Finding studies
Finding studies
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Lead
Radiation Therapy Oncology Group
With
OBJECTIVES: Primary * To compare the overall survival of patients with newly diagnosed, unresectable stage IIIA or IIIB non-small cell lung cancer treated with high- versus standard-dose conformal radiotherapy with concurrent and consolidation chemotherapy comprising carboplatin and paclitaxel. * To compare the overall survival of patients treated with versus without cetuximab in the setting of concurrent chemotherapy Secondary * To compare progression-free survival and local-regional tumor control in patients treated with these regimens. * To compare the toxicity of high- versus standard-dose conformal radiotherapy and concurrent chemotherapy with versus without cetuximab in these patients. * To investigate the prognostic and predictive effects of gross tumor volume on overall survival of patients treated with these regimens. * To compare the quality of life of patients treated with these regimens. * To correlate outcomes (i.e., survival, toxicity, or QOL) in these patients with biological parameters. * To analyze the predictive value of pre-treatment standardized uptake value (SUV) of positron emission tomography (PET) scan in predicting survival, distant metastasis, and local-regional control in patients treated with these regimens. * To explore biological markers to predict clinical outcome including survival, distant metastasis, local-regional control, and QOL (including toxicity) in patients treated with these regimens. * To prospectively collect and bank tissue, blood, and urine specimens for future biomarker analyses in predicting clinical outcome in patients treated with these regimens. * To investigate associations between epidermal growth factor receptor (EGFR) expression and toxicity, response, overall survival, and progression-free survival. OUTLINE: This is a multicenter study. Patients are stratified according to PET staging (yes vs no), radiotherapy technique (3-dimensional conformal radiotherapy vs intensity-modulated radiotherapy), Zubrod performance status (0 vs 1), and histology (squamous vs non-squamous). Patients are randomized to 1 of 4 treatment arms. (Arms II and IV closed to accrual effective 6/17/11) Patients may undergo tumor tissue, blood, and urine collection periodically during study for tissue banking or biomarker correlative studies. Patients may undergo quality-of-life assessment at baseline and periodically during study. After completion of study therapy, patients are followed periodically for 5 years and then annually thereafter.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
