Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	CALGB-9633 RTOG-9616, CLB-C9633, NCT00002852

Special Category: CTSU trial

Objectives

1. 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.
2. 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.
3. Determine the influence of adjuvant chemotherapy on cancer-free survival relative to marker expression in these patients.

Entry 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

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

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

Expected Enrollment

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

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.

Strauss GM, Herndon JE 2nd, Maddaus MA, et al.: 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 26 (31): 5043-51, 2008.[PUBMED Abstract]

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, et al.: Referral patterns for adjuvant chemotherapy in patients with completely resected non-small cell lung cancer. J Thorac Oncol 2 (1): 39-43, 2007.[PUBMED Abstract]

Hotta K, Matsuo K, Kiura K, et al.: Advances in our understanding of postoperative adjuvant chemotherapy in resectable non-small-cell lung cancer. Curr Opin Oncol 18 (2): 144-50, 2006.[PUBMED Abstract]

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 8 (1): 18-21, 2006.[PUBMED Abstract]

Visbal AL, Leighl NB, Feld R, et al.: Adjuvant Chemotherapy for Early-Stage Non-small Cell Lung Cancer. Chest 128 (4): 2933-43, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Gary Strauss, MD, Protocol chair		Ph: 401-444-5391 Email: gstrauss@lifespan.org

Radiation Therapy Oncology Group

David Johnstone, MD, Protocol chair		Ph: 585-275-1509 Email: david_johnstone@urmc.rochester.edu

Registry Information
Official Title		A PHASE III STUDY OF ADJUVANT CHEMOTHERAPY AFTER RESECTION FOR PATIENTS WITH T2N0 STAGE I NON-SMALL CELL CARCINOMA OF THE LUNG
Trial Start Date		1996-10-15
Registered in ClinicalTrials.gov		NCT00002852
Date Submitted to PDQ		1996-10-15
Information Last Verified		2003-12-10
NCI Grant/Contract Number		CA31946