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Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)
Study Purpose
RATIONALE: 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. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma. PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
DISEASE CHARACTERISTICS:
- - Histologically confirmed diagnosis of 1 of the following: - Anaplastic oligodendroglioma.
- - Anaplastic oligoastrocytoma.
- - Anaplastic astrocytoma.
- - Newly diagnosed disease.
- - Prior surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression.
- - Absence of combined 1p/19q loss.
- - Tumor material available for central 1p/19q assessment, central O6-methylguanine-DNA methyltransferase promoter methylation status assessment, isocitrate dehydrogenase mutation analysis, and central pathology review.
- - Patients must be on a stable or decreasing dose of steroids for at least two weeks prior to randomization.
- - WHO performance status 0-2.
- - Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9 cells/L.
- - Platelet count ≥ 100 x 10^9 cells/L.
- - Bilirubin < 1.5 x upper limit of normal (ULN) - Alkaline phosphatase < 2.5 x ULN.
- - Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2.5 x ULN.
- - Serum creatinine < 1.5 x ULN.
- - Not pregnant or nursing.
- - Fertile patients must use effective contraception.
- - No known HIV infection or chronic hepatitis B or hepatitis C infection.
- - No other serious medical condition that would interfere with follow-up.
- - No medical condition that could interfere with oral medication intake (e.g., frequent vomiting or partial bowel obstruction) - No other prior malignancies except for any malignancy which was treated with curative intent more than 5 years prior to registration and adequately controlled limited basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- - No prior or concurrent malignancies at other sites except for surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer.
- - No psychological, familial, sociological, or geographical condition that would potentially hamper compliance with the study protocol and follow-up schedule.
- - See Disease Characteristics.
- - No prior chemotherapy, including carmustine-containing wafers (Gliadel®) - No prior radiotherapy to the brain.
- - No concurrent growth factors unless vital for the patient.
- - No other concurrent investigational treatment.
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT00626990 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
European Organisation for Research and Treatment of Cancer - EORTC |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Wolfgang WickWarren P. Mason, MDMichael A. Vogelbaum, MD, PhDS. ErridgeAnna Nowak, MD |
| Principal Investigator Affiliation | Universitatsklinikum HeidelbergPrincess Margaret Hospital, CanadaThe Cleveland ClinicMedical Research CouncilSir Charles Gairdner Hospital - Nedlands |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, Industry |
| Overall Status | Active, not recruiting |
| Countries | Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Brain and Central Nervous System Tumors |
| Study Website: | View Trial Website |
OBJECTIVES: Primary.
- - To assess whether concurrent radiotherapy with daily temozolomide improves overall survival as compared to no daily temozolomide in patients with non-1p/19q deleted anaplastic glioma.
- - To assess whether adjuvant temozolomide improves survival as compared to no adjuvant temozolomide in patients with non-1p/19q deleted anaplastic glioma.
- - To assess whether concurrent and adjuvant temozolomide prolongs progression-free survival and neurological deterioration-free survival in patients with non-1p/19q deleted anaplastic glioma.
- - To assess the safety of concurrent and adjuvant temozolomide in patients with non-1p/19q deleted anaplastic glioma, including late effects on cognition.
- - To assess the impact of concurrent and adjuvant temozolomide on the quality of life of patients with non-1p/19q deleted anaplastic glioma.
- - Arm I: Patients undergo radiotherapy* once daily, 5 days a week, for 6.5 weeks (total of 33 fractions).
- - Arm II: Patients undergo radiotherapy* once daily, 5 days a week and receive oral temozolomide once daily for 6.5 weeks (total of 33 fractions of radiotherapy).
- - Arm III: Patients undergo radiotherapy* once daily, 5 days a week for 6.5 weeks (total of 33 fractions).
- - Arm IV: Patients undergo radiotherapy* once daily, 5 days a week and receive oral temozolomide once daily for 6.5 weeks (total of 33 fractions of radiotherapy).
