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

Study Overview
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Brief Summary
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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
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Patients are invited to participate in the study.

Official Title
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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)

Conditions
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Glioma, Astrocytoma

Intervention / Treatment
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* Drug: Temozolomide (for newly diagnosed malignant glioma)
* Drug: Temozolomide (for relapsed malignant glioma)
* Radiation: Radiotherapy (for patients with newly diagnosed malignant glioma)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newly diagnosed patients<br>Patients treated with temozolomide for newly diagnosed malignant glioma | Drug: Temozolomide (for newly diagnosed malignant glioma)<br>* 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.<br>* Other names: SCH 052365;Radiation: Radiotherapy (for patients with newly diagnosed malignant glioma)<br>* 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.<br>* Other names: Radiation therapy;|
| Relapsed patients<br>Patients treated with temozolomide for relapsed malignant glioma | Drug: Temozolomide (for relapsed malignant glioma)<br>* 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.<br>* Other names: SCH 052365;|
| Newly diagnosed anaplastic astrocytoma patients<br>Patients treated with temozolomide for newly diagnosed anaplastic astrocytoma | Drug: Temozolomide (for newly diagnosed malignant glioma)<br>* 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.<br>* Other names: SCH 052365;Radiation: Radiotherapy (for patients with newly diagnosed malignant glioma)<br>* 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.<br>* Other names: Radiation therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 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. | 
| 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. |  | One year after start of temozolomide treatment. | 
| Efficacy in all newly diagnosed anaplastic astrocytoma patients:, evaluated as 5 year survival rate and overall survival. |  | From the start of treatment with temozolomide to final outcome. |