint is overall survival, one-sided test, alpha = 0.05, beta = 0.10, delta = 10%, anticipated two-year survival rate is 30%, benefit expected is an absolute improvement of 10% in the two-year survival rate.
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Secondary Outcome(s)
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1. To determine disease-free survival
2. To evaluate toxicity related to chemotherapy
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Secondary ID(s)
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PM25994 IN 303 J1
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Source(s) of Monetary Support
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Pierre Fabre Research Institute (Institut de Recherche Pierre Fabre) (france)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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