Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
State/province [9] 0 0
Zottegem
Country [10] 0 0
Brazil
State/province [10] 0 0
Rio Grande do Sul
Country [11] 0 0
Brazil
State/province [11] 0 0
Rio de Janeiro
Country [12] 0 0
Brazil
State/province [12] 0 0
Rio De Janeiro
Country [13] 0 0
Brazil
State/province [13] 0 0
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
State/province [21] 0 0
Aulnay Sous Bois
Country [22] 0 0
France
State/province [22] 0 0
Aurillac
Country [23] 0 0
France
State/province [23] 0 0
Bagneux
Country [24] 0 0
France
State/province [24] 0 0
Beauvais
Country [25] 0 0
France
State/province [25] 0 0
Bobigny
Country [26] 0 0
France
State/province [26] 0 0
Bois Guillaume (Rouen)
Country [27] 0 0
France
State/province [27] 0 0
Bordeaux
Country [28] 0 0
France
State/province [28] 0 0
Caen
Country [29] 0 0
France
State/province [29] 0 0
Cannes
Country [30] 0 0
France
State/province [30] 0 0
Chartres
Country [31] 0 0
France
State/province [31] 0 0
Clamart
Country [32] 0 0
France
State/province [32] 0 0
Compiegne
Country [33] 0 0
France
State/province [33] 0 0
Creteil
Country [34] 0 0
France
State/province [34] 0 0
Dijon
Country [35] 0 0
France
State/province [35] 0 0
Etampes
Country [36] 0 0
France
State/province [36] 0 0
Grasse
Country [37] 0 0
France
State/province [37] 0 0
Lagny
Country [38] 0 0
France
State/province [38] 0 0
Le Havre
Country [39] 0 0
France
State/province [39] 0 0
Lille
Country [40] 0 0
France
State/province [40] 0 0
Lyon
Country [41] 0 0
France
State/province [41] 0 0
Marseille
Country [42] 0 0
France
State/province [42] 0 0
Mayenne
Country [43] 0 0
France
State/province [43] 0 0
Metz
Country [44] 0 0
France
State/province [44] 0 0
Meudon-La-Foret
Country [45] 0 0
France
State/province [45] 0 0
Montpellier
Country [46] 0 0
France
State/province [46] 0 0
Neuilly sur Seine
Country [47] 0 0
France
State/province [47] 0 0
Nice
Country [48] 0 0
France
State/province [48] 0 0
Paris
Country [49] 0 0
France
State/province [49] 0 0
Pau
Country [50] 0 0
France
State/province [50] 0 0
Poitiers
Country [51] 0 0
France
State/province [51] 0 0
Rennes
Country [52] 0 0
France
State/province [52] 0 0
Saint-Brieuc
Country [53] 0 0
France
State/province [53] 0 0
Sarcelles
Country [54] 0 0
France
State/province [54] 0 0
Sens
Country [55] 0 0
France
State/province [55] 0 0
Strasbourg
Country [56] 0 0
France
State/province [56] 0 0
Troyes
Country [57] 0 0
France
State/province [57] 0 0
Vandoeuvre-les-Nancy
Country [58] 0 0
France
State/province [58] 0 0
Villejuif
Country [59] 0 0
Greece
State/province [59] 0 0
Crete
Country [60] 0 0
Greece
State/province [60] 0 0
Athens
Country [61] 0 0
Greece
State/province [61] 0 0
Piraeus
Country [62] 0 0
Greece
State/province [62] 0 0
Rio Patras
Country [63] 0 0
Greece
State/province [63] 0 0
Thessaloniki
Country [64] 0 0
Israel
State/province [64] 0 0
Rehovot
Country [65] 0 0
Israel
State/province [65] 0 0
Tel-Aviv
Country [66] 0 0
Italy
State/province [66] 0 0
Milano
Country [67] 0 0
Italy
State/province [67] 0 0
Naples
Country [68] 0 0
Italy
State/province [68] 0 0
Palermo
Country [69] 0 0
Italy
State/province [69] 0 0
Rimini
Country [70] 0 0
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
Country [73] 0 0
Italy
State/province [73] 0 0
Udine
Country [74] 0 0
Italy
State/province [74] 0 0
Verona
Country [75] 0 0
Japan
State/province [75] 0 0
Osaka
Country [76] 0 0
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/study/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.
