NCT00705198

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

Temodal Capsule All-Case-Registered Surveillance (Designated Drug Use Investigation) - Evaluation of The Safety and Efficacy of Temodal in Patients With Newly Diagnosed Malignant Glioma (Concomitant With Radiotherapy and Then as Monotherapy) and Relapsed Malignant Glioma (as Monotherapy)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,804 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to confirm the safety and efficacy of temozolomide in patients with newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy) when used in the daily medical practices. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Detailed description

Patients are invited to participate in the study.

Conditions

• Glioma
• Astrocytoma

Interventions

Type	Name	Description
DRUG	Temozolomide (for newly diagnosed malignant glioma)	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.
DRUG	Temozolomide (for relapsed malignant glioma)	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.
RADIATION	Radiotherapy (for patients with newly diagnosed malignant glioma)	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.

Timeline

• Start date: 2006-09-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2008-06-25
• Last updated: 2016-11-15