Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

305

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
Brain and Central Nervous System Tumors
Interventions
DRUG

concomitant temozolomide (TMZ)

75 mg/m\^2, orally daily

RADIATION

radiotherapy

DRUG

procarbazine

Days 8-21: 60 mg/m\^2 orally

DRUG

adjuvant temozolomide (TMZ)

150 or 200 mg/m\^2 orally

DRUG

CCNU

Day 1: 110 mg/m\^2 orally

DRUG

vincristine

Days 8 and 29: 1.4 mg/m\^2 IV

Trial Locations (291)

2020

Alegemeen Ziekenhuis Middelheim, Antwerp

10032

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

11215

New York-Presbyterian/Brooklyn Methodist Hospital, Brooklyn

13210

State University of New York Upstate Medical University, Syracuse

14620

Highland Hospital, Rochester

14642

University of Rochester, Rochester

15212

Allegheny General Hospital, Pittsburgh

15232

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh

17822

Geisinger Medical Center, Danville

18015

Saint Luke's University Hospital-Bethlehem Campus, Bethlehem

18045

Saint Luke's Hospital-Anderson Campus, Easton

18103

Lehigh Valley Hospital-Cedar Crest, Allentown

18711

Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre

19001

Jefferson Abington Hospital, Abington

19107

Thomas Jefferson University Hospital, Philadelphia

19140

Temple University Hospital, Philadelphia

19611

Reading Hospital, West Reading

20016

Sibley Memorial Hospital, Washington D.C.

