Condition category
Cancer
Date applied
01/03/2006
Date assigned
22/03/2006
Last edited
31/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jean-Yves Douillard

ORCID ID

Contact details

Chef du département d'Oncologie Médicale
Head
Medical Oncology Branch
Centre R Gauducheau
Bd J Monod
St-Herblain Cedex
44805
France
jy-douillard@nantes.fnclcc.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PM25994 IN 303 J1

Study information

Scientific title

Acronym

ANITA 01

Study hypothesis

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.

Ethics approval

Approved by the Consultative Committees for the Protection of Persons (Comités Consultatifs pour la Protection des Personnes [CCPPRB]) on 05/07/1994

Study design

Randomized, open, multicenter

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Non small cell lung cancer

Intervention

Chemotherapy with navelbine and cisplatin versus best supportive care.

Intervention type

Drug

Phase

Not Specified

Drug names

Navelbine, cisplatin

Primary outcome measures

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.

Secondary outcome measures

1. To determine disease-free survival
2. To evaluate toxicity related to chemotherapy

Overall trial start date

06/12/1994

Overall trial end date

29/12/2000

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

840

Participant 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

Recruitment start date

06/12/1994

Recruitment end date

29/12/2000

Locations

Countries of recruitment

Argentina, Austria, Brazil, Czech Republic, France, Greece, Italy, Lebanon, Poland, Portugal, Slovakia, South Africa, Spain, United States of America

Trial participating centre

Chef du département d'Oncologie Médicale
St-Herblain Cedex
44805
France

Sponsor information

Organisation

Pierre Fabre Oncologie (France)

Sponsor details

45 Place Abel Gance
Boulogne
92654
France
+33 (0)1 49 10 80 00
marcello.riggi@pierre-fabre.com

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Pierre Fabre Research Institute (Institut de Recherche Pierre Fabre) (france)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16945766

Publication citations

  1. Results

    Douillard JY, Rosell R, De Lena M, Carpagnano F, Ramlau R, Gonzáles-Larriba JL, Grodzki T, Pereira JR, Le Groumellec A, Lorusso V, Clary C, Torres AJ, Dahabreh J, Souquet PJ, Astudillo J, Fournel P, Artal-Cortes A, Jassem J, Koubkova L, His P, Riggi M, Hurteloup P, Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial., Lancet Oncol., 2006, 7, 9, 719-727, doi: 10.1016/S1470-2045(06)70804-X.

Additional files

Editorial Notes