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Spots Global Cancer Trial Database for Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Kurt Jaeckle, MD

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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