Trial Title:
Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study
NCT ID:
NCT05781321
Condition:
Glioblastoma
Conditions: Official terms:
Glioblastoma
Temozolomide
Levodopa
Fluorides
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Masking description:
The MRI scan indicating progressive disease will be fused with our treatment planning
scan and the region of progression will be contoured by an investigator blinded to the
GTV_MRI, T2_FLAIR_NCET, GTV_PET, PTV_high, and isodose lines.
Intervention:
Intervention type:
Radiation
Intervention name:
Accelerated Hypofractionated Radiation Therapy
Description:
Undergo short course RT
Arm group label:
Arm A (short course RT)
Other name:
AHF-RT
Other name:
AHRT
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT simulation
Arm group label:
Arm A (short course RT)
Arm group label:
Arm B (standard course RT)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Fluorodopa F 18
Description:
Given IV
Arm group label:
Arm A (short course RT)
Arm group label:
Arm B (standard course RT)
Other name:
(18F)FDOPA
Other name:
18F-DOPA
Other name:
18F-FDOPA
Other name:
3-(2-Fluoro-(sup 18)F-4,5-dihydroxyphenyl)-L-alanine
Other name:
6-(18F)Fluoro-L-DOPA
Other name:
Fluorine F 18 Fluorodopa
Other name:
Fluorine-18-fluoro-L-DOPA
Other name:
Fluorodopa (18F)
Other name:
FLUORODOPA F-18
Other name:
L-6-(18F)Fluoro-DOPA
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Arm A (short course RT)
Arm group label:
Arm B (standard course RT)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET
Arm group label:
Arm A (short course RT)
Arm group label:
Arm B (standard course RT)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Ancillary studies
Arm group label:
Arm A (short course RT)
Arm group label:
Arm B (standard course RT)
Other name:
Quality of Life Assessment
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Complete questionnaires
Arm group label:
Arm A (short course RT)
Arm group label:
Arm B (standard course RT)
Intervention type:
Radiation
Intervention name:
Radiation Therapy
Description:
Undergo standard course RT
Arm group label:
Arm B (standard course RT)
Other name:
Cancer Radiotherapy
Other name:
ENERGY_TYPE
Other name:
Irradiate
Other name:
Irradiated
Other name:
Irradiation
Other name:
Radiation
Other name:
Radiation Therapy, NOS
Other name:
Radiotherapeutics
Other name:
Radiotherapy
Other name:
RT
Other name:
Therapy, Radiation
Intervention type:
Drug
Intervention name:
Temozolomide
Description:
Given PO
Arm group label:
Arm A (short course RT)
Arm group label:
Arm B (standard course RT)
Other name:
CCRG-81045
Other name:
Gliotem
Other name:
Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
Other name:
M & B 39831
Other name:
M and B 39831
Other name:
Methazolastone
Other name:
RP-46161
Other name:
SCH 52365
Other name:
Temcad
Other name:
Temizole
Other name:
Temodal
Other name:
Temodar
Other name:
Temomedac
Other name:
TMZ
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Arm A (short course RT)
Arm group label:
Arm B (standard course RT)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Summary:
This phase II trial compares the effect of short course radiotherapy (RT) to standard
course RT for the treatment of patients diagnosed with glioblastoma (GBM). The
researchers want to learn whether the shorter course treatment is non-inferior (not worse
than the standard of care), for patients with GBM. Radiation therapy uses high energy
x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Short
course radiotherapy delivers higher doses of radiation over a shorter period of time and
may kill more tumor cells and have fewer side effects.
Detailed description:
PRIMARY OBJECTIVE:
I. To demonstrate non-inferior 12-month overall survival (OS) of patients with GBM
treated with dose escalated hypofractionated radiotherapy compared to standard of care.
SECONDARY OBJECTIVES:
I. To demonstrate the safety of short-course radiotherapy via physician-reported grade
(G) 3+ toxicity.
II. To explore patient-reported outcomes to demonstrate favorable quality of life with
short-course radiotherapy for GBM.
III. To analyze the impact of shortening the treatment duration on treatment related
lymphopenia and absolute lymphocyte counts.
EXPLORATORY OBJECTIVES:
I. To determine the cost-effectiveness of the 5-fraction treatment regimen compared to
standard of care.
