NRG-BN001, Photon Cohort (Group I) Closure

The photon cohort (Group I) 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 closed to accrual as of 5 PM EST Tuesday, December 20, because it has reached its accrual target, as previously broadcast on December 6, 2016.

Eligible patients registered to Group I, Step I registration by 5 PM EST Tuesday, may proceed to Group I, Step II randomization per Group I protocol timelines.

Note to sites participating in the advanced imaging sub-study: A protocol amendment is in progress for increasing the sample size to allow advanced imaging sites to continue to enroll to the photon group (Group I) in order to obtain the necessary accrual to complete the advanced MR imaging secondary aims. NRG Oncology will broadcast a reopening notification for advanced imaging sites once we receive full CTEP approval of this amendment.

The proton cohort (Group II) will remain open to patient accrual.

Reminder: Data collection and site IRB renewal for closed studies must continue until the study is terminated.

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

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