Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients
OBJECTIVES:
Primary
- To determine the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT)
in medically inoperable patients with centrally located stage I non-small cell lung
cancer. (Phase I)
- To determine the efficacy of SBRT when administered at the MTD in these patients.
(Phase I)
- To estimate the local control rate of SBRT at the MTD in these patients. (Phase II)
Secondary
- To estimate the rates of adverse events (other than dose-limiting toxicity) of ≥ grade
3 that is possibly, probably, or definitely related to treatment and that occurs within
1 year after the start of SBRT in these patients.
- To estimate the rates of late adverse events (i.e., occurs > 1 year after the start of
SBRT) in these patients.
- To estimate the local control and progression-free and overall survival rates in
patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo stereotactic body radiotherapy every 2 days over 1½-2 weeks (total of 5
fractions) in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of stereotactic body radiotherapy (SBRT) as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 (Phase I)
From start of SBRT until 1 year.
Yes
Andrea Bezjak, MD, MSC, FRCPC
Principal Investigator
Princess Margaret Hospital, Canada
United States: Federal Government
RTOG-0813
NCT00750269
February 2009
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
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 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough, Maine 04074 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles, California 90048-1865 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
M.D. Anderson Cancer Center at Orlando | Orlando, Florida 32806 |
Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
Tulane Cancer Center Office of Clinical Research | Alexandria, Louisiana 71315-3198 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |
St. Luke's - Roosevelt Hospital Center - St.Luke's Division | New York, New York 10027 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Frederick R. and Betty M. Smith Cancer Treatment Center | Sparta, New Jersey 07871 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
Sentara Cancer Institute at Sentara Norfolk General Hospital | Norfolk, Virginia 23507 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Dale and Frances Hughes Cancer Center at Pocono Medical Center | East Stroudsburg, Pennsylvania 18301 |
Veterans Affairs Medical Center - Milwaukee | Milwaukee, Wisconsin 53295 |
Frankford Hospital Cancer Center - Torresdale Campus | Philadelphia, Pennsylvania 19114 |
Radiation Oncology Centers - Cameron Park | Cameron Park, California 95682 |
Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |
CCOP - Kansas City | Prairie Village, Kansas 66208 |
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center | Burbank, California 91505 |
Arizona Center for Cancer Care - Peoria | Peoria, Arizona 85381 |
McLaren Cancer Institute | Flint, Michigan 48532 |
Norton Suburban Hospital | Louisville, Kentucky 40207 |
Cooper CyberKnife Center | Mount Laurel, New Jersey 08054 |