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

CompletedOBSERVATIONAL
Enrollment

64

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

April 30, 2009

Study Completion Date

April 30, 2009

Conditions
Glioblastoma
Interventions
DRUG

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.

RADIATION

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.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00725010 - Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy - Observational Program (Study P04816) | Biotech Hunter | Biotech Hunter