Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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. It is not yet known whether surgery is more effective with or without chemotherapy for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage I non-small cell lung cancer.

Further Study Information

OBJECTIVES:

• Determine the prevalence of 10 molecular biological markers (growth factors HER-2/neu and K-ras codon 12 mutations, cell cycle factors Ki-67 and rb, apoptosis factors p53 and bcl-2, angiogenesis factor viii, and adhesion protein CD-44 plus motility factor gelsolin) in patients with resected stage IB non-small cell lung cancer considered to be at high risk of recurrence.

• Compare the prognostic importance of specific markers on the failure-free survival of patients treated with paclitaxel and carboplatin vs no adjuvant therapy after resection.

• Determine the influence of adjuvant chemotherapy on cancer-free survival relative to marker expression in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor histology (squamous cell vs nonsquamous cell), degree of differentiation (poorly differentiated vs other), and mediastinal node sampling at surgery (yes vs no). Within 4-8 weeks after surgery, patients are randomized to 1 of 2 treatment arms.

• Arm I:Patients receive no further therapy.

• Arm II: Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks for 4 courses.

Patients are followed every 4 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 2.8 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically proven completely resected stage IB non-small cell lung cancer

• Surgically staged T2 N0 M0 disease

• Prior lobectomy or pneumonectomy with resection of associated N1 lymph nodes by thoracotomy or thoracoscopy required

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,800/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin less than 1.5 mg/dL

• SGOT less than 2 times upper limit of normal

Renal:

• Not specified

Other:

• No other prior malignancy except curatively treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or surgically treated carcinoma in situ of the breast

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent colony-stimulating factor therapy

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• See Disease Characteristics

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

Gary M. Strauss

Study Chair

David W. Johnstone

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00002852
Information obtained from ClinicalTrials.gov on December 14, 2011

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