A Randomized, Phase II, Double-Blind Study of Nimotuzumab Plus Whole-Brain Radiation Therapy (WBRT) Compared With WBRT Alone in Patients With Brain Metastases From Non-Small Cell Lung Cancer
A phase II, randomized, controlled, double blinded and multicenter study with 2 arms,
administering the study drug during radiotherapy and following radiotherapy until disease
progression, unacceptable toxicity or at the discretion of the physician. Randomization will
be done 2:1 (experimental:control). Chemotherapy can be added before documented disease
progression at the discretion of the physician.
The primary objective is to assess the efficacy of Nimotuzumab in combination with WBRT. The
primary endpoint is intracranial disease progression over 6 months.
The secondary endpoints are overall survival (OS); time to neurologic progression (TNP) or
death with evidence of neurologic progression; OS rate at 6 months; time to intracranial
disease progression; and time to overall progression.
Tissue samples and serum will be collected for future correlative studies.
All the images will be centrally reviewed at the end of study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Phase II: efficacy.Withhold of intracranial progression at 2, 4 and 6 months in comparison with control arm. Patients will be assessed by lab tests, MRI,neurologic examination
weekly infusions during radiotherapy and following radiotherapy until disease progression, unacceptable toxicity or withdrawal of consent.
Anthony Brade, M.D.
Assitant Professor, Department of Radiation Oncology, University of Toronto
Canada: Health Canada
|Overlake Hospital Medical Center||Bellevue, Washington 98004|
|Florida Cancer Institute - New Hope||New Port Richey, Florida 34655|
|Park Nicollet Institute - Frauenshuh Cancer Center||St. Louis Park, Minnesota 55426|