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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.
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Arizona Oncology Services Foundation
Phoenix, Arizona,
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Cedars-Sinai Medical Center
Los Angeles, California,
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UCSF University of California San Francisco Medical Center-Mount Zion
San Francisco, California,
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University of Florida
Gainesville, Florida,
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Mayo Clinic in Florida
Jacksonville, Florida,
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Florida Hospital
Orlando, Florida,
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Emory University
Atlanta, Georgia,
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Memorial Health University Medical Center
Savannah, Georgia,
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Northwestern University
Chicago, Illinois,
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Loyola University Medical Center
Maywood, Illinois,
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Oncology Associates PC
Fort Wayne, Indiana,
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Parkview Hospital
Fort Wayne, Indiana,
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Saint Vincent Oncology Center
Indianapolis, Indiana,
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McFarland Clinic
Ames, Iowa, 50010
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June E. Nylen Cancer Center
Sioux City, Iowa,
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Via Christi Regional Medical Center
Wichita, Kansas,
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Wesley Medical Center
Wichita, Kansas,
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Maine Medical Center
Scarborough, Maine,
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Boston Medical Center
Boston, Massachusetts,
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Brigham and Women's Hospital
Boston, Massachusetts,
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Massachussets General Hospital Cancer Center
Boston, Massachusetts,
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Saint Joseph Mercy Hospital
Ann Arbor, Michigan,
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Henry Ford Hospital
Detroit, Michigan,
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West Michigan Cancer Center
Kalamazoo, Michigan,
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St John's Mercy Medical Center
Saint Louis, Missouri,
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Methodist Estabrook Cancer Center
Omaha, Nebraska,
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Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire,
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State University of New York Upstate Medical University
New York, New York,
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Highland Hospital
Rochester, New York,
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University of Rochester - James P. Wilmot Cancer Center
Rochester, New York,
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Carolinas Medical Center
Charlotte, North Carolina,
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Akron City Hospital - Summa Health System
Akron, Ohio,
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Summa Barberton Hospital
Barberton, Ohio,
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Cleveland Clinic Foundation
Cleveland, Ohio,
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MetroHealth Medical Center
Cleveland, Ohio,
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Western Reserve University
Cleveland, Ohio,
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Ohio State University Medical Center
Columbus, Ohio,
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Southwest General Health Center Ireland Cancer Center
Middleburg Heights, Ohio,
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UHHS-Chagrin Highlands Medical Center
Orange Village, Ohio,
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Cancer Care Center, Incorporated
Salem, Ohio,
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UHHS - Westlake Medical Center
Westlake, Ohio,
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Cancer Treatment Center
Wooster, Ohio,
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Abington Memorial Hospital
Abington, Pennsylvania,
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Lehigh Valley Hospital
Allentown, Pennsylvania,
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UPMC - Heritage Valley Health System - The Medical Center
Beaver, Pennsylvania,
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Penn State M.S. Hershey Medical Center
Hershey, Pennsylvania,
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania,
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Reading Hospital and Medical Center
West Reading, Pennsylvania,
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Medical University of South Carolina
Charleston, South Carolina,
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Cancer Centers of the Carolinas - Eastside
Greenville, South Carolina,
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Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina,
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Cancer Centers of the Carolinas - Greer Radiation Oncology
Greer, South Carolina,
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Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina,
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Spartanburg Regional Medical Center
Spartanburg, South Carolina,
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Rapid City Regional Hospital
Rapid City, South Dakota,
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University of Texas Medical Branch
Galveston, Texas,
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Md Anderson Cancer Center
Houston, Texas,
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Methodist Hospital
Houston, Texas,
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Intermountain Medical Center
Murray, Utah,
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Utah Valley Regional Medical Center
Provo, Utah,
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Dixie Medical Center Regional Cancer Center
Saint George, Utah,
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LDS Hospital
Salt Lake City, Utah,
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University Of Utah - Huntsman Cancer Institute
Salt Lake City, Utah,
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Virginia Commonwealth University
Richmond, Virginia,
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Swedish Cancer Institute
Seattle, Washington,
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Virginia Mason CCOP
Seattle, Washington,
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Saint Mary's Hospital
Green Bay, Wisconsin,
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Saint Vincent Hospital
Green Bay, Wisconsin,
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Gundersen Lutheran
La Crosse, Wisconsin,
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University Of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin,
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Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin,
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Waukesha Memorial Hospital
Waukesha, Wisconsin,
International Sites
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Royal North Shore Hospital
St. Leonards, New South Wales, 2065
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Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
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Princess Alexandra Hospital
Brisbane, Queensland, 4102
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Royal Melbourne Hospital
Parkville, Victoria, 3050
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Flinders Medical Centre
Bedford Park, ,
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Austin-Repatriation Medical Centre
Heidelberg, ,
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Royal Hobart Hospital
Hobart, ,
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St Vincent'S Hospital
Melbourne, ,
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Sir Charles Gairdner Hospital
Nedlands, ,
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Alfred Hospital
Prahran, ,
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ZNA Middelheim
Antwerpen, ,
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Cliniques Universitaires St. Luc
Brussels, ,
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Universitair Ziekenhuis Brussel
Brussels, ,
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Clinique Notre-Dame
Charleroi, ,
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Algemeen Ziekenhuis Sint Lucas
Gent, ,
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U.Z. Gasthuisberg
Leuven, ,
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Tom Baker Cancer Centre
Calgary, ,
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London Regional Cancer Center
London, ,
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Allan Blair Cancer Centre
Saskatoon, ,
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University Health Network - Oci / Princess Margaret Hospital
Toronto, ,
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Cancercare Manitoba
Winnipeg, ,
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Assistance Publique - Hôpitaux de Marseille - C.H.U. De La Timone
Marseille, ,
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C.H.U. de Nancy - Hopital St Julien
Nancy, ,
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Centre Antoine Lacassagne
Nice, ,
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Chu Pitie-Salpetriere AP-HP
Paris, ,
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Centre Eugene Marquis
Rennes, ,
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Institut Gustave Roussy
Villejuif, ,
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Klinikum Bamberg
Bamberg, ,
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Universitaetsklinikum Bonn
Bonn, ,
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Medizinische Hochschule Hannover
Hannover, ,
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UniversitaetsKlinikum Heidelberg
Heidelberg, ,
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Universitaetskliniken Regensburg
Regensburg, ,
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Universitaetsklinikum Tuebingen
Tuebingen, ,
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Tel Aviv Sourasky Medical Center
Tel Aviv, ,
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Ospedale Bellaria
Bologna, ,
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Istituto Scientifico H.S. Raffaele
Milano, ,
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Azienda Ospedaliera San Giovanni Battista Di Torino-Universita Di Torino
Torino, ,
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Academisch Medisch Centrum - Universiteit van Amsterdam
Amsterdam, ,
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Vrije Universiteit Medisch Centrum
Amsterdam, ,
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Medisch Centrum Haaglanden - Westeinde
Den Haag, ,
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University Medical Center Groningen
Groningen, ,
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Maastro Clinic - Maastricht Radiation Oncology
Maastricht, ,
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Radboud University Nijmegen Medical Centre
Nijmegen, ,
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Erasmus MC - Daniel den Hoed Cancer Center
Rotterdam, ,
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Hospital Clinic Universitari
Barcelona, ,
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ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
Barcelona, ,
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Hopital Cantonal Universitaire De Geneve
Geneve, ,
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Universitaetsspital
Zurich, ,
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University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
Bristol, ,
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Addenbrookes Hospital
Cambridge, ,
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Cheltenham General Hospital
Cheltenham, ,
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Western General Hospital
Edinburgh, ,
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Royal Devon And Exeter Hospital
Exeter, ,
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St. James'S University Hospital
Leeds, ,
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Christie NHS Foundation Trust
Manchester, ,
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Nottingham University Hospitals NHS Trust - City Hospital campus
Nottingham, ,
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Derriford Hospital
Plymouth, ,
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Weston Park Hospital
Sheffield, ,
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Royal Marsden Hospital
Sutton, ,
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Clatterbridge Centre for Oncology NHS Trust
Wirral, ,
