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Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study

Scottsdale/Phoenix, AZ, Rochester, MN, Jacksonville, FL, Mankato, MN, Albert Lea, MN, Eau Claire, WI, La Crosse, WI

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Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to demonstrate non-inferior 12-month overall survival of patients with GlioblastomA (GBM) treated with dose escalated hypofractionated radiotherapy compared to standard of care. Also, to demonstrate the safety and favorable quality of life via physician-reported G3+ toxicitycompare if SBRT is non-inferior to standard of care on the proportion of overall survival of patients with glioblastoma 12 months after randomization.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information
Mankato, Minn.	Open for enrollment
La Crosse, Wis.	Open for enrollment
Jacksonville, Fla.	Closed for enrollment
Eau Claire, Wis.	Open for enrollment
Scottsdale/Phoenix, Ariz.	Open for enrollment
Albert Lea, Minn.	Open for enrollment

Print study details

Site IRB:
- Rochester, Minnesota: 22-006990
- Mankato, Minnesota: 22-006990
- La Crosse, Wisconsin: 22-006990
- Jacksonville, Florida: 22-006990
- Eau Claire, Wisconsin: 22-006990
- Scottsdale/Phoenix, Arizona: 22-006990
- Albert Lea, Minnesota: 22-006990
NCT ID:
NCT05781321
Sponsor Protocol Number:
GMROR2261

Retifanlimab With Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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Retifanlimab With Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This phase II trial tests how well retifanlimab with bevacizumab and hypofractionated radiotherapy, compared to bevacizumab and hypofractionated radiotherapy alone, works in treating patients with glioblastoma that has come back after a period of improvement (recurrent). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving retifanlimab with bevacizumab and hypofractionated radiotherapy may work better in treating patients with recurrent glioblastoma than bevacizumab and hypofractionated radiotherapy alone.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information
Jacksonville, Fla.	Open for enrollment
Scottsdale/Phoenix, Ariz.	Open for enrollment

Print study details

Site IRB:
- Rochester, Minnesota: 24-006996
- Jacksonville, Florida: 24-006996
- Scottsdale/Phoenix, Arizona: 24-006996
NCT ID:
NCT06160206
Sponsor Protocol Number:
ACCRU-NO-2301

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Contact us for the latest status	View complete study & contact information

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Contact us for the latest status	View complete study & contact information

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz.	Open for enrollment	View complete study & contact information
Rochester, Minn.	Closed for enrollment

Pagination Clinical studies

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Search Results 21-29 of 29 for

Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study

Retifanlimab With Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma

A Study to Evaluate Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer

A Study of the Possible Use of a New Imaging Method with Glioma Tumors

A Study to Explore if it is Possible to Successfully Obtain Optical Coherence Tomography (OCT) Imaging and Data While Patients Undergo Brain Surgery

Novel Circular Grid for Electrocorticography During Awake Craniotomy for Glioma Resection

Patient Adherence and Symptoms During Post-operative Fluid Restriction Protocol After Transsphenoidal Surgery

Image-based Mapping of Brain Tumors

A Study to Develop Liquid Biopsy for Pediatric Brain Tumor Patients

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