Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer

Basic Trial Information

Objectives

I.  Compare the impact on overall survival of adjuvant cisplatin and either a 
vinca alkaloid or etoposide (with or without radiotherapy) vs. no adjuvant 
chemotherapy in patients with completely resected stage I/II/III non-small 
cell lung cancer.

II.  Assess the frequency of treatment-related deaths and severe toxic effects.

III.  Describe the patterns of failure, second malignancies, and toxic effects 
associated with each treatment regimen. 

Entry 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)

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

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

Expected Enrollment

A maximum of 3,300 patients will be accrued for this study.

Outline

This is a randomized, multicenter study.  Patients are stratified by 
participating institution, type of prior surgery, and pathologic stage.  Each 
participating center will determine which combination chemotherapy regimen and 
which of three cisplatin doses will be given to all patients treated at that 
center.

The treatment group receives cisplatin combined with either vindesine, 
vinblastine, vinorelbine, or etoposide every 3-4 weeks for 3-4 courses, 
depending on the dose of cisplatin.

The second group receives no adjuvant chemotherapy.

Treating institutions determine prior to entering the trial which patients 
receive adjuvant radiotherapy:  none; those with node-positive disease; those 
with N1 disease only; those with N2 disease only; or those eligible for a 
randomized radiotherapy trial.  For patients in the treatment group, 
radiotherapy begins 3-4 weeks after the last course.

Patients are followed at 6 months, then annually.

Bepler G, Olaussen KA, Vataire AL, et al.: ERCC1 and RRM1 in the international adjuvant lung trial by automated quantitative in situ analysis. Am J Pathol 178 (1): 69-78, 2011.[PUBMED Abstract]

Arriagada R, Dunant A, Pignon JP, et al.: Long-term results of the international adjuvant lung cancer trial evaluating adjuvant Cisplatin-based chemotherapy in resected lung cancer. J Clin Oncol 28 (1): 35-42, 2010.[PUBMED Abstract]

Voortman J, Goto A, Mendiboure J, et al.: MicroRNA expression and clinical outcomes in patients treated with adjuvant chemotherapy after complete resection of non-small cell lung carcinoma. Cancer Res 70 (21): 8288-98, 2010.[PUBMED Abstract]

Filipits M, Pirker R, Dunant A, et al.: 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 25 (19): 2735-40, 2007.[PUBMED Abstract]

Olaussen KA, Dunant A, Fouret P, et al.: DNA repair by ERCC1 in non-small-cell lung cancer and cisplatin-based adjuvant chemotherapy. N Engl J Med 355 (10): 983-91, 2006.[PUBMED Abstract]

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, et al.: Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. N Engl J Med 350 (4): 351-60, 2004.[PUBMED Abstract]

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.

Reiman T, Lai R, Veillard AS, et al.: 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 23 (1): 86-93, 2012.[PUBMED Abstract]

Hotta K, Matsuo K, Kiura K, et al.: Advances in our understanding of postoperative adjuvant chemotherapy in resectable non-small-cell lung cancer. Curr Opin Oncol 18 (2): 144-50, 2006.[PUBMED Abstract]

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 8 (1): 18-21, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Institut Gustave Roussy

Thierry Le Chevalier, MD, Protocol chair		Ph: 33-14-211-4324 Email: tle-che@igr.fr

Registry Information
Official Title		A LARGE-SCALE TRIAL EVALUATING ADJUVANT CHEMOTHERAPY AFTER CURATIVE RESECTION OF NON-SMALL CELL LUNG CANCER
Trial Start Date		1995-02-22
Registered in ClinicalTrials.gov		NCT00002823
Date Submitted to PDQ		1995-02-22
Information Last Verified		2011-04-25

Back to Top