ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: Institut Gustave Roussy
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002823
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: etoposide
Drug: vinblastine
Drug: vindesine
Drug: vinorelbine ditartrate
Procedure: radiation therapy
Phase III

MedlinePlus related topics:   Cancer    Lung Cancer   

ChemIDplus related topics:   Etoposide    Cisplatin    Vinorelbine    Vinorelbine tartrate    Etoposide phosphate    Vinblastine    Vinblastine sulfate    Vindesine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   A LARGE-SCALE TRIAL EVALUATING ADJUVANT CHEMOTHERAPY AFTER CURATIVE RESECTION OF NON-SMALL CELL LUNG CANCER

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   3300
Study Start Date:   February 1995

Detailed Description:

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.

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.

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

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002823

Show 123 study locations  Show 123 Study Locations

Sponsors and Collaborators
Institut Gustave Roussy

Investigators
Study Chair:     Thierry L. Le Chevalier, MD     Institut Gustave Roussy    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
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.
 
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.
 
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.
 
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.
 

Other Publications:

Study ID Numbers:   CDR0000065002, FRE-IALT, EU-96010
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002823
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I non-small cell lung cancer  
stage II non-small cell lung cancer  
stage III non-small cell lung cancer  
squamous cell lung cancer  
large cell lung cancer
adenocarcinoma of the lung
adenosquamous cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Vindesine
Vinblastine
Etoposide phosphate
Carcinoma
Adenocarcinoma of lung
Vinorelbine
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008




Links to all studies - primarily for crawlers