- - Patients must begin radiotherapy within 8 days after randomization and within 7 weeks after surgery.
Arms
Active Comparator: Radiotherapy (RT) alone
radiation therapy alone
Active Comparator: RT & Concurrent CT
Radiotherapy and concurrent temozolomide chemotherapy
Active Comparator: RT + Adjuvant CT
Radiotherapy plus adjuvant temozolomide chemotherapy
Active Comparator: RT & Concurrent CT + adjuvant CT
Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy
Interventions
Drug: - temozolomide
Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
Genetic: - DNA methylation analysis
O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status is used for stratification at randomization.
Other: - laboratory biomarker analysis
Prognostic factor analyses
Procedure: - adjuvant therapy
Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.
Procedure: - quality-of-life assessment
Quality of Life analysis will also be used to assess neurological deterioration free progression
Radiation: - radiation therapy
Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Arizona Oncology Services Foundation
Phoenix 5308655, Arizona 5551752,
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Address
Cedars-Sinai Medical Center
Los Angeles 5368361, California 5332921,
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Address
UCSF University of California San Francisco Medical Center-Mount Zion
San Francisco 5391959, California 5332921,
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Address
University of Florida
Gainesville 4156404, Florida 4155751,
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Address
Mayo Clinic in Florida
Jacksonville 4160021, Florida 4155751,
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Address
Florida Hospital
Orlando 4167147, Florida 4155751,
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Address
Emory University
Atlanta 4180439, Georgia 4197000,
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Address
Memorial Health University Medical Center
Savannah 4221552, Georgia 4197000,
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Address
Northwestern University
Chicago 4887398, Illinois 4896861,
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Address
Loyola University Medical Center
Maywood 4901514, Illinois 4896861,
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Address
Oncology Associates PC
Fort Wayne 4920423, Indiana 4921868,
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Address
Parkview Hospital
Fort Wayne 4920423, Indiana 4921868,
Status
Address
Saint Vincent Oncology Center
Indianapolis 4259418, Indiana 4921868,
Status
Address
McFarland Clinic
Ames 4846834, Iowa 4862182, 50010
Status
Address
June E. Nylen Cancer Center
Sioux City 4876523, Iowa 4862182,
Status
Address
Via Christi Regional Medical Center
Wichita 4281730, Kansas 4273857,
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Address
Wesley Medical Center
Wichita 4281730, Kansas 4273857,
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Address
Maine Medical Center
Scarborough 4977882, Maine 4971068,
Status
Address
Boston Medical Center
Boston 4930956, Massachusetts 6254926,
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Address
Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926,
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Address
Massachussets General Hospital Cancer Center
Boston 4930956, Massachusetts 6254926,
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Address
Saint Joseph Mercy Hospital
Ann Arbor 4984247, Michigan 5001836,
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Address
Henry Ford Hospital
Detroit 4990729, Michigan 5001836,
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Address
West Michigan Cancer Center
Kalamazoo 4997787, Michigan 5001836,
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Address
St John's Mercy Medical Center
St Louis 4407066, Missouri 4398678,
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Address
Methodist Estabrook Cancer Center
Omaha 5074472, Nebraska 5073708,
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Address
Dartmouth Hitchcock Medical Center
Lebanon 5088597, New Hampshire 5090174,
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Address
State University of New York Upstate Medical University
New York 5128581, New York 5128638,
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Address
Highland Hospital
Rochester 5134086, New York 5128638,
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Address
University of Rochester - James P. Wilmot Cancer Center
Rochester 5134086, New York 5128638,
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Address
Carolinas Medical Center
Charlotte 4460243, North Carolina 4482348,
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Address
Akron City Hospital - Summa Health System
Akron 5145476, Ohio 5165418,
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Address
Summa Barberton Hospital
Barberton 5146491, Ohio 5165418,
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Address
Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418,
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Address
MetroHealth Medical Center
Cleveland 5150529, Ohio 5165418,
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Address
Western Reserve University
Cleveland 5150529, Ohio 5165418,
