Adaptive Radiotherapy for Brain Tumor
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to find out if performing additional Magnetic Resonance Image (MRI) scans of the subjects' brain during each week of the radiation treatment of their high-grade glioma will help improve the radiation treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is sacituzumab govitecan safe for humans?
Sacituzumab govitecan has been studied in various cancers and generally shows a safe profile, but it can cause side effects like neutropenia (low white blood cell count), diarrhea, and fatigue. It's important to monitor for serious reactions such as colitis (inflammation of the colon) and sepsis (a severe infection) during treatment.12345
How is adaptive radiotherapy different from other treatments for brain tumors?
Adaptive radiotherapy (ART) is unique because it adjusts the treatment plan based on changes in the tumor size and position during the treatment period, which can increase precision and reduce damage to healthy tissues. This approach is different from traditional radiotherapy, which uses a fixed plan throughout the treatment.678910
What data supports the effectiveness of the drug sacituzumab govitecan for treating brain tumors?
Sacituzumab govitecan has shown effectiveness in treating various solid tumors, including breast cancer and small cell lung cancer, by targeting a protein called Trop-2 on cancer cells. It has been approved for use in metastatic triple-negative breast cancer and is being explored for other cancers, including brain metastases.2351112
Who Is on the Research Team?
Tony J. Wang, MD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
This trial is for adults over 18 with high-grade gliomas like glioblastoma, who haven't had previous tumor treatments except biopsy or resection. They must have a Karnofsky performance status of 70+ and plan to receive standard radiotherapy. Pregnant women can't participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation Treatment
Participants receive radiotherapy per standard of care over 30-33 once-daily fractions with 7 brain MRIs each week, or 15 once-daily fractions with 4 brain MRIs each week for those receiving hypofractionated radiotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Adaptive Radiotherapy
Adaptive Radiotherapy is already approved in United States, European Union, Canada for the following indications:
- Metastatic triple-negative breast cancer (mTNBC)
- Metastatic hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer
- Metastatic urothelial cancer (approval being withdrawn)
- Metastatic triple-negative breast cancer (mTNBC)
- Metastatic urothelial cancer
- Metastatic triple-negative breast cancer (mTNBC)
- Metastatic urothelial cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
Varian Medical Systems
Industry Sponsor
Dow R. Wilson
Varian Medical Systems
Chief Executive Officer since 2012
MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University
Dr. Deepak Khuntia
Varian Medical Systems
Chief Medical Officer since 2020
MD from the University of Cambridge, PhD from the University of Leicester