Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent
Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus
Conventional Concurrent Chemoradiation and Adjuvant Temozolomide
in Patients With Newly Diagnosed Glioblastoma 

Protocol Documents

Protocol-RTOG 0825/ACRIN 6686 Amendment 4, 11.29.10 [PDF]

SOC-RTOG 0825/ACRIN 6686 Amendment 4, 11.29.10 [PDF]

Informed Consent-RTOG 0825/ACRIN 6686 [DOC]

RTOG Principal Investigator:  Mark R. Gilbert, MD

ACRIN Principal Investigator:  Jerold Boxerman, MD

Status:  Accrual Completed

Overview: ACRIN 6686 is the advanced-imaging component of the RTOG 0825 
trial. Pre-qualification of imaging scanners and images is required at RTOG sites 
wishing to participate in the advanced-imaging component. All eligible potential 
participants recruited at advanced-imaging sites must be asked to consent to 
advanced imaging. The advanced-imaging component comprises four (4) DSC- 
and DCE-MRI scans at baseline (T0), Week 3 (T1), Week 3 1 Day (T2), and 
Week 10 (T3).

Main Objectives: The main objectives of the ACRIN 6686 trial are to assess 
the association between overall survival and Ktrans change from T1 to T2 and 
to assess the association between overall survival and spin echo CBV changes 
from T1 to T2.

Participants: People with newly diagnosed, histopathologically-confirmed 
glioblastoma (WHO Grade IV) able to undergo MRI who are accrued to ACRIN-
qualified, RTOG sites participating in the ACRIN 6686 advanced-imaging component.

Study Design Summary: A total of 264 participants from the 720 RTOG-study 
patients will be accrued to the ACRIN 6686 advanced-imaging component of the trial.