A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas
OBJECTIVES:
Primary
- Determine the marginal-failure rate in young patients with low-grade gliomas treated
with reduced-field conformal radiotherapy.
Secondary
- Determine the progression-free survival, event-free survival, and overall survival
rates of young patients treated with this regimen.
- Determine quality of life of patients treated with this regimen.
- Correlate MIB-1 labeling index with progression-free survival and overall survival of
these patients.
OUTLINE: This is a multicenter study.
Patients undergo reduced-field conformal radiotherapy 5 days a week for 6 weeks in the
absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline or 6 weeks after completion of study treatment and
then at 2 and 5 years (closed as of 10/27/2010).
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 2 years, and then annually thereafter.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Marginal-failure rate
Patients who do not recur as well as those with either central or distant recurrence would be treatment successes for this endpoint. Monitoring will be based on a Bayesian rule, with binomial likelihood and a Beta on the parameter p, the proportion of failures that are marginal failures.
Up to 5 years
No
Joel M. Cherlow, MD
Study Chair
Todd Cancer Institute at Long Beach Memorial Medical Center
United States: Federal Government
ACNS0221
NCT00238264
November 2006
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
New York Medical College | Valhalla, New York 10595 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Children's Hospital of Orange County | Orange, California 92668 |
Children's Mercy Hospital | Kansas City, Missouri 64108 |
St. Joseph's Hospital and Medical Center | Paterson, New Jersey 07503 |
Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Nemours Children's Clinic | Jacksonville, Florida 32207 |
Miami Children's Hospital | Miami, Florida 33155-4069 |
All Children's Hospital | St. Petersburg, Florida 33701 |
Saint Jude Midwest Affiliate | Peoria, Illinois 61637 |
Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
St. Christopher's Hospital for Children | Philadelphia, Pennsylvania 19134-1095 |
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
Driscoll Children's Hospital | Corpus Christi, Texas 78466 |
Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Phoenix Children's Hospital | Phoenix, Arizona 85016-7710 |
Southern California Permanente Medical Group | Downey, California 90242 |
Children's Hospital Central California | Madera, California 93638-8762 |
Kosair Children's Hospital | Louisville, Kentucky 40202-3830 |
Palmetto Health South Carolina Cancer Center | Columbia, South Carolina 29203 |
East Tennessee Children's Hospital | Knoxville, Tennessee 37901 |
Covenant Children's Hospital | Lubbock, Texas 79410 |
Children's Hospital of the King's Daughters | Norfolk, Virginia 23507 |
Midwest Children's Cancer Center at Children's Hospital of Wisconsin | Milwaukee, Wisconsin 53226 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
Winthrop University Hospital | Mineola, New York 11501 |
Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Long Beach, California 90801 |
Kaiser Permanente Medical Center - Oakland | Sacramento, California 95825 |
Lee Cancer Care of Lee Memorial Health System | Fort Myers, Florida 33901 |
Nemours Children's Clinic - Orlando | Orlando, Florida 32806 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola, Florida 32504 |
St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa, Florida 33607 |
Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach, Florida 33407 |
St. Vincent Indianapolis Hospital | Indianapolis, Indiana 46260 |
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore, Maryland 21215 |
Breslin Cancer Center at Ingham Regional Medical Center | Lansing, Michigan 48910 |
Hackensack University Medical Center Cancer Center | Hackensack, New Jersey 07601 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Rainbow Babies and Children's Hospital | Cleveland, Ohio 44106-5000 |
Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
Rhode Island Hospital Comprehensive Cancer Center | Providence, Rhode Island 02903 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Texas Tech University Health Sciences Center School of Medicine - Amarillo | Amarillo, Texas 79106 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
Methodist Children's Hospital of South Texas | San Antonio, Texas 78229-3993 |
Primary Children's Medical Center | Salt Lake City, Utah 84113-1100 |
Providence Cancer Center at Sacred Heart Medical Center | Spokane, Washington 99220-2555 |
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington, West Virginia 25701 |
Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown, West Virginia 26506 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Memorial Cancer Institute at Memorial Regional Hospital | Hollywood, Florida 33021 |
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles, California 90048-1865 |
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
Childrens Hospital Los Angeles | Los Angeles, California 90027 |
Children's Hospital and Research Center Oakland | Oakland, California 94609 |
Rady Children's Hospital - San Diego | San Diego, California 92123-4282 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
Children's Hospital Center for Cancer and Blood Disorders | Aurora, Colorado 80045 |
Alfred I. duPont Hospital for Children | Wilmington, Delaware 19803 |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
M.D. Anderson Cancer Center at Orlando | Orlando, Florida 32806 |
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Atlanta, Georgia 30322 |
MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise, Idaho 83712-6297 |
University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
Keyser Family Cancer Center at Advocate Hope Children's Hospital | Oak Lawn, Illinois 60453 |
Advocate Lutheran General Cancer Care Center | Park Ridge, Illinois 60068-1174 |
Simmons Cooper Cancer Institute | Springfield, Illinois 62794-9677 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
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 |
Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Maimonides Cancer Center at Maimonides Medical Center | Brooklyn, New York 11219 |
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |
Akron Children's Hospital | Akron, Ohio 44308-1062 |
Nationwide Children's Hospital | Columbus, Ohio 43205-2696 |
Dayton Children's - Dayton | Dayton, Ohio 45404-1815 |
Tod Children's Hospital | Youngstown, Ohio 44501 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |
Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland, Oregon 97227 |
Penn State Children's Hospital | Hershey, Pennsylvania 17033-0850 |
Children's Hospital of Pittsburgh of UPMC | Pittsburgh, Pennsylvania 15213 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Carilion Medical Center for Children at Roanoke Community Hospital | Roanoke, Virginia 24014 |
West Virginia University Health Sciences Center - Charleston | Charleston, West Virginia 25302 |
UAB Comprehensive Cancer Center | Birmingham, Alabama 35294 |
University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |
Greenville Hospital Cancer Center | Greenville, South Carolina 29605 |
Connecticut Children's Medical Center | Hartford, Connecticut 06106 |