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

23298

Virginia Commonwealth University/Massey Cancer Center, Richmond

23970

VCU Community Memorial Health Center, South Hill

26506

West Virginia University Healthcare, Morgantown

27157

Wake Forest University Health Sciences, Winston-Salem

29303

Spartanburg Medical Center, Spartanburg

29316

Prisma Health Cancer Institute - Spartanburg, Boiling Springs

29425

Medical University of South Carolina, Charleston

29601

Greenville Health System Cancer Institute-Andrews, Greenville

29605

Prisma Health Cancer Institute - Butternut, Greenville

Prisma Health Cancer Institute - Faris, Greenville

29615

Prisma Health Cancer Institute - Eastside, Greenville

29650

Prisma Health Cancer Institute - Greer, Greer

29672

Prisma Health Cancer Institute - Seneca, Seneca

30308

Emory Proton Therapy Center, Atlanta

Emory University Hospital Midtown, Atlanta

30309

Piedmont Hospital, Atlanta

30322

Emory University Hospital/Winship Cancer Institute, Atlanta

32207

Baptist MD Anderson Cancer Center, Jacksonville

32610

University of Florida Health Science Center - Gainesville, Gainesville

32803

AdventHealth Orlando, Orlando

32806

Orlando Health Cancer Institute, Orlando

33486

Boca Raton Regional Hospital, Boca Raton

35233

University of Alabama at Birmingham Cancer Center, Birmingham

36608

Providence Hospital, Mobile

37232

Vanderbilt University/Ingram Cancer Center, Nashville

40202

Norton Hospital Pavilion and Medical Campus, Louisville

40241

Norton Brownsboro Hospital and Medical Campus, Louisville

40536

University of Kentucky/Markey Cancer Center, Lexington

43081

Saint Ann's Hospital, Westerville

43210

Ohio State University Comprehensive Cancer Center, Columbus

43214

Riverside Methodist Hospital, Columbus

43219

The Mark H Zangmeister Center, Columbus

43222

Mount Carmel Health Center West, Columbus

43560

ProMedica Flower Hospital, Sylvania

44106

Case Western Reserve University, Cleveland

44109

MetroHealth Medical Center, Cleveland

44124

Hillcrest Hospital Cancer Center, Mayfield Heights

44195

Cleveland Clinic Foundation, Cleveland

44691

Cleveland Clinic Wooster Family Health and Surgery Center, Wooster

46545

Memorial Regional Cancer Center Day Road, Mishawaka

46601

Memorial Hospital of South Bend, South Bend

46805

Parkview Hospital Randallia, Fort Wayne

46845

Parkview Regional Medical Center, Fort Wayne

48073

Corewell Health William Beaumont University Hospital, Royal Oak

48085

Corewell Health Beaumont Troy Hospital, Troy

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

48202

Henry Ford Hospital, Detroit

49007

West Michigan Cancer Center, Kalamazoo

49221

Bixby Medical Center, Adrian

49503

Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids

Trinity Health Grand Rapids Hospital, Grand Rapids

49519

University of Michigan Health - West, Wyoming

49684

Munson Medical Center, Traverse City

50010

McFarland Clinic - Ames, Ames

50266

Mercy Medical Center-West Lakes, West Des Moines

50309

Iowa Methodist Medical Center, Des Moines

Mission Cancer and Blood - Des Moines, Des Moines

50314

Broadlawns Medical Center, Des Moines

Mercy Medical Center - Des Moines, Des Moines

Mission Cancer and Blood - Laurel, Des Moines

50316

Iowa Lutheran Hospital, Des Moines

50325

Mercy Cancer Center-West Lakes, Clive

Mission Cancer and Blood - West Des Moines, Clive

50801

Greater Regional Medical Center, Creston

53066

ProHealth Oconomowoc Memorial Hospital, Oconomowoc

53149

ProHealth D N Greenwald Center, Mukwonago

53188

ProHealth Waukesha Memorial Hospital, Waukesha

UW Cancer Center at ProHealth Care, Waukesha

53215

Aurora Saint Luke's Medical Center, Milwaukee

53226

Medical College of Wisconsin, Milwaukee

54601

Gundersen Lutheran Medical Center, La Crosse

54806

Northwest Wisconsin Cancer Center, Ashland

55082

Lakeview Hospital, Stillwater

55101

Regions Hospital, Saint Paul

55102

United Hospital, Saint Paul

55109

Minnesota Oncology Hematology PA-Maplewood, Maplewood

Saint John's Hospital - Healtheast, Maplewood

55125

Minnesota Oncology Hematology PA-Woodbury, Woodbury

55337

Fairview Ridges Hospital, Burnsville

55379

Saint Francis Regional Medical Center, Shakopee

55387

Ridgeview Medical Center, Waconia

55407

Abbott-Northwestern Hospital, Minneapolis

55415

Hennepin County Medical Center, Minneapolis

55416

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park

55422

North Memorial Medical Health Center, Robbinsdale

55432

Unity Hospital, Fridley

55433

Mercy Hospital, Coon Rapids

55435

Fairview Southdale Hospital, Edina

55805

Essentia Health Cancer Center, Duluth

Miller-Dwan Hospital, Duluth

55905

Mayo Clinic in Rochester, Rochester

56201

Rice Memorial Hospital, Willmar

56303

Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud

57701

Rapid City Regional Hospital, Rapid City

58201

Altru Cancer Center, Grand Forks

59101

Billings Clinic Cancer Center, Billings

Saint Vincent Healthcare, Billings

59405

Benefis Sletten Cancer Institute, Great Falls

Great Falls Clinic, Great Falls

60068

Advocate Lutheran General Hospital, Park Ridge

60153

Loyola University Medical Center, Maywood

60525

AMITA Health Adventist Medical Center, La Grange

60611

Northwestern University, Chicago

60612

University of Illinois, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

61350

Illinois CancerCare-Ottawa Clinic, Ottawa

61354

Illinois CancerCare-Peru, Peru

Valley Radiation Oncology, Peru

61356

Illinois CancerCare-Princeton, Princeton

61401

Illinois CancerCare-Galesburg, Galesburg

Western Illinois Cancer Treatment Center, Galesburg

61443

Illinois CancerCare-Kewanee Clinic, Kewanee

61455

Illinois CancerCare-Macomb, Macomb

61520

Illinois CancerCare-Canton, Canton

61530

Illinois CancerCare-Eureka, Eureka

61554

Illinois CancerCare-Pekin, Pekin

OSF Saint Francis Radiation Oncology at Pekin, Pekin

61615

Illinois CancerCare-Peoria, Peoria

OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria

61636

Methodist Medical Center of Illinois, Peoria

61637

OSF Saint Francis Medical Center, Peoria

61704

Illinois CancerCare-Bloomington, Bloomington

62269

Cancer Care Center of O'Fallon, O'Fallon

62321

Illinois CancerCare-Carthage, Carthage

62401

Crossroads Cancer Center, Effingham

62526

Cancer Care Specialists of Illinois - Decatur, Decatur

Decatur Memorial Hospital, Decatur

62781

Memorial Medical Center, Springfield

62801

Centralia Oncology Clinic, Centralia

63110

Washington University School of Medicine, St Louis

63141

Mercy Hospital Saint Louis, St Louis

63703

Saint Francis Medical Center, Cape Girardeau

64064

University of Kansas Cancer Center - Lee's Summit, Lee's Summit

64116

University of Kansas Cancer Center at North Kansas City Hospital, North Kansas City

