Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Schering-Plough |
---|---|
Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00705198 |
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.
Condition | Intervention |
---|---|
Glioma Astrocytoma |
Drug: Temozolomide (for newly diagnosed malignant glioma) Drug: Temozolomide (for relapsed malignant glioma) Radiation: Radiotherapy (for patients with newly diagnosed malignant glioma) |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
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) |
Estimated Enrollment: | 2000 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | July 2016 |
Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
Newly diagnosed patients
Patients treated with temozolomide for newly diagnosed malignant glioma
|
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.
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.
|
Relapsed patients
Patients treated with temozolomide for relapsed malignant glioma
|
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. |
Newly diagnosed anaplastic astrocytoma patients
Patients treated with temozolomide for newly diagnosed anaplastic astrocytoma
|
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.
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.
|
Patients are invited to participate in the study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P05062 |
Study First Received: | June 23, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00705198 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Neuroectodermal Tumors Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Glioma Temozolomide Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Pharmacologic Actions |