RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Stereotactic body radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: Phase II trial to study the effectiveness of stereotactic body radiation therapy in treating patients who have inoperable stage I or stage II non-small cell lung cancer.

Condition	Treatment or Intervention	Phase
stage I non-small cell lung cancer stage II non-small cell lung cancer Squamous Cell Lung Cancer large cell lung cancer Adenocarcinoma of the Lung Bronchoalveolar Cell Lung Cancer	Procedure: radiation therapy  Procedure: stereotactic radiosurgery	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine whether treatment with stereotactic body radiotherapy results in acceptable local control (i.e., ≥ 80%) in patients with medically inoperable stage I or II non-small cell lung cancer.

Secondary

• Determine treatment-related toxicity in patients treated with this therapy.
• Determine disease-free survival, overall survival, and patterns of failure in patients treated with this therapy.

OUTLINE: This is a multicenter study.

Patients receive 3 fractions of stereotactic body radiotherapy over 8-14 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 6 and 12 weeks, every 3 months for 2 years, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 26 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
• The following primary cancer subtypes are eligible:
• Squamous cell carcinoma
• Adenocarcinoma
• Large cell carcinoma
• Bronchoalveolar cell carcinoma
• Non-small cell carcinoma not otherwise specified
• Stage I or II disease based on 1 of the following TNM stage criteria:
• T1, N0, M0
• T2 (≤ 5 cm), N0, M0
• T3 (≤ 5 cm), N0, M0 (chest wall primary tumors only)
• No primary tumor of any T-stage within or touching the zone of the proximal bronchial tree* NOTE: *Defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi)
• No primary T3 tumors involving the central chest wall (≤ 2 cm toward carina invasion) or structures of the mediastinum
• Any hilar or mediastinal lymph nodes > 1 cm on CT scan OR demonstrating suspicious uptake on positron-emission tomography scan must be biopsied and confirmed negative for NSCLC
• The primary tumor must be deemed technically resectable with a reasonable possibility of obtaining a gross total resection with negative margins (defined as a potentially curative resection [PCR])
• Deemed medically inoperable based on pulmonary function for surgical resection of NSCLC secondary to an underlying physiological problem, including any of the following medical conditions*:
• Baseline FEV_1< 40% of predicted
• Postoperative predicted FEV_1 < 30% of predicted
• Severely reduced diffusion capacity
• Baseline hypoxemia and/or hypercapnia
• Exercise oxygen consumption < 50% of predicted
• Severe pulmonary hypertension
• Diabetes mellitus with severe end organ damage
• Severe cerebral, cardiac, or peripheral vascular disease
• Severe chronic heart disease NOTE: *Patients who refuse a PCR due to preference, ideology, emotional or psychological issues, mental illness, or inability to give informed consent are not eligible
• No evidence of regional or distant metastases

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Cardiovascular

• See Disease Characteristics
• No active pericardial infection

Pulmonary

• See Disease Characteristics
• No active pulmonary infection

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active systemic infection
• No other concurrent illness that would preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy

• No concurrent biologic therapy
• No concurrent vaccine therapy

Chemotherapy

• No concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior lung or mediastinal radiotherapy
• No concurrent standard fractionated radiotherapy
• No concurrent intensity modulated radiotherapy
• No concurrent cobalt-60 or charged particle beams (including electrons, protons, or heavier ions)

Surgery

• See Disease Characteristics
• No concurrent surgery

Other

• No other concurrent antineoplastic therapy

Arizona
      Foundation for Cancer Research and Education, Phoenix,  Arizona,  85013,  United States; Recruiting
      Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn, Scottsdale,  Arizona,  85251,  United States; Recruiting
      Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea, Scottsdale,  Arizona,  85258-4512,  United States; Recruiting
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States; Recruiting
Louisiana
      Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans,  Louisiana,  70112-2699,  United States; Recruiting
Ohio
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States; Recruiting

Study chairs or principal investigators

Robert Dale Timmerman, MD,  Principal Investigator,  Simmons Cancer Center   

Study ID Numbers:  CDR0000371578; RTOG-0236; NCT00087438
Record last reviewed:  October 2004
Last Updated:  March 3, 2005
Record first received:  July 8, 2004
ClinicalTrials.gov Identifier:  NCT00087438
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08