SBRT for Kidney Cancer
Trial Summary
What is the purpose of this trial?
This Phase II trial will evaluate progression-free survival after Stereotactic Body Radiation Therapy to oligoprogressive (1-5) lesions in metastatic renal cell carcinoma patients on any immune checkpoint inhibitor-containing regimen with last dose of systemic therapy within 3 months prior to trial enrollment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must not be on a TKI (a type of cancer medication) as part of your recent treatment, and you should not be on high-dose steroids or other immunosuppressive therapies within two weeks of starting the trial.
What data supports the effectiveness of the treatment Stereotactic Body Radiation Therapy (SBRT) for kidney cancer?
Research shows that Stereotactic Ablative Body Radiotherapy (SABR), including the use of CyberKnife, is a promising non-invasive treatment for kidney cancer. It can accurately target tumors while preserving kidney function and has been shown to be feasible and well-tolerated in clinical trials.12345
Is Stereotactic Body Radiation Therapy (SBRT) safe for treating kidney cancer?
How is the treatment SBRT for kidney cancer different from other treatments?
Research Team
Kimberly Johung, MD
Principal Investigator
Yale University
Eligibility Criteria
Adults with metastatic renal cell carcinoma currently on immune checkpoint inhibitors, who have developed 1-5 new lesions. They must not be pregnant or breastfeeding, agree to use effective birth control, and have a life expectancy over 6 months. Excluded are those with recent radiation therapy, live vaccines taken recently, certain autoimmune diseases or infections, brain-only oligoprogression, and serious conditions that preclude radiotherapy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Stereotactic Body Radiation Therapy (SBRT) is delivered to oligoprogressive lesions while continuing immune checkpoint inhibitor regimen
Follow-up
Participants are monitored for progression-free survival and overall survival with imaging every three months
Long-term monitoring
Long-term monitoring for overall survival and recurrence
Treatment Details
Interventions
- Stereotactic Body Radiation Therapy
Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada for the following indications:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor