radiation in stage i or stage ii non-small cell lung cancer that cannot be removed by surgery

Conditions: Lung Cancer

Summary: 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.

Eligibility criteria:
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

Keywords: stage i non-small cell lung cancer stage ii non-small cell lung cancer adenocarcinoma of the lung adenosquamous cell lung cancer bronchoalveolar cell lung cancer large cell lung cancer squamous cell lung cancer