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 |