Status:
ACTIVE_NOT_RECRUITING
Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Collaborating Sponsors:
NCIC Clinical Trials Group
Radiation Therapy Oncology Group
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18-120 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2029
Estimated Enrollment :
751 Patients enrolled
Trial Details
Trial ID
NCT00626990
Start Date
December 1 2007
End Date
December 1 2029
Last Update
September 11 2023
Active Locations (132)
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1
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
2
Cedars-Sinai Medical Center
Los Angeles, California, United States
3
UCSF University of California San Francisco Medical Center-Mount Zion
San Francisco, California, United States
4
University of Florida
Gainesville, Florida, United States