RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: Phase I trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage I non-small cell lung cancer and lung dysfunction.

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

Further Study Details: 

OBJECTIVES:

• Determine the maximum tolerated course of accelerated 3-dimensional conformal radiotherapy in patients with stage I non-small cell lung cancer with pulmonary dysfunction.
• Determine the short-term and long-term toxicity of this regimen in these patients.
• Determine local tumor control, failure-free survival, and overall survival in patients treated with this regimen.
• Determine the effect of radiotherapy dose volume relationships and pre-treatment pulmonary function studies on the incidence of pulmonary toxicity in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks.

Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity.

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

PROJECTED ACCRUAL: Approximately 8-32 patients will be accrued for this study within 2-3 years.

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed stage I (T1-2, N0) non-small cell lung cancer (NSCLC)
• Squamous cell carcinoma
• Basaloid carcinoma
• Adenocarcinoma
• Bronchoalveolar carcinoma
• Adenosquamous carcinoma
• Large cell carcinoma
• Large cell neuroendocrine carcinoma
• Giant cell carcinoma
• Sarcomatoid carcinoma
• Non-small cell carcinoma not otherwise specified
• Tridimensionally measurable solitary parenchymal lung lesion no greater than 4 cm in diameter by chest CT scan (lung windows)
• No metastatic disease or hilar or mediastinal lymphadenopathy
• Must have mediastinoscopy* (anterior, cervical, or both) if mediastinal lymph nodes are greater than 1.0 cm in diameter by chest CT scan
• No positive lymph nodes on mediastinoscopy* NOTE: *Patients may have positron-emission tomography in lieu of mediastinoscopy provided there is no fludeoxyglucose F 18 uptake in the mediastinum and hilum
• Poor surgical risk, as defined by 1 of the following:
• High risk due to nonpulmonary reasons, such as renal failure, cardiac failure, or hepatic dysfunction and deemed by thoracic surgeon to be unsuitable for lobectomy
• Pulmonary dysfunction indicated by one or more of the following:
• FEV_1 less than 40% of predicted
• DLCO less than 50% of predicted
• Oxygen dependent
• Chronic PaCO_2 greater than 45 mm Hg
• VO_2 less than 15 mL/kg/min

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• See Disease Characteristics

Renal:

• See Disease Characteristics

Cardiovascular:

• See Disease Characteristics

Pulmonary:

• See Disease Characteristics

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No weight loss of more than 10% within the past 6 months
• No other active (less than 30% risk of relapse after completion of prior therapy) malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for NSCLC

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior chest radiotherapy

Surgery:

• See Disease Characteristics

California
      Veterans Affairs Medical Center - San Diego, San Diego,  California,  92161,  United States; Recruiting
Florida
      CCOP - Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States; Recruiting
      Memorial Cancer Institute at Memorial Regional Hospital, Hollywood,  Florida,  33021,  United States; Recruiting
Illinois
      Louis A. Weiss Memorial Hospital, Chicago,  Illinois,  60640,  United States; Recruiting
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States; Recruiting
Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States; Recruiting
Missouri
      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States; Recruiting
      Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States; Recruiting
Nebraska
      UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha,  Nebraska,  68198-7680,  United States; Recruiting
New York
      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse,  New York,  13057,  United States; Recruiting
      Veterans Affairs Medical Center - Buffalo, Buffalo,  New York,  14215,  United States; Recruiting
      Veterans Affairs Medical Center - Syracuse, Syracuse,  New York,  13210,  United States; Recruiting
North Carolina
      CCOP - Southeast Cancer Control Consortium, Goldsboro,  North Carolina,  27534-9479,  United States; Recruiting
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States; Recruiting
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7295,  United States; Recruiting
Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting

Study chairs or principal investigators

Jeffrey A. Bogart, MD,  Study Chair,  SUNY Upstate Medical University Hospital   

Study ID Numbers:  CDR0000068409; CALGB-39904; NCT00009789
Record last reviewed:  June 2004
Last Updated:  April 5, 2005
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00009789
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08