PROTOCOL NRG-BN001:

Temporary closure notice to the advanced imaging sub-study for patients enrolling to Group II: Proton Cohort 

Accrual to the advanced imaging sub-study for patients enrolling to the Proton Cohort (Group II) of NRG-BN001, “Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation with Concomitant and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma,” is temporarily closed to accrual effective immediately, while evaluability of enrolled patients is being assessed to determine whether the required sub-study sample size has been met.

If the assessment determines that enough evaluable patients have been enrolled to obtain the required sub-study sample size, the sub-study will be permanently closed to accrual. If the assessment determines that additional patients are needed, the sub-study will be reopened to accrual to obtain the required sample size. NRG Oncology will issue a broadcast when a reopening decision is made.

As broadcast on July 20, 2018, the advanced imaging sub-study for the Photon Cohort (Group I) is permanently closed to accrual.

For questions about the advanced imaging sub-study, please contact Christina Tsien, MD, ctsien@radonc.wustl.edu.

Please distribute this information to the appropriate personnel at participating affiliate/NCORP component institutions.

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