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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	June 23, 2008
Last Updated Date	May 6, 2009
Start Date ^†	September 2006
Current Primary Outcome Measures ^† (submitted: June 24, 2008)	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. [ Time Frame: 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. ] [ Designated as safety issue: Yes ] 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. [ Time Frame: One year after start of temozolomide treatment. ] [ Designated as safety issue: No ] Efficacy in all newly diagnosed anaplastic astrocytoma patients:, evaluated as 5 year survival rate and overall survival. [ Time Frame: From the start of treatment with temozolomide to final outcome. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00705198 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	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)
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.
Detailed Description	Patients are invited to participate in the study.
Study Phase
Study Type ^†	Observational
Study Design ^†	Cohort, Prospective
Condition ^†	Glioma Astrocytoma
Intervention ^†	Drug: Temozolomide (for newly diagnosed malignant glioma) Drug: Temozolomide (for relapsed malignant glioma) Radiation: Radiotherapy (for patients with newly diagnosed malignant glioma)
Study Arms / Comparison Groups	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
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Enrolling by invitation
Enrollment ^†	2000
Estimated Completion Date	July 2016
Estimated Primary Completion Date	July 2016 (final data collection date for primary outcome measure)
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.
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00705198
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Secondary IDs ^††
Study Sponsor ^†	Schering-Plough
Collaborators ^††
Investigators ^†
Information Provided By	Schering-Plough
Verification Date	May 2009
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.