Randomized, Phase II, Double-Blind, Placebo-Controlled Trial of Conventional
Chemoradiation and Adjuvant Temozolomide Plus Cediranib Versus
Conventional Chemoradiation and Adjuvant Temozolomide Plus Placebo
in Patients With Newly Diagnosed Glioblastoma
Protocol-RTOG 0837/ACRIN 6689 Amendments 3 and 4, 3.7.11 [PDF]
SOC-RTOG 0837/ACRIN 6689 Amendment 3 and 4, 3.7.11 [PDF]
Informed Consent-RTOG 0837/ACRIN 6689 [DOC]
RTOG Principal Investigator: Tracy Batchelor, MD
ACRIN Principal Investigator: A. Gregory Sorensen, MD
Status: ACRIN 6689 Component Closed
Overview: ACRIN 6689 is the advanced-imaging component of the RTOG 0837
trial. Pre-qualification of MRI and PET scanners and images is required at RTOG sites
wishing to participate in the advanced-imaging component. All eligible participants
recruited at advanced-imaging sites must be consented to advanced imaging.
The advanced-imaging component comprises seven (7) DSC- and DCE-MRI scans
[three (3) of these MRI scans are optional with approval of Amendments 3 and 4
to the protocol] and four (4) FLT PET scans using this investigational imaging agent.
See the protocol for specifics on timing for these scans. Pre-MRI blood collection and
peri-PET blood sampling with same-day processing are required.
Main Objectives: The main objective of the ACRIN 6689 trial is to assess
the association between overall survival and change in imaging biomarkers (Ktrans,
gradient echo CBV, and [18F]FLT Ki and K1) from baseline imaging to imaging between
doses of cediranib or placebo. Additional aims will assess progression-free survival and
overall survival between these and other imaging time points, reproducibility of FLT PET
imaging, relationships between FLT PET imaging biomarkers and tumor proliferation, and
the "vascular normalization index".
Participants: People with newly diagnosed, histopathologically-confirmed
glioblastoma (WHO Grade IV) able to undergo MRI and PET who are accrued to ACRIN-
qualified, RTOG sites participating in the ACRIN 6689 advanced-imaging component.
Study Design Summary: A total of 51 participants from the 177 RTOG-study
patients will be accrued to the ACRIN 6689 advanced-imaging component of the trial.
A total of 25 participants will undergo a second FLT PET scan (Baseline #2) prior to
initiation of chemotherapy; participants from each advanced-imaging site will asked to
undergo the second FLT PET scan until 25 participants have completed advanced imaging.