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Brief Title: Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma
Official Title: Phase III Intergroup Study of Radiotherapy With Concomitant and Adjuvant Temozolomide Versus Radiotherapy With Adjuvant PCV Chemotherapy in Patients With 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma
Study ID: NCT00887146
Brief Summary: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.
Detailed Description: This study will be a randomized phase III for patients with newly diagnosed co-deleted 1p/19q anaplastic glioma or high risk low grade glioma. The trial will only enroll patients with 1p/19q co-deletion. This study includes two arms as described in the "Arms" section. A dynamic allocation procedure will be used to allocate an equal number of patients to different arms (Arms A:B = 1:1). This procedure will balance the marginal distributions of the stratification factors among arms. The stratification factors that will be used are cooperative groups (EORTC vs. all North American groups), age (≤ 50 vs. \> 50), performance score (ECOG 0-1 vs. 2), and tumor grade (anaplastic glioma vs. low grade glioma). The primary goal is to determine whether patients who receive radiotherapy with concomitant temozolomide (TMZ) followed by adjuvant temozolomide (RT + TMZ --\> TMZ) (Arm B) have a marginally better progression free survival (PFS) as compared with patients who receive radiotherapy followed by PCV chemotherapy (RT --\> PCV)(Arm A). Secondary Goals: 1. Time to Progression - To determine whether patients who receive (RT + TMZ --\> TMZ) have a significantly longer time to progression (clinical or radiographic progression) as compared with patients who receive radiotherapy followed by adjuvant PCV chemotherapy (RT --\> PCV). 2. Correlation between exploratory biomarkers and survival - To determine whether there is a difference in survival based on t(1;19)(q10, p10) translocation status and MGMT promoter hypermethylation status. 3. Descriptive Comparisons of Additional Secondary Endpoints - To perform descriptive comparisons of additional secondary outcome endpoints, including overall survival, objective tumor response, prognostic factor analysis and quality of life. 4. Toxicity - To determine the toxicity of the treatment in each arm and perform descriptive comparisons. 5. Neurocognitive and Quality of Life (QOL) Effects - To determine the neurocognitive and QOL effects in patients treated on this protocol and correlate these results with outcome endpoints. 6. Banking of Biospecimens and Neuroimaging Studies - To store blood products (i.e., plasma, DNA and buffy coat), tumor tissue and MRI/CT images for future scientific investigations. After completion of study treatment, patients are followed every 12 weeks for 1 year, then every 4 months for 2 years and then every 6 months until progressive disease or until the end of study participation.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Providence Hospital, Mobile, Alabama, United States
Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States
Alaska Women's Cancer Care, Anchorage, Alaska, United States
Anchorage Oncology Centre, Anchorage, Alaska, United States
Katmai Oncology Group, Anchorage, Alaska, United States
Providence Alaska Medical Center, Anchorage, Alaska, United States
Saint Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
Arizona Oncology-Deer Valley Center, Phoenix, Arizona, United States
Arizona Oncology Services Foundation, Scottsdale, Arizona, United States
Kaiser Permanente-Anaheim, Anaheim, California, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn, California, United States
Mills-Peninsula Medical Center, Burlingame, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park, California, United States
Community Cancer Institute, Clovis, California, United States
University Oncology Associates, Clovis, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
Cedars Sinai Medical Center, Los Angeles, California, United States
Memorial Medical Center, Modesto, California, United States
Kaiser Permanente Oakland-Broadway, Oakland, California, United States
Kaiser Permanente-Ontario, Ontario, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California, United States
Sutter Roseville Medical Center, Roseville, California, United States
Sutter Medical Center Sacramento, Sacramento, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, United States
Kaiser Permanente-South San Francisco, South San Francisco, California, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville, Vacaville, California, United States
Sutter Solano Medical Center/Cancer Center, Vallejo, California, United States
The Medical Center of Aurora, Aurora, Colorado, United States
UCHealth University of Colorado Hospital, Aurora, Colorado, United States
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose, Colorado Springs, Colorado, United States
UCHealth Memorial Hospital Central, Colorado Springs, Colorado, United States
Saint Francis Cancer Center, Colorado Springs, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Saint Anthony Hospital, Lakewood, Colorado, United States
Littleton Adventist Hospital, Littleton, Colorado, United States
Longmont United Hospital, Longmont, Colorado, United States
Banner McKee Medical Center, Loveland, Colorado, United States
Parker Adventist Hospital, Parker, Colorado, United States
Saint Mary Corwin Medical Center, Pueblo, Colorado, United States
Yale University, New Haven, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull, Trumbull, Connecticut, United States
Sibley Memorial Hospital, Washington, District of Columbia, United States
Boca Raton Regional Hospital, Boca Raton, Florida, United States
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
AdventHealth Orlando, Orlando, Florida, United States
Orlando Health Cancer Institute, Orlando, Florida, United States
Emory Proton Therapy Center, Atlanta, Georgia, United States
Emory University Hospital Midtown, Atlanta, Georgia, United States
Piedmont Hospital, Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
Saint Alphonsus Cancer Care Center-Caldwell, Caldwell, Idaho, United States
Saint Alphonsus Cancer Care Center-Nampa, Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls, Post Falls, Idaho, United States
Illinois CancerCare-Bloomington, Bloomington, Illinois, United States
Illinois CancerCare-Canton, Canton, Illinois, United States
Illinois CancerCare-Carthage, Carthage, Illinois, United States
Centralia Oncology Clinic, Centralia, Illinois, United States
Northwestern University, Chicago, Illinois, United States
University of Illinois, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Illinois CancerCare-Eureka, Eureka, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center, Galesburg, Illinois, United States
Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, United States
AMITA Health Adventist Medical Center, La Grange, Illinois, United States
Illinois CancerCare-Macomb, Macomb, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Cancer Care Center of O'Fallon, O'Fallon, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Advocate Lutheran General Hospital, Park Ridge, Illinois, United States
Illinois CancerCare-Pekin, Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin, Pekin, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
OSF Saint Francis Medical Center, Peoria, Illinois, United States
Illinois CancerCare-Peru, Peru, Illinois, United States
Valley Radiation Oncology, Peru, Illinois, United States
Illinois CancerCare-Princeton, Princeton, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Parkview Hospital Randallia, Fort Wayne, Indiana, United States
Parkview Regional Medical Center, Fort Wayne, Indiana, United States
Memorial Regional Cancer Center Day Road, Mishawaka, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
McFarland Clinic - Ames, Ames, Iowa, United States
Mercy Cancer Center-West Lakes, Clive, Iowa, United States
Mission Cancer and Blood - West Des Moines, Clive, Iowa, United States
Greater Regional Medical Center, Creston, Iowa, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Mission Cancer and Blood - Des Moines, Des Moines, Iowa, United States
Broadlawns Medical Center, Des Moines, Iowa, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
Mission Cancer and Blood - Laurel, Des Moines, Iowa, United States
Iowa Lutheran Hospital, Des Moines, Iowa, United States
Methodist West Hospital, West Des Moines, Iowa, United States
Mercy Medical Center-West Lakes, West Des Moines, Iowa, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, United States
University of Kansas Hospital-Indian Creek Campus, Overland Park, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
Norton Hospital Pavilion and Medical Campus, Louisville, Kentucky, United States
Norton Brownsboro Hospital and Medical Campus, Louisville, Kentucky, United States
West Jefferson Medical Center, Marrero, Louisiana, United States
Maine Medical Center-Bramhall Campus, Portland, Maine, United States
Maine Medical Center- Scarborough Campus, Scarborough, Maine, United States
Maine Medical Partners Neurology, Scarborough, Maine, United States
Maine Medical Partners - South Portland, South Portland, Maine, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Walter Reed National Military Medical Center, Bethesda, Maryland, United States
Cancer Trials Support Unit, Rockville, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Bixby Medical Center, Adrian, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids, Michigan, United States
Trinity Health Grand Rapids Hospital, Grand Rapids, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
William Beaumont Hospital-Royal Oak, Royal Oak, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
William Beaumont Hospital - Troy, Troy, Michigan, United States
University of Michigan Health - West, Wyoming, Michigan, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Essentia Health Cancer Center, Duluth, Minnesota, United States
Miller-Dwan Hospital, Duluth, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Unity Hospital, Fridley, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center, Minneapolis, Minnesota, United States
North Memorial Medical Health Center, Robbinsdale, Minnesota, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center, Shakopee, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Rice Memorial Hospital, Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
MU Health - University Hospital/Ellis Fischel Cancer Center, Columbia, Missouri, United States
University of Kansas Cancer Center - North, Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit, Lee's Summit, Missouri, United States
University of Kansas Cancer Center at North Kansas City Hospital, North Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Saint Vincent Healthcare, Billings, Montana, United States
Benefis Sletten Cancer Institute, Great Falls, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Nebraska Cancer Specialists/Oncology Hematology West PC, Grand Island, Nebraska, United States
CHI Health Good Samaritan, Kearney, Nebraska, United States
Nebraska Hematology and Oncology, Lincoln, Nebraska, United States
Cancer Partners of Nebraska, Lincoln, Nebraska, United States
Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center, Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, United States
Nebraska Cancer Specialists - Omaha, Omaha, Nebraska, United States
Alegent Health Lakeside Hospital, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Midlands Community Hospital, Papillion, Nebraska, United States
