Clinical Trial Finder

Inclusion Criteria:

• - Histopathologically confirmed newly diagnosed glioblastoma multiforme with WHO grade IV.

• - Histological diagnosis must be made locally after biopsy or neurosurgical tumor resection.

• - Four or more unstained tissue sections or a paraffin block must be provided to the Pathological Judgment Committee as tissue specimens.

• - Initial surgery/biopsy at diagnosis performed <=6 weeks (42 days) prior to treatment with temozolomide.

• - Age: >=18 and <=70 years.

• - ECOG performance status <=2.

• - Stable, non-increasing dose of corticosteroids over the 14 days prior to treatment with temozolomide.

• - No prior chemotherapy or radiotherapy.

• - Laboratory test values obtained within 14 days before initiation of administration of temozolomide must satisfy the following criteria: - absolute neutrophil count >= 1500/mm^3; - platelet count >= 100,000/mm^3; - serum creatinine <=1.5 times the upper limit of laboratory normal; - total bilirubin <=1.5 times the upper limit of laboratory normal; - glutamic oxaloacetic transaminase or glutamic pyruvic transaminase <2.5 times the upper limit of laboratory normal; - alkaline phosphatase < 2.5 times the upper limit of laboratory normal.

• - Absence of pathological conditions that interfere with taking oral drugs.

• - Contraception during the study period (from informed consent to the day of the last observation/examination of this study) is required in sexually active, potentially fertile patients, regardless of sex, under the supervision of the investigator or sub-investigator.

• - The investigator and/or subinvestigator must judge that life expectancy is 12 weeks or more.

• - Patients may be included regardless of sex or inpatient/outpatient.

Exclusion Criteria:

• - Extensively disseminated glioblastoma multiforme.

• - Severe disorders in the heart, liver, kidney, blood, etc. - Presence of previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and non melanoma skin cancer.

• - Women who are pregnant or lactating.

• - Women who may be pregnant or who could become pregnant and do not adopt contraception method(s).

• - Participation in another clinical study within 6 weeks prior to the initiation of administration of temozolomide.

• - Subjects who the investigator and/or subinvestigator judged inappropriate to participate in the study.

Arms

Experimental: Single arm

It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.

Interventions

Radiation: - Radiotherapy

Radiotherapy will be administered in combination with temozolomide during the concomitant radiotherapy phase. Radiotherapy will consist of a conventionally fractioned regimen, delivering a total dose of 60 Gy in 6 weeks, in a once daily schedule of 2 Gy per fraction, for a total of 30 fractions. Radiation will be provided by a linear accelerator of x ray energy of 4 MV or higher.

Drug: - Temozolomide

During the concomitant radiotherapy phase (6 weeks), temozolomide will be administered in combination with radiotherapy, once daily at 75 mg/m2/day. Then, during the monotherapy phase, subjects will receive 6 cycles of temozolomide alone. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m2/day, and may be increased to 200 mg/m2/day for Cycle 2 and subsequent cycles depending on nonhematologic toxicity observed and neutrophil and platelet count values. Capsules containing 5 mg, 20 mg, or 100 mg of temozolomide will be combined to achieve each subject's calculated dose.