Phase III Study on Radiation and Chemotherapy for Anaplastic Glioma Without 1p/19q Genetic Changes
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials ID:NCT00626990
This clinical trial is exploring whether combining radiation therapy with the chemotherapy drug temozolomide is more effective than radiation alone in treating patients with a type of brain tumor called anaplastic glioma that lacks certain genetic changes.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to find out if using the chemotherapy drug temozolomide along with radiation therapy can improve treatment outcomes for patients with anaplastic glioma, a type of brain tumor. Researchers want to see if this combination can help patients live longer and delay the progression of the disease compared to using radiation therapy alone.
Description
This study is testing different treatment approaches for patients with anaplastic glioma that does not have specific genetic changes known as 1p/19q loss of heterozygosity. The main goals are to see if adding the chemotherapy drug temozolomide to radiation therapy can help patients live longer and delay the worsening of their condition.
Patients in the study are divided into four groups:
- Group 1: Receives only radiation therapy once a day, five days a week, for about six and a half weeks.
- Group 2: Receives radiation therapy along with daily doses of temozolomide for the same period.
- Group 3: Receives radiation therapy, and then starts taking temozolomide about four weeks later, for five days every month, up to 12 months.
- Group 4: Receives both radiation therapy and temozolomide during the initial treatment, and continues with temozolomide after radiation, similar to Group 3.
The study will also look at how these treatments affect patients' quality of life and any side effects they experience. Patients will fill out questionnaires about their quality of life and mental function at different times during the study.
Tissue samples will be collected to help researchers understand more about the tumor's characteristics. After finishing the treatment, patients will have follow-up visits every three months to monitor their health and any changes in their condition.
Eligibility Criteria
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| 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 |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.