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Address
Ohio State University Medical Center
Columbus 4509177, Ohio 5165418,
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Address
Southwest General Health Center Ireland Cancer Center
Middleburg Heights 5162851, Ohio 5165418,
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Address
UHHS-Chagrin Highlands Medical Center
Orange 5165695, Ohio 5165418,
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Address
Cancer Care Center, Incorporated
Salem 5170511, Ohio 5165418,
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Address
UHHS - Westlake Medical Center
Westlake 5176517, Ohio 5165418,
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Cancer Treatment Center
Wooster 5177358, Ohio 5165418,
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Abington Memorial Hospital
Abington 5177773, Pennsylvania 6254927,
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Lehigh Valley Hospital
Allentown 5178127, Pennsylvania 6254927,
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Address
UPMC - Heritage Valley Health System - The Medical Center
Beaver 5179446, Pennsylvania 6254927,
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Penn State M.S. Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927,
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Address
Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927,
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Reading Hospital and Medical Center
West Reading 5218867, Pennsylvania 6254927,
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Address
Medical University of South Carolina
Charleston 4574324, South Carolina 4597040,
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Address
Cancer Centers of the Carolinas - Eastside
Greenville 4580543, South Carolina 4597040,
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Address
Cancer Centers of the Carolinas - Faris Road
Greenville 4580543, South Carolina 4597040,
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Address
Cancer Centers of the Carolinas - Greer Radiation Oncology
Greer 4580599, South Carolina 4597040,
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Address
Cancer Centers of the Carolinas - Seneca
Seneca 4595346, South Carolina 4597040,
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Address
Spartanburg Regional Medical Center
Spartanburg 4597200, South Carolina 4597040,
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Address
Rapid City Regional Hospital
Rapid City 5768233, South Dakota 5769223,
Status
Address
University of Texas Medical Branch
Galveston 4692883, Texas 4736286,
Status
Address
Md Anderson Cancer Center
Houston 4699066, Texas 4736286,
Status
Address
Methodist Hospital
Houston 4699066, Texas 4736286,
Status
Address
Intermountain Medical Center
Murray 5778755, Utah 5549030,
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Address
Utah Valley Regional Medical Center
Provo 5780026, Utah 5549030,
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Address
LDS Hospital
Salt Lake City 5780993, Utah 5549030,
Status
Address
University Of Utah - Huntsman Cancer Institute
Salt Lake City 5780993, Utah 5549030,
Status
Address
Dixie Medical Center Regional Cancer Center
St. George 5546220, Utah 5549030,
Status
Address
Virginia Commonwealth University
Richmond 4781708, Virginia 6254928,
Status
Address
Swedish Cancer Institute
Seattle 5809844, Washington 5815135,
Status
Address
Virginia Mason CCOP
Seattle 5809844, Washington 5815135,
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Address
Saint Mary's Hospital
Green Bay 5254962, Wisconsin 5279468,
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Address
Saint Vincent Hospital
Green Bay 5254962, Wisconsin 5279468,
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Address
Gundersen Lutheran
La Crosse 5258957, Wisconsin 5279468,
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Address
University Of Wisconsin Comprehensive Cancer Center
Madison 5261457, Wisconsin 5279468,
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Address
Froedtert and the Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468,
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Address
Waukesha Memorial Hospital
Waukesha 5278052, Wisconsin 5279468,
International Sites
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Address
Royal North Shore Hospital
St Leonards 8029783, New South Wales 2155400, 2065
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Royal Prince Alfred Hospital
Sydney 2147714, New South Wales 2155400, 2050
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Princess Alexandra Hospital
Brisbane 2174003, Queensland 2152274, 4102
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Royal Melbourne Hospital
Parkville 2153770, Victoria 2145234, 3050
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Flinders Medical Centre
Bedford Park 2076918, ,
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Austin-Repatriation Medical Centre
Heidelberg 2163654, ,
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Royal Hobart Hospital
Hobart 2163355, ,
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St Vincent'S Hospital
Melbourne 2158177, ,
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Sir Charles Gairdner Hospital
Nedlands 2064874, ,
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Alfred Hospital
Prahran 2152593, ,
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ZNA Middelheim
Antwerp 2803138, ,
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Cliniques Universitaires St. Luc
Brussels 2800866, ,
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Universitair Ziekenhuis Brussel
Brussels 2800866, ,
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Clinique Notre-Dame
Charleroi 2800481, ,
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Algemeen Ziekenhuis Sint Lucas
Ghent 2797656, ,
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U.Z. Gasthuisberg
Leuven 2792482, ,
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Tom Baker Cancer Centre
Calgary 5913490, ,
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London Regional Cancer Center
London 6058560, ,
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Allan Blair Cancer Centre
Saskatoon 6141256, ,
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University Health Network - Oci / Princess Margaret Hospital
Toronto 6167865, ,
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Cancercare Manitoba
Winnipeg 6183235, ,
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Assistance Publique - Hôpitaux de Marseille - C.H.U. De La Timone
Marseille 2995469, ,
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C.H.U. de Nancy - Hopital St Julien
Nancy 2990999, ,
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Centre Antoine Lacassagne
Nice 2990440, ,
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Chu Pitie-Salpetriere AP-HP
Paris 2988507, ,
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Centre Eugene Marquis
Rennes 2983990, ,
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Institut Gustave Roussy
Villejuif 2968705, ,
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Klinikum Bamberg
Bamberg 2952984, ,
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Universitaetsklinikum Bonn
Bonn 2946447, ,
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Medizinische Hochschule Hannover
Hanover 2910831, ,
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UniversitaetsKlinikum Heidelberg
Heidelberg 2907911, ,
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Universitaetskliniken Regensburg
Regensburg 2849483, ,
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Universitaetsklinikum Tuebingen
Tübingen 2820860, ,
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Tel Aviv Sourasky Medical Center
Tel Aviv 293397, ,
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Ospedale Bellaria
Bologna 3181928, ,
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Istituto Scientifico H.S. Raffaele
Milan 6951411, ,
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Azienda Ospedaliera San Giovanni Battista Di Torino-Universita Di Torino
Torino 8980539, ,
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Academisch Medisch Centrum - Universiteit van Amsterdam
Amsterdam 2759794, ,
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Vrije Universiteit Medisch Centrum
Amsterdam 2759794, ,
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University Medical Center Groningen
Groningen 2755251, ,
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Maastro Clinic - Maastricht Radiation Oncology
Maastricht 2751283, ,
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Radboud University Nijmegen Medical Centre
Nijmegen 2750053, ,
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Erasmus MC - Daniel den Hoed Cancer Center
Rotterdam 2747891, ,
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Medisch Centrum Haaglanden - Westeinde
The Hague 2747373, ,
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Hospital Clinic Universitari
Barcelona 3128760, ,
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ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
Barcelona 3128760, ,
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Hopital Cantonal Universitaire De Geneve
Geneva 2660646, ,
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Universitaetsspital
Zurich 2657896, ,
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University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
Bristol 2654675, ,
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Addenbrookes Hospital
Cambridge 2653941, ,
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Cheltenham General Hospital
Cheltenham 2653261, ,
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Western General Hospital
Edinburgh 2650225, ,
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Royal Devon And Exeter Hospital
Exeter 2649808, ,
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St. James'S University Hospital
Leeds 2644688, ,
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Christie NHS Foundation Trust
Manchester 2643123, ,
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Clatterbridge Centre for Oncology NHS Trust
Metropolitan Borough of Wirral 7733088, ,
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Nottingham University Hospitals NHS Trust - City Hospital campus
Nottingham 2641170, ,
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Derriford Hospital
Plymouth 2640194, ,
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Weston Park Hospital
Sheffield 2638077, ,
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Royal Marsden Hospital
Sutton 2636503, ,
