Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy - Observational Program (Study P04816)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Glioblastoma

Treatments: Radiation: Radiotherapy; Drug: Temozolomide

Study type: Observational

Funder types: Industry

Identifiers

NCT00725010

P04816

Details and patient eligibility

About

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.

Full description

Participant sampling method: consecutive patient sampling.

Enrollment: 64 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

64 participants in 1 patient group

Patients

Description:

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

Treatment:

Radiation: Radiotherapy

Drug: Temozolomide