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ISRCTN
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ISRCTN95053737
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ClinicalTrials.gov identifier
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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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Acronym
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ANITA 01
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Serial number at source
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PM25994 IN 303 J1
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Study hypothesis
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Whether adjuvant chemotherapy improves survival of patients with non-small-cell lung cancer (NSCLC) is not known. We aimed to compare the effect of adjuvant vinorelbine plus cisplatin versus observation on survival in patients with completely resected NSCLC.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Approved by the Consultative Committees for the Protection of Persons (Comités Consultatifs pour la Protection des Personnes [CCPPRB]) on 05/07/1994
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Study design
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Randomized, open, multicenter
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Countries of recruitment
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Argentina, Austria, Brazil, Czech Republic, France, Greece, Italy, Lebanon, Poland, Portugal, Slovakia, South Africa, Spain, United States of America
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Disease/condition/study domain
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Non small cell lung cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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06/12/1994
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Anticipated end date
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29/12/2000
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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840
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Interventions
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Chemotherapy with navelbine and cisplatin versus best supportive care.
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Primary outcome measure(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 measure(s)
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1. To determine disease-free survival
2. To evaluate toxicity related to chemotherapy
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Sources of funding
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Pierre Fabre Research Institute (Institut de Recherche Pierre Fabre) (france)
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Trial website
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Publications
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2006 results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16945766
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Contact name
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Prof
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
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City/town
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St-Herblain Cedex
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Zip/Postcode
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44805
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Country
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France
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Email
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jy-douillard@nantes.fnclcc.fr
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Sponsor
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Pierre Fabre Oncologie (France)
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Address
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45 Place Abel Gance
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City/town
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Boulogne
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Zip/Postcode
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92654
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Country
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France
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Tel
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+33 (0)1 49 10 80 00
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Email
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marcello.riggi@pierre-fabre.com
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Date applied
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01/03/2006
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Last edited
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31/08/2011
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Date ISRCTN assigned
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22/03/2006
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