35
Participants
Start Date
March 8, 2005
Primary Completion Date
January 16, 2008
Study Completion Date
January 16, 2008
Temozolomide and radiotherapy
Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100 mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
Whole brain radiotherapy
2 regimens are allowed: a) 20 fractions of 2 Gray each, administered on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
Collaborators (1)
AESCA Pharma GmbH
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY