Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-Small Cell Lung Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

June 6, 2009

Start Date ^ICMJE

October 1996

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002852 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

Official Title ^ICMJE

A PHASE III STUDY OF ADJUVANT CHEMOTHERAPY AFTER RESECTION FOR PATIENTS WITH T2N0 STAGE I NON-SMALL CELL CARCINOMA OF THE LUNG

Brief 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.

Detailed Description

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Active Control

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

Drug: carboplatin
Drug: paclitaxel
Procedure: adjuvant therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

500

Completion Date

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Puerto Rico

Administrative Information

NCT ID ^ICMJE

NCT00002852

Responsible Party

Study ID Numbers ^ICMJE

CDR0000065095, CALGB-9633, RTOG-9616, CLB-C9633

Study Sponsor ^ICMJE

Cancer and Leukemia Group B

Collaborators ^ICMJE

National Cancer Institute (NCI)
Radiation Therapy Oncology Group

Investigators ^ICMJE

Study Chair:	Gary M. Strauss, MD	Rhode Island Hospital Comprehensive Cancer Center
Study Chair:	David W. Johnstone, MD	James P. Wilmot Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP