A Randomized Phase III Study of Sublobar Resection Versus Sublobar Resection Plus Brachytherapy in High Risk Patients With Non-Small Cell Lung Cancer (NSCLC), 3cm or Smaller
- Compare time to local recurrence, in terms of recurrence within the same lobe or hilum
(N1 nodes) or progression at the staple line (after treatment effects [i.e., scarring]
have subsided), in high-risk patients with stage I non-small cell lung cancer treated
with sublobar resection with vs without intraoperative brachytherapy.
- Compare procedure-specific morbidity and mortality in patients treated with these
- Compare overall and failure-free survival of patients treated with these regimens.
- Compare freedom from regional or distant recurrence in patients treated with these
- Determine the effect of histologically or cytologically positive resection margins on
time to local recurrence in patients treated with these regimens.
- Determine the effect of brachytherapy on quality of life of these patients.
- Determine the effect of brachytherapy on pulmonary function in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
- 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 an iodine I 125 implant at the resection margin.
Quality of life is assessed at baseline and then at 3, 12, and 24 months.
After completion of study treatment, patients are followed at 3 and 6 months, every 6 months
for 2.5 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 226 patients (113 per treatment arm) will be accrued for this
study within 3 years.
Allocation: Randomized, Primary Purpose: Treatment
Time to local recurrence
Hiran C. Fernando, MD
Boston Medical Center
United States: Federal Government
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Mayo Clinic Scottsdale||Scottsdale, Arizona 85259|
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|University of Wisconsin Paul P. Carbone Comprehensive Cancer Center||Madison, Wisconsin 53792-6164|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756-0002|
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|University of California Davis Cancer Center||Sacramento, California 95817|
|Swedish Cancer Institute at Swedish Medical Center - First Hill Campus||Seattle, Washington 98104|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|
|SUNY Upstate Medical University Hospital||Syracuse, New York 13210|
|Presbyterian Cancer Center at Presbyterian Hospital||Charlotte, North Carolina 28233-3549|
|Rhode Island Hospital Comprehensive Cancer Center||Providence, Rhode Island 02903|
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|
|Simmons Cooper Cancer Institute||Springfield, Illinois 62794-9677|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|Knight Cancer Institute at Oregon Health and Science University||Portland, Oregon 97239-3098|
|University of Virginia Cancer Center||Charlottesville, Virginia 22908|
|Fox Chase Cancer Center - Philadelphia||Philadelphia, Pennsylvania 19111-2497|
|UPMC Cancer Centers||Pittsburgh, Pennsylvania 15232|
|Allegheny Cancer Center at Allegheny General Hospital||Pittsburgh, Pennsylvania 15212|
|Evanston Hospital||Evanston, Illinois 60201-1781|
|McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center||Reading, Pennsylvania 19612-6052|
|Jon and Karen Huntsman Cancer Center at Intermountain Medical Center||Murray, Utah 84157|
|Regional Cancer Center at Memorial Medical Center||Springfield, Illinois 62781-0001|
|Methodist Hospital||Houston, Texas 77030|
|Miriam Hospital||Providence, Rhode Island 02906|
|Cancer Institute at St. John's Hospital||Springfield, Illinois 62701|
|Boston University Cancer Research Center||Boston, Massachusetts 02118|
|Valley Hospital - Ridgewood||Ridgewood, New Jersey 07450|
|South Nassau Communities Hospital||Oceanside, New York 11572|
|U.T. Medical Center Cancer Institute||Knoxville, Tennessee 37920-6999|
|Jameson Memorial Hospital - North Campus||New Castle, Pennsylvania 16105|
|Cancer Institute at St. Joseph Medical Center||Towson, Maryland 21204|
|Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center||Seattle, Washington 98111|