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

Who is this study for? Patients with Glioma
What treatments are being studied? Temozolomide
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Prior to STEP 1 REGISTRATION

• Tumor tissue must be available for submission for central pathology review

• Documentation from the enrolling site confirming the presence of IDH mutation and 1p/19q status; the provided information must document assays performed in clinical laboratory improvement amendments (CLIA)-approved laboratories

• Only English speaking patients are eligible to participate as the cognitive and quality of life assessments are available only in English

• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

• Karnofsky performance status of >= 70 within 30 days prior to registration

• Absolute neutrophil count (ANC) >= 1,500 cells/mm^3

• Platelets >= 100,000 cells/mm^3

• Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable)

• Bilirubin =< 1.5 upper limit of normal (ULN)

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN

• BUN < 30 mg/dl

• Serum creatinine < 1.5 mg/dl

• Post-operative magnetic resonance (MR) imaging with contrast is mandatory obtained for radiation therapy planning; enrolling sites are highly encouraged to obtain thin-slice (<1.5 mm) 3D T1 pre and post contrast and Axial T2/FLAIR sequences for planning purposes

• Prior to STEP 2 REGISTRATION

• The following baseline neurocognitive assessments must be completed and uploaded prior to step 2 registration: HVLT-R, TMT Parts A and B, and COWA

• Completion of all items on the following baseline quality of life forms: MDASI-BT, LASA QOL, WPAI-GH and Employment Questionnaire. These quality of life forms will be required and data entered at step 2 registration.

• Financial clearance for proton therapy treatment prior to step 2 registration

• Centrally reviewed histologically proven diagnosis of supratentorial, Word Health Organization (WHO) grade II or III astrocytoma, oligodendroglioma or oligoastrocytoma, with IDH mutation

Locations
United States
Alabama
University of Alabama at Birmingham Cancer Center
Recruiting
Birmingham
Florida
Boca Raton Regional Hospital
Active, not recruiting
Boca Raton
Miami Cancer Institute
Recruiting
Miami
Georgia
Emory Proton Therapy Center
Active, not recruiting
Atlanta
Emory University Hospital Midtown
Active, not recruiting
Atlanta
Emory University Hospital/Winship Cancer Institute
Active, not recruiting
Atlanta
Illinois
Northwestern University
Recruiting
Chicago
Northwestern Medicine Cancer Center Delnor
Recruiting
Geneva
Northwestern Medicine Cancer Center Warrenville
Recruiting
Warrenville
Massachusetts
Massachusetts General Hospital Cancer Center
Recruiting
Boston
Maryland
Maryland Proton Treatment Center
Recruiting
Baltimore
University of Maryland/Greenebaum Cancer Center
Recruiting
Baltimore
UM Upper Chesapeake Medical Center
Recruiting
Bel Air
Central Maryland Radiation Oncology in Howard County
Recruiting
Columbia
UM Baltimore Washington Medical Center/Tate Cancer Center
Recruiting
Glen Burnie
Maine
Maine Medical Center- Scarborough Campus
Recruiting
Scarborough
Minnesota
Mayo Clinic in Rochester
Recruiting
Rochester
Missouri
Washington University School of Medicine
Recruiting
Saint Louis
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Active, not recruiting
New York
Ohio
Case Western Reserve University
Recruiting
Cleveland
University Hospitals Parma Medical Center
Recruiting
Parma
University Hospitals Portage Medical Center
Recruiting
Ravenna
Oklahoma
University of Oklahoma Health Sciences Center
Recruiting
Oklahoma City
Pennsylvania
University of Pennsylvania/Abramson Cancer Center
Suspended
Philadelphia
Texas
M D Anderson Cancer Center
Recruiting
Houston
Washington
FHCC at Northwest Hospital
Active, not recruiting
Seattle
University of Washington Medical Center - Montlake
Recruiting
Seattle
Time Frame
Start Date: August 2, 2017
Estimated Completion Date: January 2030
Participants
Target number of participants: 120
Treatments
Active Comparator: Arm I (photon-based IMRT, temozolomide)
Patients undergo photon-based IMRT QD, 5 days a week for 6 weeks for a total of 30 fractions. Beginning 4 weeks after completion of radiation therapy, patients receive standard of care temozolomide for 5 days. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression of unacceptable toxicity.
Experimental: Arm II (proton beam radiation therapy, temozolomide)
Patients undergo proton beam radiation therapy QD, 5 days a week for 6 weeks for a total of 30 fractions. Beginning 4 weeks after completion of radiation therapy, patients receive standard of care temozolomide for 5 days. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression of unacceptable toxicity.
Sponsors
Leads: NRG Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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