A Phase 1 Study for Evaluating the Safety of Lattice Extreme Ablative Dose (LEAD) Radiotherapy Followed by Standard-Dose Chemoradiation for Patients With Bulky Stage III Non-Small Cell Lung Cancer

Date de début de l'étude : 1 mars 2013

Inclusion Criteria: Patients must have histologically or cytologically documented stage III non-small cell lung cancer including squamous cell, adenocarcinoma, large cell carcinoma and poorly differentiated non-small cell lung cancer. Patients must have a minimum of 4 cm of measurable disease in any one continuous dimension as seen on diagnostic CT scan. Pulmonary function tests with forced expiratory volume in 1 second (FEV1) ≥1.45 liters/second. Patients must be 21 years of age or older. There is no maximum age restriction. Patients must have a Zubrod performance status of 0 or 1. Patients must have normal organ and marrow function as defined below: leukocyte > 3,000/:I absolute neutrophil count >1,500/:I platelets >100,000/:I bilirubin within normal institutional limits Aspartate transaminase (AST/SGOT)/Alanine transaminase (ALT/SGPT) 2.5 X institutional upper limit of normal Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal. Patients must have weight loss ≤ 10% over the past three months. Women of child-bearing potential and men will be asked to use adequate contraception. Patients must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Patients may not have had prior thoracic radiation at any time, or prior chemotherapy for the study cancer at any time. Patients may not be receiving any other investigational agents for the study cancer. Patients may not have evidence of brain metastases on baseline CT scan or MRI. Patients may not have measurable gross disease in the thorax <4 cm in any one continuous dimension. Patients may not have a cytologically positive pleural effusion. Patients may not have a prior invasive malignancy (unless disease-free for at least 3 years). Patients may not have had surgical resection of the present cancer. Women who are pregnant or breastfeeding will be excluded. Patients must not have any co-morbidity with life expectancy ≤ 6 months, or any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patients must not have severe lung disease defined by a history of severe chronic obstructive pulmonary disease (COPD) requiring 3 or more hospitalizations over the past year, or history of interstitial pneumonitis. Patients must not have any concurrent active malignancy. Patients must not have evidence of metastatic disease.