Clinical trial NCT00705198: Temozolomide All-Case-Registered Surveillance (Designated Drug Use Investigation)(Study P05062)
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioma
Astrocytoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-25
Enrollment: 1804
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with temozolomide for newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy). In addition, up to 450 patients with newly diagnosed anaplastic astrocytoma will be registered to investigate survival time.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* All patients treated with temozolomide for newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy).

Exclusion Criteria:

* Patients with a history of hypersensitivity to temozolomide or dacarbazine.
* Pregnant women and women who may be pregnant.

Primary outcomes:
measure: Safety: observation of hematology, biochemistry, and adverse events (AEs); evaluation of details of occurrence of AEs and unexpected serious AEs, and evaluation of presence or absence of secondary malignancies and causal relationship with temozolomide.
timeFrame: AEs during treatment with temozolomide, serious AEs occurring within 30 days after completion of treatment with temozolomide. Secondary malignancies will be monitored from the start of treatment with temozolomide to final outcome.
measure: Efficacy in patients registered during Period 1, evaluated as Remarkably Effective, Moderately Effective, Stable Disease, Progression, or Not Evaluable, considering tumor responses, progression free survival, overall survival, among other factors.
timeFrame: One year after start of temozolomide treatment.
measure: Efficacy in all newly diagnosed anaplastic astrocytoma patients:, evaluated as 5 year survival rate and overall survival.
timeFrame: From the start of treatment with temozolomide to final outcome.
Secondary outcomes:
Other outcomes:
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