II. To explore the impact on the immune system with the 5-fraction treatment regimen.
Immune phenotyping will be assessed by Flow Cytometry and cytometry by flight (CyTOF).
III. To analyze series of cytokine levels over time. IV. To assess patterns of failure,
specifically focusing on differences in volume delineation via Fluorodopa F 18 (FDOPA)
and magnetic resonance imaging (MRI) and recurrences in-field versus (vs.) out of field.
V. To conduct a subgroup analysis for just patients =< 65 cc. VI. To conduct a subgroup
analysis for just patients with and without tumor treating fields.
VII. To analyze patient demographic data compared to historical controls to determine
whether the short-course treatment regimen improves access to underserved populations.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo short course RT for 5-10 fractions over 1-2 weeks on study.
Patients also receive temozolomide orally (PO) on days 1-5 every 28 days during radiation
therapy. Starting one month post-radiation, patients continue temozolomide on days 1-5
every 28 days for up to 5 adjuvant cycles in the absence of disease progression or
unacceptable toxicity.
ARM B: Patients undergo standard course RT for 15-30 fractions over 3-6 weeks on study.
Patients also receive temozolomide PO daily (QD) concurrently with radiation therapy and
for up to 6 adjuvant cycles in the absence of disease progression or unacceptable
toxicity.
All patients undergo positron emission tomography/computed tomography (PET/CT) with
18-F-DOPA administered intravenously (IV) prior to RT on study, and undergo MRI prior to
RT and throughout the trial. Patients may optionally undergo blood sample collection
during screening and on the trial.
After completion of study treatment, patients are followed up every 2 months for the
first year, every 3 months for the second year, and every 4 months for the third year.
After 3 years, clinical outcomes are monitored at least once a year until 5 years after
treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age >= 18 years
- Histological and/or molecular confirmation of glioblastoma
- Eastern Oncology Group (ECOG) performance status (PS) =< 3
- Ability to complete questionnaire(s) by themselves or with assistance
- Provide written informed consent
- Willing to return to enrolling institution for follow-up either in-person or by
video visit
- Postoperative/post-biopsy tumor plus surgical bed size =< 6 cm in maximum diameter.
This measurement includes both the enhancing region identified via T1 MRI with
contrast, as well as the surgical cavity
Exclusion Criteria:
- Unable to undergo MRI scans with contrast
- Unable to undergo an 18F-DOPA-PET scan (e.g., Parkinson's Disease, taking
carbidopa/levodopa and/or less than 48 hours from discontinuance)
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate
contraception
- Tumors with IDH mutation
- Previous brain radiation therapy
- Patients who will not receive any radiation treatment or who will receive radiation
treatment elsewhere (Note: radiotherapy can be given on the trial at Mayo Clinic
facilities in Rochester, Arizona, or Florida, as well as at the Mayo Clinic Health
System sites). Temozolomide, however, can be provided by another institution
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Shelby Watkin
Phone:
480-342-6887
Investigator:
Last name:
Sujay A. Vora, MD
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224-9980
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Kayla Lane
Phone:
904-953-3588
Investigator:
Last name:
Daniel M. Trifiletti, MD
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic Health System in Albert Lea
Address:
City:
Albert Lea
Zip:
56007
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
John Yeakel, MD
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic Health Systems-Mankato
Address:
City:
Mankato
Zip:
56001
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Ron S. Smith, MD
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic Radiation Therapy - Northfield
Address:
City:
Northfield
Zip:
55057
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
James Leenstra, MD
Phone:
507-645-2655
Investigator:
Last name:
James L. Leenstra, MD
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
William G. Breen, MD
Email:
Principal Investigator
Investigator:
Last name:
Roman O. Kowalchuk, MD
Email:
Sub-Investigator
Facility:
Name:
Mayo Clinic Health System-Eau Claire
Address:
City:
Eau Claire
Zip:
54701
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Now Bahar Alam, MD
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic Health System-Franciscan Healthcare
Address:
City:
La Crosse
Zip:
54601
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Abigail L. Stockham, MD
Email:
Principal Investigator
Start date:
March 23, 2023
Completion date:
March 2, 2028
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05781321
https://www.mayo.edu/research/clinical-trials
