Temozolomide All-Case-Registered Surveillance (Designated Drug Use Investigation)(Study P05062)

"Temozolomide treatment for newly diagnosed malignant glioma. The usual dose for adults in combination with radiotherapy is 75 mg/m2 orally once daily for 42 consecutive days. After a 4 week rest period, monotherapy at 150 mg/m2 orally once daily for 5 consecutive days per 28 day treatment cycle is administered. The dose may be increased to 200 mg/m2 for the next 28 day treatment cycle.~Temozolomide is administered as 20 mg and 100 mg capsules."

"Temozolomide treatment for relapsed malignant glioma. The usual dose for adults is 150 mg/m2 orally once daily for 5 consecutive days per 28 day treatment cycle. The dose may be increased to 200 mg/m2 for the next 28 day treatment cycle.~Temozolomide is administered as 20 mg and 100 mg capsules."

Although the study protocol does not clearly define how long this intervention is applied, radiotherapy is generally administered 5 days/week for 6 weeks to patients with newly diagnosed malignant glioma.