64154

University of Kansas Cancer Center - North, Kansas City

65212

MU Health - University Hospital/Ellis Fischel Cancer Center, Columbia

66160

University of Kansas Cancer Center, Kansas City

66205

University of Kansas Hospital-Westwood Cancer Center, Westwood

66210

University of Kansas Cancer Center-Overland Park, Overland Park

66211

University of Kansas Hospital-Indian Creek Campus, Overland Park

68046

Midlands Community Hospital, Papillion

68106

Missouri Valley Cancer Consortium, Omaha

68122

Alegent Health Immanuel Medical Center, Omaha

68124

Alegent Health Bergan Mercy Medical Center, Omaha

Nebraska Cancer Specialists - Omaha, Omaha

68130

Alegent Health Lakeside Hospital, Omaha

68198

University of Nebraska Medical Center, Omaha

68506

Nebraska Hematology and Oncology, Lincoln

68516

Cancer Partners of Nebraska, Lincoln

68803

Nebraska Cancer Specialists/Oncology Hematology West PC, Grand Island

68847

CHI Health Good Samaritan, Kearney

69361

Regional West Medical Center Cancer Center, Scottsbluff

69373

Centre Leon Berard, Lyon

70072

West Jefferson Medical Center, Marrero

73104

University of Oklahoma Health Sciences Center, Oklahoma City

74146

Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa

75235

Parkland Memorial Hospital, Dallas

75390

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

77573

UTMB Cancer Center at Victory Lakes, League City

80012

The Medical Center of Aurora, Aurora

80045

UCHealth University of Colorado Hospital, Aurora

80122

Littleton Adventist Hospital, Littleton

80138

Parker Adventist Hospital, Parker

80210

Porter Adventist Hospital, Denver

80228

Saint Anthony Hospital, Lakewood

80501

Longmont United Hospital, Longmont

80539

Banner McKee Medical Center, Loveland

80907

Penrose-Saint Francis Healthcare, Colorado Springs

Rocky Mountain Cancer Centers-Penrose, Colorado Springs

80909

UCHealth Memorial Hospital Central, Colorado Springs

80923

Saint Francis Cancer Center, Colorado Springs

81004

Saint Mary Corwin Medical Center, Pueblo

83605

Saint Alphonsus Cancer Care Center-Caldwell, Caldwell

83687

Saint Alphonsus Cancer Care Center-Nampa, Nampa

83854

Kootenai Clinic Cancer Services - Post Falls, Post Falls

84106

Utah Cancer Specialists-Salt Lake City, Salt Lake City

84107

Intermountain Medical Center, Murray

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

84143

LDS Hospital, Salt Lake City

84604

Utah Valley Regional Medical Center, Provo

84720

Sandra L Maxwell Cancer Center, Cedar City

84770

Saint George Regional Medical Center, St. George

85013

Saint Joseph's Hospital and Medical Center, Phoenix

85027

Arizona Oncology-Deer Valley Center, Phoenix

85260

Arizona Oncology Services Foundation, Scottsdale

87106

University of New Mexico Cancer Center, Albuquerque

89106

Radiation Oncology Centers of Nevada Central, Las Vegas

89109

GenesisCare USA - Las Vegas, Las Vegas

89119

Radiation Oncology Centers of Nevada Southeast, Las Vegas

89148

Comprehensive Cancer Centers of Nevada, Las Vegas

89169

Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas

89502

Renown Regional Medical Center, Reno

89503

Saint Mary's Regional Medical Center, Reno

89509

Radiation Oncology Associates, Reno

90027

Kaiser Permanente Los Angeles Medical Center, Los Angeles

90048

Cedars Sinai Medical Center, Los Angeles

91761

Kaiser Permanente-Ontario, Ontario

92093

UC San Diego Moores Cancer Center, La Jolla

92806

Kaiser Permanente-Anaheim, Anaheim

92868

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange

93611

Community Cancer Institute, Clovis

University Oncology Associates, Clovis

94010

Mills-Peninsula Medical Center, Burlingame

94080

Kaiser Permanente-South San Francisco, South San Francisco

94589

Sutter Solano Medical Center/Cancer Center, Vallejo

94611

Kaiser Permanente Oakland-Broadway, Oakland

