A Prospective Phase II Randomized Trial to Compare Intensity Modulated Proton Radiotherapy (IMPT) vs. Intensity Modulated Radiotherapy (IMRT) for Newly Diagnosed Glioblastoma (WHO Grade IV)
18 Years
N/A
Both
Brain Cancer
Trial Information
A Prospective Phase II Randomized Trial to Compare Intensity Modulated Proton Radiotherapy (IMPT) vs. Intensity Modulated Radiotherapy (IMRT) for Newly Diagnosed Glioblastoma (WHO Grade IV)
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being
assigned to either group.
If you are in Group 1, you will receive IMRT.
If you are in Group 2, you will receive IMPT.
Radiation Therapy:
In both groups, you will receive radiation treatments each day, Monday-Friday, starting on
Day 1. You will continue to receive radiation treatment until you have completed 30 total
treatments. This is a total of up to 6 weeks of treatment.
You will sign a separate consent form for the IMRT or IMPT that will explain the procedures
and risks in detail.
Study Visits:
Before beginning radiation, you will have what is called a "simulation" to plan your
radiation. During the simulation, you will be flat on your back on a computed tomography
(CT) table and a soft plastic mask will be made to help hold your head still during
treatment. This is the position you will be in when you receive radiation treatment. You
will then have a CT scan, which will make computerized images to help plan your treatment.
At Month 2 (+/- 14 days):
- You will have a physical exam, including measurement of your vital signs.
- You will have an MRI to check the status of the disease.
- You will be asked about any drugs you may be taking and side effects you may be having.
- You will complete the thinking skills tests and the questionnaires about your quality
of life and symptoms.
Length of Treatment:
You may receive up to 6 weeks of radiation therapy. You will no longer be able to receive
radiation therapy if the disease gets worse, if intolerable side effects occur, or if you
are unable to follow study directions.
Your active participation on the study will be over after the follow-up visits.
Follow-Up:
At Month 4 (+/- 14 days) and then every 2 months for up to 2 years after radiation therapy:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about any side effects you may be having.
- You will have an MRI to check the status of the disease.
- You will complete the thinking skills tests and the questionnaires about your quality
of life and symptoms.
Starting 2 years after radiation therapy, the study staff will continue checking your
medical record to find out about your health status from then on.
This is an investigational study. IMRT is delivered using FDA-approved and commercially
available methods. IMPT is investigational.
Up to 60 participants will be enrolled in this study. All will be enrolled at MD Anderson.
Inclusion Criteria:
1. All patients must have histological proof of glioblastoma (WHO Grade IV) adapted
recursive partitioning analysis (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 /=1,800 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to Cognitive Failure
Outcome Description:
Time to cognitive failure on any of 6 primary variables from pre-specified cognitive tests (HVLT-R total recall, HVLT-R delayed recall, HVLT-R delayed recognition, TMT Part A or Part B, COWA) with failure defined as a decline that meets or exceeds the reliable change index (RCI) for each cognitive test variable. A cumulative incidence approach used to estimate median time to cognitive failure in order to account for the competing risks of disease progression and death.
Outcome Time Frame:
4 months
Safety Issue:
No
Principal Investigator
Paul Brown, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
2013-0097
NCT ID:
NCT01854554
Start Date:
May 2013
Completion Date:
Related Keywords:
- Brain Cancer
- 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
- Brain Neoplasms
- Glioblastoma
Name | Location |
|---|---|
| University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |
