Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborators:	National Cancer Institute (NCI) Radiation Therapy Oncology Group
Information provided by:	Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00002852

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: paclitaxel Procedure: surgical resection	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A PHASE III STUDY OF ADJUVANT CHEMOTHERAPY AFTER RESECTION FOR PATIENTS WITH T2N0 STAGE I NON-SMALL CELL CARCINOMA OF THE LUNG

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:

Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Failure free survival [ Time Frame: q 4 mon for 2 yrs, then q 6 mon until relapse or death ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: q 4 mon for 1 yr after tx ] [ Designated as safety issue: Yes ]
Arm 2 only

Enrollment:	345
Study Start Date:	October 1996
Study Completion Date:	June 2010
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Surgical resection Surgery followed by observation	Procedure: surgical resection Resection of T2N0 stage 1 NSC Lung Cancer
Active Comparator: Adjuvant chemotherapy Surgery followed by chemotherapy	Drug: carboplatin 6 mg/ml/min over 1-2 hours following taxol infusion on days 1, 22, 43, and 64 Drug: paclitaxel 200 mg/square meter as a 3 hour infusion on days 1,22,43, and 64 Procedure: surgical resection Resection of T2N0 stage 1 NSC 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002852

Show 297 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Radiation Therapy Oncology Group

Investigators

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

More Information

Additional Information:

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

Publications:

Graziano SL, Gu L, Wang X, Tatum AH, Vollmer RT, Strauss GM, Kratzke R, Dudek AZ, Vokes EE, Green MR; Cancer and Leukemia Group B; North Central Cancer Treatment Group; Radiation Therapy Oncology Group. Prognostic significance of mucin and p53 expression in stage IB non-small cell lung cancer: a laboratory companion study to CALGB 9633. J Thorac Oncol. 2010 Jun;5(6):810-7.

Strauss GM, Herndon JE 2nd, Maddaus MA, Johnstone DW, Johnson EA, Harpole DH, Gillenwater HH, Watson DM, Sugarbaker DJ, Schilsky RL, Vokes EE, Green MR. Adjuvant Paclitaxel Plus Carboplatin Compared With Observation in Stage IB Non-Small-Cell Lung Cancer: CALGB 9633 With the Cancer and Leukemia Group B, Radiation Therapy Oncology Group, and North Central Cancer Treatment Group Study Groups. J Clin Oncol. 2008 Sep 22; [Epub ahead of print]

Strauss GM, Herndon JE, Maddaus MA, et al.: Adjuvant chemotherapy in stage IB non-small cell lung cancer (NSCLC): update of Cancer and Leukemia Group B (CALGB) protocol 9633. [Abstract] J Clin Oncol 24 (Suppl 18): A-7007, 2006.

Strauss GM, Herndon J, Maddaus MA, et al.: Randomized clinical trial of adjuvant chemotherapy with paclitaxel and carboplatin following resection in stage IB non-small cell lung cancer (NSCLC): report of Cancer and Leukemia Group B (CALGB) protocol 9633. [Abstract] J Clin Oncol 22 (Suppl 14): A-7019, 621s, 2004.

Close JL, Daniels L, Allegra CJ, et al.: Impact of 2006 ASCO Annual Meeting data release of Cancer and Leukemia Group B (CALGB) protocol 9633 on practice patterns in the United States. [Abstract] J Clin Oncol 26 (Suppl 15): A-7547, 2008.

Kassam F, Shepherd FA, Johnston M, Visbal A, Feld R, Darling G, Keshavjee S, Pierre A, Waddell T, Leighl NB. Referral patterns for adjuvant chemotherapy in patients with completely resected non-small cell lung cancer. J Thorac Oncol. 2007 Jan;2(1):39-43.

Hotta K, Matsuo K, Kiura K, Ueoka H, Tanimoto M. Advances in our understanding of postoperative adjuvant chemotherapy in resectable non-small-cell lung cancer. Curr Opin Oncol. 2006 Mar;18(2):144-50. Review.

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. 2006 Jul;8(1):18-21. Review.

Visbal AL, Leighl NB, Feld R, Shepherd FA. Adjuvant Chemotherapy for Early-Stage Non-small Cell Lung Cancer. Chest. 2005 Oct;128(4):2933-43. Review.

Responsible Party:	Monica M Bertagnolli, MD, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00002852 History of Changes
Other Study ID Numbers:	CDR0000065095, U10CA031946, CALGB-9633, RTOG-9616, CLB-C9633
Study First Received:	November 1, 1999
Last Updated:	April 1, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cancer and Leukemia Group B:

stage I non-small cell lung cancer

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 09, 2012