94805

Gustave Roussy, Villejuif

95051

Kaiser Permanente Medical Center - Santa Clara, Santa Clara

95355

Memorial Medical Center, Modesto

95603

Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn

95661

Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville

Sutter Roseville Medical Center, Roseville

95682

Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park

95687

Sutter Cancer Centers Radiation Oncology Services-Vacaville, Vacaville

95816

Sutter Medical Center Sacramento, Sacramento

95817

University of California Davis Comprehensive Cancer Center, Sacramento

97015

Clackamas Radiation Oncology Center, Clackamas

97030

Legacy Mount Hood Medical Center, Gresham

97210

Legacy Good Samaritan Hospital and Medical Center, Portland

97213

Providence Portland Medical Center, Portland

97225

Providence Saint Vincent Medical Center, Portland

98101

Virginia Mason Medical Center, Seattle

98109

FHCC South Lake Union, Seattle

Fred Hutchinson Cancer Center, Seattle

98195

University of Washington Medical Center - Montlake, Seattle

98225

PeaceHealth Saint Joseph Medical Center, Bellingham

98274

Skagit Regional Health Cancer Care Center, Mount Vernon

Skagit Valley Hospital, Mount Vernon

98508

Anchorage Associates in Radiation Medicine, Anchorage

98664

PeaceHealth Southwest Medical Center, Vancouver

99336

Kadlec Clinic Hematology and Oncology, Kennewick

Tri-Cities Cancer Center, Kennewick

99508

Alaska Oncology and Hematology LLC, Anchorage

Alaska Women's Cancer Care, Anchorage

Anchorage Oncology Centre, Anchorage

Katmai Oncology Group, Anchorage

Providence Alaska Medical Center, Anchorage

06520

Yale University, New Haven

06611

Smilow Cancer Hospital Care Center-Trumbull, Trumbull

32224-9980

Mayo Clinic in Florida, Jacksonville

50266-7700

Methodist West Hospital, West Des Moines

04102

Maine Medical Center-Bramhall Campus, Portland

04074

Maine Medical Center- Scarborough Campus, Scarborough

Maine Medical Partners Neurology, Scarborough

04106

Maine Medical Partners - South Portland, South Portland

20889-5600

Walter Reed National Military Medical Center, Bethesda

20850-2062

Cancer Trials Support Unit, Rockville

02114

Massachusetts General Hospital Cancer Center, Boston

03756

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

07753

Jersey Shore Medical Center, Neptune City

08903

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick

Rutgers Cancer Institute of New Jersey, New Brunswick

07902

Overlook Hospital, Summit

77555-0565

University of Texas Medical Branch, Galveston

05819

Dartmouth Cancer Center - North, Saint Johnsbury

A-1090

Medical University Vienna, Vienna

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

V5Z 4E6

BCCA-Vancouver Cancer Centre, Vancouver

R3E 0V9

CancerCare Manitoba, Winnipeg

N6A 4L6

London Regional Cancer Program, London

K1H 8L6

Ottawa Hospital and Cancer Center-General Campus, Ottawa

M4N 3M5

Odette Cancer Centre- Sunnybrook Health Sciences Centre, Toronto

M5G 2M9

University Health Network-Princess Margaret Hospital, Toronto

H2L 4M1

CHUM - Hopital Notre-Dame, Montreal

H2X 3E4

CHUM - Centre Hospitalier de l'Universite de Montreal, Montreal

S4T 7T1

Allan Blair Cancer Centre, Regina

06189

Centre Antoine Lacassagne, Nice

1007 MB

Academ Zienkenhuis Bij De University, Amsterdam

9700 GZ

University Medical Center Groningen, Groningen

6229 NA

Maastro Clinic-Maastricht Radiation Oncology, Maastricht

3015 CE

Erasmus University Medical Center, Rotterdam

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

European Organisation for Research and Treatment Center (EORTC)

UNKNOWN

collaborator

Canadian Cancer Trials Group

NETWORK

lead

Alliance for Clinical Trials in Oncology

OTHER

NCT00887146 - Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma | Biotech Hunter | Biotech Hunter