Radiation in Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

A Phase II Study of Accelerated Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT) For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)

RATIONALE: 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: This phase II trial is studying how well radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that cannot be removed by surgery.

OBJECTIVES:

Primary

• Determine the local tumor control rate at 2 years after accelerated hypofractionated 3-dimensional, conformal radiotherapy in patients with inoperable T1-3 N0 M0 non-small cell lung cancer.

Secondary

• Determine the toxicities of this regimen in these patients.
• Determine the rates of regional and distant disease recurrence in these patients.
• Determine the progression-free and overall survival of patients treated with this regimen.
• Determine the changes in pulmonary function after treatment in these patients.
• Assess the quality of life of patients after treatment.

OUTLINE: This is a multicenter, prospective study.

Patients undergo accelerated hypofractionated conformal radiotherapy 5 days a week for up to 3 weeks (15 doses) in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at week 3 of radiotherapy, at 1 month after completion of radiotherapy, and then every 4 months for 1 year.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

  • Stage I or II peripheral disease

    • T1, N0, M0
    • T2 (≤ 5 cm), N0, M0
    • T3 (≤ 5 cm, chest wall primary tumor only), N0, M0
    • No T2-T3 primary tumors > 5 cm or any T1-T3 tumor of the mainstem bronchus involvement
    • No T1-T3 tumor in the lung apex (i.e., tumor in a position that will result in irradiation of the brachial plexus to the prescribed dose)
    • Hilar or mediastinal lymph nodes ≤ 1 cm considered N0

  • Any of the following primary cancer types:

    • Squamous cell carcinoma
    • Adenocarcinoma
    • Large cell carcinoma
    • Bronchioloalveolar cell carcinoma
    • Non-small cell carcinoma not otherwise specified

• Underlying physiological medical condition that prohibits surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functional lung (i.e., medically inoperable)

• Cytologic specimens obtained by brushing, washing, or needle aspiration of defined lesion allowed

  • If sputum cytology alone is used for diagnosis, it must be confirmed on a second specimen

• Must develop a radiotherapy plan that meets the dose-volume constraints for critical organs

• No ataxia telangiectasia

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Not pregnant or nursing

• Able and willing to complete a quality of life questionnaire unless not literate in either English or French (i.e., a translator is required to comprehend the questions and reply)

• No active systemic, pulmonary, or pericardial infection

• No previous malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix.

  • Previous diagnosis of cancer that is free of recurrence and metastases for ≥ 2 years and, in the opinion of the treating physician, does not have a substantial risk of recurrence allowed (including prior lung cancer)

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy to the area of the primary tumor
• No prior or concurrent chemotherapy or immunotherapy for this tumor