A Randomized Phase III Study Comparing Temporally-modulated Pulsed Radiation Therapy (TMPRT) Versus Standard Radiation Therapy with Temozolomide for Adults with Newly Diagnosed MGMT-unmethylated Glioblastoma
Study Description
This study is being done to answer the following question:
1) Will pulsed radiation therapy improve overall survival and delay the decline in thinking and
memory skills compared to standard radiation therapy in glioblastoma patients with an
unmethylated MGMT gene?
2) We are doing this study because we want to find out if this approach is better or worse than the
usual approach for your glioblastoma. The usual approach is defined as care most people get for
glioblastoma.
Eligibility
Prior to Step 1 Registration
3.2.1 No known IDH mutation. (If tested before step 1 registration, patients
known to have IDH mutation in the tumor on local or other testing are
ineligible and should not be registered).
3.2.2 Availability of FFPE tumor tissue block and H&E stained slide to be sent
for central pathology review for confirmation of histology and MGMT
promoter methylation status (See Section 10). Surgical resection is
required; stereotactic biopsy alone is not allowed because it will not
provide sufficient tissue for MGMT analysis. Note that tissue for
central pathology review and central MGMT assessment must be
shipped to the NYU Center for Biospecimen Research and
Development (CBRD) on or before postoperative calendar day 30. If
tissue cannot be shipped by postoperative calendar day 30, then
patients may NOT enroll on this trial as central pathology review will
not be complete in time for the patient to start treatment no later than 8
weeks following surgery. Results of central pathology review and
central MGMT analysis will generally be completed within 10 business
days of receipt of tissue. Results will be entered by the central lab
directly into Rave. Note: In the event of an additional tumor
resection(s), tissue must be shipped within 30 days of the most recent
resection and the latest resection must have been performed within 30
days after the initial resection.
3.2.3 Not Pregnant and Not Nursing
3.2.4 Radiographic Criteria for Eligibility
3.2.6 Proficient in English or French Canadian.
3.2.7 Karnofsky Performance Status ≥ 70
3.2.8 Required Initial Laboratory Values
3.2.9 Prior Treatment
3.2.10 Comorbid Conditions
3.2.11 Allergies
Prior to Step 2 Registration
3.2.12 Neurocognitive tests
3.2.13 Documentation of Disease
