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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00002823




Registration number
NCT00002823
Ethics application status
Date submitted
1/11/1999
Date registered
11/03/2004
Date last updated
28/03/2013

Titles & IDs
Public title
Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer
Scientific title
A LARGE-SCALE TRIAL EVALUATING ADJUVANT CHEMOTHERAPY AFTER CURATIVE RESECTION OF NON-SMALL CELL LUNG CANCER
Secondary ID [1] 0 0
FRE-IALT
Secondary ID [2] 0 0
CDR0000065002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cisplatin
Treatment: Drugs - etoposide
Treatment: Drugs - vinblastine sulfate
Treatment: Drugs - vindesine
Treatment: Drugs - vinorelbine tartrate
Treatment: Other - radiation therapy

Treatment: Drugs: cisplatin


Treatment: Drugs: etoposide


Treatment: Drugs: vinblastine sulfate


Treatment: Drugs: vindesine


Treatment: Drugs: vinorelbine tartrate


Treatment: Other: radiation therapy
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS: Histologically documented non-small cell lung cancer Any non-small
cell histology eligible Pathologic stage I/II/III disease that is completely resected with
microscopically clear margins within 60 days of entry (30 days preferred)

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: Not specified Hematopoietic: Not
specified Hepatic: Not specified Renal: Not specified Other: No clear contraindication to
chemotherapy No second malignancy except: Nonmelanomatous skin cancer Carcinoma in situ of
the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic radiotherapy
Surgery: Complete resection required prior to entry
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/1995
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
South Eastern Sydney Area Health Service - Randwick
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [4] 0 0
Western Hospital - Melbourne
Recruitment hospital [5] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
8006 - East Melbourne
Recruitment postcode(s) [4] 0 0
3011 - Melbourne
Recruitment postcode(s) [5] 0 0
3181 - Melbourne
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
Argentina
State/province [3] 0 0
Buenos Aires
Country [4] 0 0
Austria
State/province [4] 0 0
Vienna
Country [5] 0 0
Belgium
State/province [5] 0 0
Brugge
Country [6] 0 0
Belgium
State/province [6] 0 0
Edegem
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Belgium
State/province [8] 0 0
Ronse
Country [9] 0 0
Belgium
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Zottegem
Country [10] 0 0
Brazil
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Rio Grande do Sul
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Brazil
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Rio de Janeiro
Country [12] 0 0
Brazil
State/province [12] 0 0
Rio De Janeiro
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Brazil
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Sao Paulo
Country [14] 0 0
Chile
State/province [14] 0 0
Santiago
Country [15] 0 0
Colombia
State/province [15] 0 0
Bogota
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Prague (Praha)
Country [17] 0 0
Egypt
State/province [17] 0 0
Cairo
Country [18] 0 0
Former Yugoslavia
State/province [18] 0 0
Belgrade
Country [19] 0 0
France
State/province [19] 0 0
Angers
Country [20] 0 0
France
State/province [20] 0 0
Armentieres
Country [21] 0 0
France
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Aulnay Sous Bois
Country [22] 0 0
France
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Aurillac
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France
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Bagneux
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France
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Beauvais
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France
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Bobigny
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France
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Bois Guillaume (Rouen)
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France
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Bordeaux
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France
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Caen
Country [29] 0 0
France
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Cannes
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France
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Chartres
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France
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Clamart
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France
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Compiegne
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France
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Creteil
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France
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Dijon
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France
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Etampes
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France
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Grasse
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France
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Lagny
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France
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Le Havre
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France
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Lille
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France
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Lyon
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France
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Marseille
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France
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Mayenne
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France
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Metz
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France
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Meudon-La-Foret
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France
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Montpellier
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France
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Neuilly sur Seine
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France
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Nice
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France
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Paris
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France
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Pau
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France
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Poitiers
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France
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Rennes
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France
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Saint-Brieuc
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France
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Sarcelles
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France
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Sens
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France
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Strasbourg
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France
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Troyes
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France
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Vandoeuvre-les-Nancy
Country [58] 0 0
France
State/province [58] 0 0
Villejuif
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Greece
State/province [59] 0 0
Crete
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Greece
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Athens
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Greece
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Piraeus
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Greece
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Rio Patras
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Greece
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Thessaloniki
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Israel
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Rehovot
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Israel
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Tel-Aviv
Country [66] 0 0
Italy
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Milano
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Italy
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Naples
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Italy
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Palermo
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Italy
State/province [69] 0 0
Rimini
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Italy
State/province [70] 0 0
Rome
Country [71] 0 0
Italy
State/province [71] 0 0
Torino
Country [72] 0 0
Italy
State/province [72] 0 0
Turin
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Italy
State/province [73] 0 0
Udine
Country [74] 0 0
Italy
State/province [74] 0 0
Verona
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Japan
State/province [75] 0 0
Osaka
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Lithuania
State/province [76] 0 0
Vilnius
Country [77] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [77] 0 0
Skopje
Country [78] 0 0
Morocco
State/province [78] 0 0
Rabat
Country [79] 0 0
Norway
State/province [79] 0 0
Tromso
Country [80] 0 0
Philippines
State/province [80] 0 0
Quezon City Diliman
Country [81] 0 0
Poland
State/province [81] 0 0
Bialystok
Country [82] 0 0
Poland
State/province [82] 0 0
Lodz
Country [83] 0 0
Poland
State/province [83] 0 0
Wroclaw
Country [84] 0 0
Poland
State/province [84] 0 0
Zdunowo
Country [85] 0 0
Portugal
State/province [85] 0 0
Lisbon (Lisboa)
Country [86] 0 0
Slovenia
State/province [86] 0 0
Ljubljana
Country [87] 0 0
South Africa
State/province [87] 0 0
Cape Town
Country [88] 0 0
South Africa
State/province [88] 0 0
Johannesburg
Country [89] 0 0
Spain
State/province [89] 0 0
Barcelona
Country [90] 0 0
Spain
State/province [90] 0 0
Granada
Country [91] 0 0
Spain
State/province [91] 0 0
Valencia
Country [92] 0 0
Sweden
State/province [92] 0 0
Gothenburg (Goteborg)
Country [93] 0 0
Sweden
State/province [93] 0 0
Linkoping
Country [94] 0 0
Sweden
State/province [94] 0 0
Lund
Country [95] 0 0
Sweden
State/province [95] 0 0
Stockholm
Country [96] 0 0
Sweden
State/province [96] 0 0
Uppsala
Country [97] 0 0
Switzerland
State/province [97] 0 0
Basel
Country [98] 0 0
Switzerland
State/province [98] 0 0
Bellinzona
Country [99] 0 0
Switzerland
State/province [99] 0 0
Chur
Country [100] 0 0
Switzerland
State/province [100] 0 0
Geneva
Country [101] 0 0
Switzerland
State/province [101] 0 0
Luzern (Lucerne)
Country [102] 0 0
Switzerland
State/province [102] 0 0
Zurich
Country [103] 0 0
Tunisia
State/province [103] 0 0
Monastir

Funding & Sponsors
Primary sponsor type
Other
Name
Gustave Roussy, Cancer Campus, Grand Paris
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. It is not yet known if combination chemotherapy given after surgery
is more effective than surgery alone for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy
following surgery with that of surgery alone in treating patients who have stage I, stage II,
or stage IIIA non-small cell lung cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00002823
Trial related presentations / publications
Reiman T, Lai R, Veillard AS, Paris E, Soria JC, Rosell R, Taron M, Graziano S, Kratzke R, Seymour L, Shepherd FA, Pignon JP, Seve P. Cross-validation study of class III beta-tubulin as a predictive marker for benefit from adjuvant chemotherapy in resected non-small-cell lung cancer: analysis of four randomized trials. Ann Oncol. 2012 Jan;23(1):86-93. doi: 10.1093/annonc/mdr033. Epub 2011 Apr 6.
Hotta K, Matsuo K, Kiura K, Ueoka H, Tanimoto M. Advances in our understanding of postoperative adjuvant chemotherapy in resectable non-small-cell lung cancer. Curr Opin Oncol. 2006 Mar;18(2):144-50. doi: 10.1097/01.cco.0000208787.91947.a2.
Pignon JP, Tribodet H, Scagliotti GV, et al.: Lung Adjuvant Cisplatin Evaluation (LACE): a pooled analysis of five randomized clinical trials including 4,584 patients. [Abstract] J Clin Oncol 24 (Suppl 18): A-7008, 2006.
Wakelee HA, Schiller JH, Gandara DR. Current status of adjuvant chemotherapy for stage IB non-small-cell lung cancer: implications for the New Intergroup Trial. Clin Lung Cancer. 2006 Jul;8(1):18-21. doi: 10.3816/CLC.2006.n.028.
Public notes

Contacts
Principal investigator
Name 0 0
Thierry L. Le Chevalier, MD
Address 0 0
Gustave Roussy, Cancer Campus, Grand Paris
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00002823