Bepler G, Olaussen KA, Vataire AL, Soria JC, Zheng Z, Dunant A, Pignon JP, Schell MJ, Fouret P, Pirker R, Filipits M, Brambilla E. ERCC1 and RRM1 in the international adjuvant lung trial by automated quantitative in situ analysis. Am J Pathol. 2011 Jan;178(1):69-78. doi: 10.1016/j.ajpath.2010.11.029. Epub 2010 Dec 23.
Arriagada R, Dunant A, Pignon JP, Bergman B, Chabowski M, Grunenwald D, Kozlowski M, Le Pechoux C, Pirker R, Pinel MI, Tarayre M, Le Chevalier T. Long-term results of the international adjuvant lung cancer trial evaluating adjuvant Cisplatin-based chemotherapy in resected lung cancer. J Clin Oncol. 2010 Jan 1;28(1):35-42. doi: 10.1200/JCO.2009.23.2272. Epub 2009 Nov 23.
Voortman J, Goto A, Mendiboure J, Sohn JJ, Schetter AJ, Saito M, Dunant A, Pham TC, Petrini I, Lee A, Khan MA, Hainaut P, Pignon JP, Brambilla E, Popper HH, Filipits M, Harris CC, Giaccone G. MicroRNA expression and clinical outcomes in patients treated with adjuvant chemotherapy after complete resection of non-small cell lung carcinoma. Cancer Res. 2010 Nov 1;70(21):8288-98. doi: 10.1158/0008-5472.CAN-10-1348. Epub 2010 Oct 26.
Filipits M, Pirker R, Dunant A, Lantuejoul S, Schmid K, Huynh A, Haddad V, Andre F, Stahel R, Pignon JP, Soria JC, Popper HH, Le Chevalier T, Brambilla E. Cell cycle regulators and outcome of adjuvant cisplatin-based chemotherapy in completely resected non-small-cell lung cancer: the International Adjuvant Lung Cancer Trial Biologic Program. J Clin Oncol. 2007 Jul 1;25(19):2735-40. doi: 10.1200/JCO.2006.08.2867.
Olaussen KA, Dunant A, Fouret P, Brambilla E, Andre F, Haddad V, Taranchon E, Filipits M, Pirker R, Popper HH, Stahel R, Sabatier L, Pignon JP, Tursz T, Le Chevalier T, Soria JC; IALT Bio Investigators. DNA repair by ERCC1 in non-small-cell lung cancer and cisplatin-based adjuvant chemotherapy. N Engl J Med. 2006 Sep 7;355(10):983-91. doi: 10.1056/NEJMoa060570.
Brambilla E, Dunant A, Filipits M, et al.: Prognostic and predictive role of alterations of the P53-bax-bcl2 pathway of apoptosis in the IALT (International Adjuvant Lung Cancer Trial). [Abstract] Lung Cancer 50 (Suppl 2): A-O-021, S10, 2005.
Arriagada R, Bergman B, Dunant A, Le Chevalier T, Pignon JP, Vansteenkiste J; International Adjuvant Lung Cancer Trial Collaborative Group. Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. N Engl J Med. 2004 Jan 22;350(4):351-60. doi: 10.1056/NEJMoa031644.
Le Chevalier T: Results of the Randomized International Adjuvant Lung Cancer Trial (IALT): cisplatin-based chemotherapy (CT) vs no CT in 1867 patients (pts) with resected non-small cell lung cancer (NSCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-6, 2, 2003.
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/study/NCT00002823