Glioblastoma Multiforme (GBM) Proton vs. Intensity Modulated Radiotherapy (IMRT)
Condition: Brain Cancer
MeSH terms: Glioblastoma; Brain Neoplasms
Intervention: IMPT; IMRT; Cognitive Tests; Questionnaires
Intervention description: IMPT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.; IMRT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.; Cognitive tests given at baseline, 4 months, then every 2 months for 2 years.; Questionnaires about quality of life and symptoms given at baseline, 4 months, then every 2 months for 2 years.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Brain cancer; Glioblastoma; Glioblastoma Multiforme; GBM; Intensity Modulated Proton Radiotherapy; IMPT; Intensity Modulated Radiotherapy; IMRT; Radiotherapy; XRT; Cognitive tests; Thinking skills tests; Questionnaires; Surveys; Quality of life; QOL

Summary:

      The goal of this clinical research study is to compare IMRT with IMPT in patients with
      glioblastoma. Researchers want to learn about cognitive side effects (mental status changes)
      that may occur, such as memory loss and impaired thinking.

      IMRT is the delivery of focused radiation therapy using photon beams and advanced computer
      planning to help shape the dose in order to give the highest possible dose to the tumor with
      the least dose to surrounding normal tissues.

      IMPT is also focused radiation therapy similar to IMRT, but it uses proton particles to
      deliver the radiation instead of photon beams. IMPT also uses advanced computer planning in
      order to shape the dose to the target with the least dose to surrounding normal tissues.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histological diagnosis of: Glioblastoma or Gliosarcoma (WHO Grade IV) adapted RPA
             class III, IV, or V.

          2. All patients must be >/=18 years of age.

          3. All patients must sign informed consent verifying that they are aware of the
             investigational nature of this study in keeping with the rules and policies of MD
             Anderson Cancer Center. The only acceptable consent form is the one approved by MD
             Anderson IRB.

          4. All patients must have a baseline Mini Mental Status Examination score >/=21.

          5. All patients must have a KPS >/=70.

          6. All patients must be eligible to have either IMRT or IMPT as determined by the study
             radiation oncologist.

          7. All patients must be able to undergo MRI with and without contrast with a glomerular
             filtration rate (eGFR) greater than or equal to 30 mg/min/1.72 m2.

          8. All patients must have adequate liver, renal, and hematologic function within 14 days
             of registration as defined by Aspartate Amino Transferase (AST)/Alanine Amino
             Transferase (ALT)/Alkaline Phosphatase < 3 times normal, creatinine </=1.7 mg/dl, BUN
             </= 35mg/dl, absolute neutrophil count >/=1,800 cells/mm3, Hemoglobin >/= 10 g/dl, and
             platelet count > 100,000.

          9. All patients must be able to adequately read, write and speak to participate in the
             cognitive and quality of life assessments. However mild to moderate deficits in these
             functions due to tumor are allowed.

        Exclusion Criteria:

          1. Patients will be excluded if they are not planning to receive concurrent temozolomide.

          2. Patients will be excluded if they have had prior radiation to the brain.

          3. Patients will be excluded if they have had prior surgical resection of brain for other
             brain tumors.

          4. Patients will be excluded if they are pregnant as assessed by serum beta human
             chorionic gonadotropin (b-HCG). A serum b-HCG test will be performed no greater than
             14 days prior to study registration for women of childbearing potential.

          5. Patients with gliomatosis will be excluded.

          6. Patients with Gliadel bis-chloroethylnitrosourea (BCNU) implanted wafers will be
             excluded.

          7. Patients weighing greater than 136 kilograms will be excluded.