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Combination Chemotherapy in Treating Patients With Stage I, II, or IIIA Non-small Cell Lung Cancer That Has Been Surgically Removed

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: September 19, 2013
Last verified: January 2008

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare cisplatin and etoposide with no chemotherapy in treating patients who have stage I, stage II, or stage IIIA non-small cell lung cancer that has been surgically removed.

Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: etoposide
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Adjuvant Treatment of Non Small Cell Lung Cancer

Resource links provided by NLM:

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

Estimated Enrollment: 750
Study Start Date: January 1994
Detailed Description:


  • Assess the efficacy of the combination of cisplatin and etoposide after radical surgery in prolonging the relapse free and overall survival for stages I, II, and IIIA non-small cell lung cancer.

OUTLINE: This a randomized study (treatment vs no treatment). Patients are stratified according to sex and to stage of disease (I vs II vs IIIA).

Patient receives cisplatin and etoposide on days 1-3, every 28 days, for 3 cycles. Patient may receive radiation therapy after surgery at the discretion of the physician.

PROJECTED ACCRUAL: Approximately 750 patients will be accrued over 3 years.


Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically proven stage I, II, or IIIA non-small cell lung cancer after radical surgery
  • No evidence of lymphonodal enlargement during postsurgical chest CT scan



  • 70 and under

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • WBC at least 3,500/mm3
  • Platelet count at least 100,000/mm3


  • Not specified


  • Creatinine no greater than 1.5 times the upper limit of normal


  • FEV1 at least 1 liter


  • Less than 10% weight loss in the past 3 months
  • No prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • Radical surgery required
  Contacts and Locations
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Please refer to this study by its identifier: NCT00003053

  Show 86 Study Locations
Sponsors and Collaborators
European Institute of Oncology
Study Chair: Antonio Nicolucci, MD Consorzio Mario Negri Sud
  More Information

Additional Information:
No publications provided Identifier: NCT00003053     History of Changes
Other Study ID Numbers: CDR0000065700, CNR-NICO-01, EU-97010
Study First Received: November 1, 1999
Last Updated: September 19, 2013
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 IIIA non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms processed this record on November 20, 2014