Lung cancer remains the most frequent cause of cancer death in both men and women in the world. Surgical resection using lobectomy with mediastinal lymph node dissection or sampling has been a standard of care for operable early stage NSCLC. Several studies have reported high local control and survival using SBRT in stage I NSCLC patients. SBRT is now an accepted treatment for medically inoperable patients with stage I NSCLC and patients with operable stage I lung cancer are entered on clinical protocols. The purpose of this study is to conduct a phase III randomized study to compare CyberKnife SBRT with surgery, the current standard of care for stage I operable NSCLC.
Objectives: Primary Goal: To compare overall survival at 3 years. Secondary goals: 1. To compare disease specific survival at 3 years. 2. To compare 3 year progression free survival at the treated primary tumor site 3. To compare grade 3 and above acute and/or chronic toxicities. 4. To evaluate predictive value of pre and post treatment PET scan in clinical outcome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy
Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings
Community Regional Medical Center
Fresno, California, United States
Penrose Cancer Center
Colorado Springs, Colorado, United States
Denver CyberKnife
Lone Tree, Colorado, United States
Jupiter Medical Center
Jupiter, Florida, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Parkview Cancer Center
Fort Wayne, Indiana, United States
Central Baptist Hospital
Lexington, Kentucky, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States
St. Mary's of Michigan
Saginaw, Michigan, United States
St. Mary's Duluth Clinic Health System
Duluth, Minnesota, United States
...and 9 more locations
Overall Survival
The study power was calculated for sample size of 420 patients, enrolled over 7 years. The actual enrollment was 36 patients over 4 years. The study was therefore terminated due to lack of enrollment. The sample size does not allow to analysis of the primary outcome. While the study data is not mature enough to evaluate the endpoints of the study, we will attempt to describe the results gleaned from the existing patient population.
Time frame: 3 years
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