Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Overall Survival as Measured From the Day of Randomization — from date from enrollment till the date of death (time till death is up to 10.9 years after patient enrollment in the study)
The duration of survival is the time interval between randomization and the date of death due to any cause. Patients not reported dead or lost to follow up will be censored at the date of the last follow up examination.
Trial sites (132)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Italy
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 Italy