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Protocol # 18-711

Status

Recruiting

Description

This randomized phase II clinical trial studies the side effects and how well proton beam or intensity-modulated radiation therapy works in preserving brain function in patients with IDH mutant grade II or III glioma. Proton beam radiation therapy uses tiny charged particles to deliver radiation directly to the tumor and may cause less damage to normal tissue. Intensity-modulated or photon beam radiation therapy uses high-energy x-ray beams shaped to treat the tumor and may also cause less damage to normal tissue. Patients will be more likely to be randomized to proton beam radiation therapy. It is not yet known if proton beam radiation therapy is more effective than photon-based beam intensity-modulated radiation therapy in treating patients with glioma.

Condition

  • 1p/19q Co-deletion
  • Anaplastic Astrocytoma
  • Diffuse Astrocytoma
  • Glioma
  • IDH1 Gene Mutation
  • IDH2 Gene Mutation
  • Oligoastrocytoma
  • Oligodendroglioma
  • WHO Grade III Glioma

Interventions

  • IMRT (Intensity-Modulated Radiation Therapy)
  • Proton Beam Radiation Therapy
  • Temozolomide

Phase

Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Change in cognition as measured by the CTB COMP score

Secondary Outcome:

  • Change in quality of life as measured by the LASA scale
  • Change in symptoms as measured by MDASI-BT
  • Cognition as measured by COWA
  • Cognition as measured by TMT parts A and B
  • Cognition as measured by HVLT-R
  • Incidence of adverse events (AEs) graded according to the National Cancer Institute's Common Terminology for Adverse Events version 4.0
  • Local control as assessed by RANO criteria
  • Overall survival (OS)
  • Progression-free survival (PFS)

Enrollment

120

Study Start Date

August 2, 2017

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

NRG Oncology

Source

NRG Oncology

Official title

A Phase II Randomized Trial of Proton Vs. Photon Therapy (IMRT) for Cognitive Preservation in Patients With IDH Mutant, Low to Intermediate Grade Gliomas

Clinicaltrials.gov Identifier

NCT03180502

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.