A prospective randomized study of adjuvant chemotherapy with navelbine and cisplatin in completely resected non small cell lung cancer

ISRCTN	ISRCTN95053737
DOI	https://doi.org/10.1186/ISRCTN95053737
Secondary identifying numbers	PM25994 IN 303 J1

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Jean-Yves Douillard
Scientific

Chef du département d'Oncologie Médicale
Head, Medical Oncology Branch
Centre R Gauducheau
Bd J Monod
St-Herblain Cedex
44805
France

Email	jy-douillard@nantes.fnclcc.fr

Study design	Randomized, open, multicenter
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	ANITA 01
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	29/12/2000

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	Both
Target number of participants	840
Key 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
Key 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
Date of first enrolment	06/12/1994
Date of final enrolment	29/12/2000

Chef du département d'Oncologie Médicale

St-Herblain Cedex
44805
France

Pierre Fabre Oncologie (France)
Research organisation

45 Place Abel Gance
Boulogne
92654
France

Phone	+33 (0)1 49 10 80 00
Email	marcello.riggi@pierre-fabre.com
"ROR"	https://ror.org/04hdhz511

Research organisation

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

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2006		Yes	No