Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-04-30

Brief Summary

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The purpose of this program is to evaluate the safety, tolerability, and efficacy of the new concomitant and sequential temozolomide regimen in newly diagnosed Glioblastoma patients in a routine care setting.

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Detailed Description

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Participant sampling method: consecutive patient sampling.

Conditions

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Glioblastoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Participants with newly diagnosed Glioblastoma multiforme who were prescribed temozolomide and radiotherapy as standard care.

Temozolomide

Intervention Type DRUG

Temozolomide will be administered orally at 75 mg/m\^2 with radiotherapy during the concomitant treatment phase. After four weeks, temozolomide will be administered at 150 mg/m\^2 to 200 mg/m\^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase.

Radiotherapy

Intervention Type RADIATION

Radiotherapy will consist of fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.

Interventions

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Temozolomide

Temozolomide will be administered orally at 75 mg/m\^2 with radiotherapy during the concomitant treatment phase. After four weeks, temozolomide will be administered at 150 mg/m\^2 to 200 mg/m\^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase.

Intervention Type DRUG

Radiotherapy

Radiotherapy will consist of fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.

Intervention Type RADIATION

Other Intervention Names

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Temodal Temodar SCH 052365 Radiation therapy Irradiation

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed Glioblastoma multiforme

Exclusion Criteria

* History of hypersensitivity to temozolomide or its components, or to dacarbazine.
* Women who are pregnant or breast-feeding.
* Patients with severe myelosuppression.

Eligible Sex

ALL

Accepts Healthy Volunteers

No