Finding studies
Finding studies
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Lead
Alliance for Clinical Trials in Oncology
With
PRIMARY OBJECTIVES: I. To ascertain whether patients treated by sublobar resection (SR) + brachytherhapy (BX) have longer time to local recurrence as compared to the patients treated by SR (local recurrence includes recurrence within the same lobe or hilum \[N1 nodes\], or progression at the staple line after treatment effects such as scarring have subsided). SECONDARY OBJECTIVES: I. To compare procedure specific morbidity and mortality between study arms. II. To compare overall survival and failure-free survival between study arms. III. To assess freedom from regional or distant recurrence. IV. To assess the effect of histological or cytologic positive resection margins on time to local recurrence. V. To determine the effect of brachytherapy on quality of life (QoL). VI. To determine the effect of brachytherapy on pulmonary function. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy. ARM II: Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising iodine I 125 implant at the resection margin. After completion of study treatment, patients are followed at 3, 6, 12, 18, 24, 30, and 36 months and then yearly for 2 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
