Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Non small cell lung cancer
Intervention
Chemotherapy with navelbine and cisplatin versus best supportive care.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Navelbine, cisplatin
Primary outcome measure
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 study start date
06/12/1994
Overall study end date
29/12/2000
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
75 Years
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2006 | Yes | No |