Spots Global Cancer Trial Database for A Study of Nimotuzumab in Combination With Radiation Therapy in Patients With Brain Metastases
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Trial Identification
Brief Title: A Study of Nimotuzumab in Combination With Radiation Therapy in Patients With Brain Metastases
Official Title: 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
Study ID: NCT00872482
Conditions
Interventions
Study Description
Brief Summary: This is a randomized, Phase II study designed to investigate Nimotuzumab plus whole-brain radiation therapy (WBRT)and to compare it rith WBRT alone in patients with brain metastases from non-small cell lung cancer (NSCLC). The purpose of the study is to assess the efficacy of nimotuzumab in combination with WBRT.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Florida Cancer Institute - New Hope, New Port Richey, Florida, United States
Park Nicollet Institute - Frauenshuh Cancer Center, St. Louis Park, Minnesota, United States
Overlake Hospital Medical Center, Bellevue, Washington, United States
Tom Baker Cancer Center, Calgary, Alberta, Canada
Cancer Centre for the Southern Interior, Kelowna, British Columbia, Canada
Dr. H. Bliss Murphy Cancer Centre, St. John's, Newfoundland and Labrador, Canada
Royal Victoria Hospital, Barrie, Ontario, Canada
London Regional Cancer Center, London, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada
Hotel Dieu Hospital, Quebec City, Quebec, Canada
Hospital Clínico Quirúrgico Hermanos Ameijeiras, Centro Habana, La Habana, Cuba
Severance Hospital, Seoul, , Korea, Republic of
Hameed Latif Hospital, Lahore (HLH), Town, Lahore, Pakistan
Nuclear Medicine and Radiation Oncology Institute (NORI), Islamabad, , Pakistan
Contact Details
Name: Anthony Brade, M.D.
Affiliation: Assitant Professor, Department of Radiation Oncology, University of Toronto
Role: PRINCIPAL_INVESTIGATOR
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