NCT00626990
Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)
PHASE3
ACTIVE_NOT_RECRUITING
NCT00626990
INTERVENTIONAL
Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.
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.
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
Brain and Central Nervous System Tumors
- TREATMENT
-
- Type: DRUG
- Name: temozolomide
- Description: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
- Arm Group Labels: RT & Concurrent CT, RT & Concurrent CT + adjuvant CT, RT + Adjuvant CT
-
- Type: GENETIC
- Name: DNA methylation analysis
- Description: O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status is used for stratification at randomization.
- Arm Group Labels: RT & Concurrent CT, RT & Concurrent CT + adjuvant CT, RT + Adjuvant CT, Radiotherapy (RT) alone
-
- Type: OTHER
- Name: laboratory biomarker analysis
- Description: Prognostic factor analyses
- Arm Group Labels: RT & Concurrent CT, RT & Concurrent CT + adjuvant CT, RT + Adjuvant CT, Radiotherapy (RT) alone
-
- Type: PROCEDURE
- Name: adjuvant therapy
- Description: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.
- Arm Group Labels: RT & Concurrent CT + adjuvant CT, RT + Adjuvant CT
-
- Type: PROCEDURE
- Name: quality-of-life assessment
- Description: Quality of Life analysis will also be used to assess neurological deterioration free progression
- Arm Group Labels: RT & Concurrent CT, RT & Concurrent CT + adjuvant CT, RT + Adjuvant CT, Radiotherapy (RT) alone
-
- Type: RADIATION
- Name: radiation therapy
- Description: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
- Arm Group Labels: RT & Concurrent CT, RT & Concurrent CT + adjuvant CT, RT + Adjuvant CT, Radiotherapy (RT) alone
- European Organisation for Research and Treatment of Cancer - EORTC