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NRG-BN001

Trial

Clinical Trial Title

NRG-BN001

Trial Status

Open to Enrollment

Start Date

July 24, 2017

Location

Trial Type

Cancer (Oncology)

Specific Condition

Glioblastoma

Description

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

Eligibility Criteria

  • Histologically proven diagnosis of glioblastoma (WHO grade IV) confirmed by central review prior to step 2 registration
  •     Diagnosis must be made by surgical excision, either partial or complete. Stereotactic biopsy and cavitronic ultrasonic surgical (CUSA) techniques are not allowed
  • Age ≥ 18
  • Karnofsky performance status ≥ 70 within 28 days
  • Tumor tissue that is determined by central pathology review
  • History/physical examination within 28 days
  • The patient must have recovered from effects of surgery, postoperative infection, and other complications within 28 days
  • Documentation of steroid doses within 28 days
      
Ineligibility Criteria
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years
  • Recurrent or multifocal malignant gliomas
  • Any site of distant disease
  • Prior chemotherapy or radiosensitizers for cancers of the head and neck region
  • Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted
  • Prior radiotherapy to the head or neck

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Andrew Kee, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Thursday, December 28, 2017 11:31:24 AM