279
Participants
Start Date
December 31, 2010
Primary Completion Date
June 30, 2016
Study Completion Date
May 20, 2022
concurrent RAD001 10 mg/day
During radiation: RAD001 10 mg orally daily during radiation therapy; one hour prior to radiation and in the morning on weekends on days 1-42.
concurrent temozolomide
During radiation: temozolomide 75 mg/m2/day orally daily during radiation therapy; one hour prior to radiation and in the morning on weekends on days 1-42. Dose rounded to the nearest 5 mg.
Radiation therapy
Intensity Modulated RT (IMRT) allowed. For both IMRT and 3D conformal radiotherapy (3D-CRT) plans, one treatment of 2 Gy given daily 5 days per week for a total of 60 Gy over 6 weeks.
concurrent RAD001 2.5 mg/day
During radiation: RAD001 2.5 mg orally daily during radiation therapy; one hour prior to radiation and in the morning on weekends on days 1-42.
concurrent RAD001 5 mg/day
During radiation: RAD001 5 mg orally daily during radiation therapy; one hour prior to radiation and in the morning on weekends on days 1-42.
post-radiation RAD001 10 mg/day
Post-radiation: RAD001 10 mg orally daily on days 1-28 of each cycle, for up to 12 cycles, starting 28 days after the completion of radiation therapy (Cycle = 28 days).
post-radiation temozolomide
Post-radiation: temozolomide 150 mg/m2/day - 200 mg/m2/day orally daily on days 1-5 of each cycle, starting 28 days after the completion of radiation therapy for up to 12 cycles (Cycle = 28 days)
New York Oncology Hematology, PC at Albany Regional Cancer Care, Albany
University Radiation Oncology at Parkridge Hospital, Rochester
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester
Adams Cancer Center, Gettysburg
Cherry Tree Cancer Center, Hanover
York Cancer Center at Apple Hill Medical Center, York
CCOP - Christiana Care Health Services, Newark
St. Agnes Hospital Cancer Center, Baltimore
Winship Cancer Institute of Emory University, Atlanta
Integrated Community Oncology Network - Orange Park, Orange Park
Flagler Cancer Center, Saint Augustine
Florida Cancer Center - Palatka, Palatka
Baptist Cancer Institute - Jacksonville, Jacksonville
Integrated Community Oncology Network at Southside Cancer Center, Jacksonville
Integrated Community Oncology Network, Jacksonville Beach
Baptist Medical Center South, Jacksonville
Regional Cancer Center at Singing River Hospital, Pascagoula
Cleveland Clinic Taussig Cancer Center, Cleveland
Barberton Citizens Hospital, Barberton
St. Vincent Oncology Center, Indianapolis
Waukesha Memorial Hospital Regional Cancer Center, Waukesha
Medical College of Wisconsin Cancer Center, Milwaukee
Tel-Aviv Sourasky Medical Center, Tel Aviv
Tyler Cancer Center, Tyler
Huntsman Cancer Institute at University of Utah, Salt Lake City
Willamette Valley Cancer Center - Eugene, Eugene
University of Florida Shands Cancer Center, Gainesville
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa
Dana-Farber/Brigham and Women's Cancer Center, Boston
St. Barnabas Medical Center Cancer Center, Livingston
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte
Summa Center for Cancer Care at Akron City Hospital, Akron
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center, Reading
Rhode Island Hospital Comprehensive Cancer Center, Providence
University of Texas Health Science Center at San Antonio, San Antonio
Ottawa Hospital Regional Cancer Centre - General Campus, Ottawa
Collaborators (1)
National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK