Neoplasms

All Conditions

Rare Diseases

Glioma

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients treated with temozolomide for newly diagnosed malignant glioma

Patients treated with temozolomide for relapsed malignant glioma

Patients treated with temozolomide for newly diagnosed anaplastic astrocytoma

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 (for newly diagnosed 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.

Temozolomide (for relapsed 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.

Radiotherapy (for patients with newly diagnosed malignant glioma)

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.

Patients are invited to participate in the study.

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Temozolomide All-Case-Registered Surveillance (Designated Drug Use Investigation)(Study P05062)	NCT00705198	Glioma Astrocytoma	Temozolomide (f... Temozolomide (f... Radiotherapy (f...	-	Merck Sharp & Dohme LLC
Temozolomide All-Case-Registered Surveillance (Designated Drug Use Investigation)(Study P05062)	NCT00705198	Glioma Astrocytoma	Temozolomide (f... Temozolomide (f... Radiotherapy (f...	-	Merck Sharp & Dohme LLC

Spots Global Cancer Trial Database for temozolomide (for newly diagnosed malignant glioma)