Spots Global Cancer Trial Database for Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
Official Title: 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
Study ID: NCT00107172
Conditions
Study Description
Brief Summary: This randomized phase III trial studies surgery and internal radiation therapy to see how well they work compared to surgery alone in treating patients with stage I non-small cell lung cancer. Surgery may be an effective treatment for non-small cell lung cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery and internal radiation therapy are more effective than surgery alone in treating non-small cell lung cancer.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States
University of California Davis Cancer Center, Sacramento, California, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Evanston Hospital, Evanston, Illinois, United States
Cancer Institute at St. John's Hospital, Springfield, Illinois, United States
Regional Cancer Center at Memorial Medical Center, Springfield, Illinois, United States
Simmons Cooper Cancer Institute, Springfield, Illinois, United States
Cancer Institute at St. Joseph Medical Center, Towson, Maryland, United States
Boston University Cancer Research Center, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Valley Hospital - Ridgewood, Ridgewood, New Jersey, United States
South Nassau Communities Hospital, Oceanside, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
Knight Cancer Institute at Oregon Health and Science University, Portland, Oregon, United States
Jameson Memorial Hospital - North Campus, New Castle, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
UPMC Cancer Centers, Pittsburgh, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center, Reading, Pennsylvania, United States
Rhode Island Hospital Comprehensive Cancer Center, Providence, Rhode Island, United States
Miriam Hospital, Providence, Rhode Island, United States
U.T. Medical Center Cancer Institute, Knoxville, Tennessee, United States
Methodist Hospital, Houston, Texas, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray, Utah, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center, Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle, Washington, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States
London Regional Cancer Program at London Health Sciences Centre, London, Ontario, Canada
Contact Details
Name: Hiran C. Fernando, MD
Affiliation: Boston Medical Center
Role: STUDY_CHAIR
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