Purpose

This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT or proton beam radiation therapy is more effective than standard-dose radiation therapy with temozolomide in treating glioblastoma.

Category

IRB Number
20150563HU
NCT Number
NCT02179086
Open to Enrollment
Yes
Sponsor
NRG Oncology -



Study Contact

Principal Investigator
Andrew Brenner

Andrew Brenner
(210) 562-4091
brennera@uthscsa.edu

Carol Jenkins
(210) 450-1727
jenkinsca@uthscsa.edu



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 2
      Study Type
      Interventional
      Allocation
      Randomized
      Intervention Model
      Parallel Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Adult Giant Cell Glioblastoma
    2. Adult Glioblastoma
    3. Adult Gliosarcoma

      4. Arm Groups

      ArmDescriptionIntervention
      Active Comparator

      Arm A1 (control)

      		Patients undergo standard-dose photon irradiation using 3D-CRT or IMRT QD, 5 days a week for 23 fractions plus a boost of 7 additional fractions. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
    4. Radiation: intensity-modulated radiation therapy

      Undergo standard-dose IMRT

      Other names:

      • IMRT

    5. Drug: temozolomide

      Given PO

      Other names:

      • SCH 52365
      • Temodal
      • Temodar
      • TMZ

    6. Radiation: 3-dimensional conformal radiation therapy

      Undergo standard-dose 3D-CRT

      Other names:

      • 3D conformal radiation therapy
      • 3D-CRT

    7. Other: laboratory biomarker analysis

      Correlative studies

      8. Active Comparator

      Arm A2 (control)

      		Patients undergo standard-dose photon irradiation using 3D-CRT or IMRT as in Arm A1. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
    8. Radiation: intensity-modulated radiation therapy

      Undergo standard-dose IMRT

      Other names:

      • IMRT

    9. Drug: temozolomide

      Given PO

      Other names:

      • SCH 52365
      • Temodal
      • Temodar
      • TMZ

    10. Radiation: 3-dimensional conformal radiation therapy

      Undergo standard-dose 3D-CRT

      Other names:

      • 3D conformal radiation therapy
      • 3D-CRT

    11. Other: laboratory biomarker analysis

      Correlative studies

      12. Experimental

      Arm B (photon IMRT)

      		Patients undergo dose-escalated and -intensified photon IMRT QD, 5 days a week for a total of 30 fractions. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
    12. Radiation: intensity-modulated radiation therapy

      Undergo dose-escalated and -intensified photon IMRT

      Other names:

      • IMRT

    13. Drug: temozolomide

      Given PO

      Other names:

      • SCH 52365
      • Temodal
      • Temodar
      • TMZ

    14. Radiation: photon beam radiation therapy

      Undergo dose-escalated and -intensified photon IMRT

    15. Other: laboratory biomarker analysis

      Correlative studies

      16. Experimental

      Arm C (proton beam radiation therapy)

      		Patients undergo dose-escalated and -intensified proton beam therapy QD, 5 days a week for a total of 30 fractions. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
    16. Drug: temozolomide

      Given PO

      Other names:

      • SCH 52365
      • Temodal
      • Temodar
      • TMZ

    17. Radiation: proton beam radiation therapy

      Undergo dose-escalated and -intensified proton beam radiation therapy

    18. Other: laboratory biomarker analysis

      Correlative studies

      19.