Regional West Medical Center Cancer Center, Scottsbluff, Nebraska, United States
Radiation Oncology Centers of Nevada Central, Las Vegas, Nevada, United States
GenesisCare USA - Las Vegas, Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Southeast, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas, Nevada, United States
Renown Regional Medical Center, Reno, Nevada, United States
Saint Mary's Regional Medical Center, Reno, Nevada, United States
Radiation Oncology Associates, Reno, Nevada, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon, New Hampshire, United States
Jersey Shore Medical Center, Neptune, New Jersey, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Overlook Hospital, Summit, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
New York-Presbyterian/Brooklyn Methodist Hospital, Brooklyn, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Highland Hospital, Rochester, New York, United States
University of Rochester, Rochester, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Altru Cancer Center, Grand Forks, North Dakota, United States
Case Western Reserve University, Cleveland, Ohio, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
The Mark H Zangmeister Center, Columbus, Ohio, United States
Mount Carmel Health Center West, Columbus, Ohio, United States
Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States
ProMedica Flower Hospital, Sylvania, Ohio, United States
Saint Ann's Hospital, Westerville, Ohio, United States
Cleveland Clinic Wooster Family Health and Surgery Center, Wooster, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, United States
Clackamas Radiation Oncology Center, Clackamas, Oregon, United States
Legacy Mount Hood Medical Center, Gresham, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center, Portland, Oregon, United States
Providence Portland Medical Center, Portland, Oregon, United States
Providence Saint Vincent Medical Center, Portland, Oregon, United States
Jefferson Abington Hospital, Abington, Pennsylvania, United States
Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, United States
Saint Luke's University Hospital-Bethlehem Campus, Bethlehem, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Saint Luke's Hospital-Anderson Campus, Easton, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Temple University Hospital, Philadelphia, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Reading Hospital, West Reading, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
Prisma Health Cancer Institute - Spartanburg, Boiling Springs, South Carolina, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Greenville Health System Cancer Institute-Andrews, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Butternut, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer, Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, United States
Spartanburg Medical Center, Spartanburg, South Carolina, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
Parkland Memorial Hospital, Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
UTMB Cancer Center at Victory Lakes, League City, Texas, United States
Sandra L Maxwell Cancer Center, Cedar City, Utah, United States
Intermountain Medical Center, Murray, Utah, United States
Utah Valley Regional Medical Center, Provo, Utah, United States
Saint George Regional Medical Center, Saint George, Utah, United States
Utah Cancer Specialists-Salt Lake City, Salt Lake City, Utah, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
LDS Hospital, Salt Lake City, Utah, United States
Dartmouth Cancer Center - North, Saint Johnsbury, Vermont, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
VCU Community Memorial Health Center, South Hill, Virginia, United States
PeaceHealth Saint Joseph Medical Center, Bellingham, Washington, United States
Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States
Tri-Cities Cancer Center, Kennewick, Washington, United States
Skagit Regional Health Cancer Care Center, Mount Vernon, Washington, United States
Skagit Valley Hospital, Mount Vernon, Washington, United States
Virginia Mason Medical Center, Seattle, Washington, United States
FHCC South Lake Union, Seattle, Washington, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
University of Washington Medical Center - Montlake, Seattle, Washington, United States
PeaceHealth Southwest Medical Center, Vancouver, Washington, United States
West Virginia University Healthcare, Morgantown, West Virginia, United States
Northwest Wisconsin Cancer Center, Ashland, Wisconsin, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
ProHealth D N Greenwald Center, Mukwonago, Wisconsin, United States
ProHealth Oconomowoc Memorial Hospital, Oconomowoc, Wisconsin, United States
ProHealth Waukesha Memorial Hospital, Waukesha, Wisconsin, United States
UW Cancer Center at ProHealth Care, Waukesha, Wisconsin, United States
Medical University Vienna, Vienna, , Austria
Alegemeen Ziekenhuis Middelheim, Antwerpen, , Belgium
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BCCA-Vancouver Cancer Centre, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
London Regional Cancer Program, London, Ontario, Canada
Ottawa Hospital and Cancer Center-General Campus, Ottawa, Ontario, Canada
Odette Cancer Centre- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
CHUM - Hopital Notre-Dame, Montreal, Quebec, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Centre Leon Berard, Lyon, , France
Centre Antoine Lacassagne, Nice, , France
Gustave Roussy, Villejuif, , France
Academ Zienkenhuis Bij De University, Amsterdam, , Netherlands
University Medical Center Groningen, Groningen, , Netherlands
Maastro Clinic-Maastricht Radiation Oncology, Maastricht, , Netherlands
Erasmus University Medical Center, Rotterdam, , Netherlands
Name: Kurt Jaeckle, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR