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Clinical Trials in Canada / NCT00626990
Active, not recruiting Phase 3

Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)

NCT00626990 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2007-12
Last updated
2023-09-11

Condition(s) studied

Brain and Central Nervous System Tumors

Investigational drug(s) / intervention(s)

temozolomide →DNA methylation analysislaboratory biomarker analysisadjuvant therapyquality-of-life assessmentradiation therapy

temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.

DNA methylation analysis: O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status is used for stratification at randomization.

laboratory biomarker analysis: Prognostic factor analyses

adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.

quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression

radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
120 Years
Healthy volunteers
No
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 PATIENT CHARACTERISTICS: * 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 PRIOR CONCURRENT THERAPY: * 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 * No other concurrent anticancer agents

Primary outcome measure(s)

Trial sites (132)

FacilityCityRegionStatus
Arizona Oncology Services Foundation Phoenix Arizona
Cedars-Sinai Medical Center Los Angeles California
UCSF University of California San Francisco Medical Center-Mount Zion San Francisco California
University of Florida Gainesville Florida
Mayo Clinic in Florida Jacksonville Florida
Florida Hospital Orlando Florida
Emory University Atlanta Georgia
Memorial Health University Medical Center Savannah Georgia
Northwestern University Chicago Illinois
Loyola University Medical Center Maywood Illinois
Oncology Associates PC Fort Wayne Indiana
Parkview Hospital Fort Wayne Indiana
Saint Vincent Oncology Center Indianapolis Indiana
McFarland Clinic Ames Iowa
June E. Nylen Cancer Center Sioux City Iowa
Via Christi Regional Medical Center Wichita Kansas
Wesley Medical Center Wichita Kansas
Maine Medical Center Scarborough Maine
Boston Medical Center Boston Massachusetts
Brigham and Women's Hospital Boston Massachusetts
Massachussets General Hospital Cancer Center Boston Massachusetts
Saint Joseph Mercy Hospital Ann Arbor Michigan
Henry Ford Hospital Detroit Michigan
West Michigan Cancer Center Kalamazoo Michigan
St John's Mercy Medical Center St Louis Missouri
Methodist Estabrook Cancer Center Omaha Nebraska
Dartmouth Hitchcock Medical Center Lebanon New Hampshire
State University of New York Upstate Medical University New York New York
Highland Hospital Rochester New York
University of Rochester - James P. Wilmot Cancer Center Rochester New York
Carolinas Medical Center Charlotte North Carolina
Akron City Hospital - Summa Health System Akron Ohio
Summa Barberton Hospital Barberton Ohio
Cleveland Clinic Foundation Cleveland Ohio
MetroHealth Medical Center Cleveland Ohio
Western Reserve University Cleveland Ohio
Ohio State University Medical Center Columbus Ohio
Southwest General Health Center Ireland Cancer Center Middleburg Heights Ohio
UHHS-Chagrin Highlands Medical Center Orange Ohio
Cancer Care Center, Incorporated Salem Ohio

+ 92 more sites — see the full list on the official registry below.

More European Organisation for Research and Treatment of Cancer - EORTC trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00626990 on ClinicalTrials.gov ↗ ← All trials in Canada