Trial details
Cytoreductive Stereotactic Hypofractionated Radiotherapy With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer
To find out more about this trial and your cancer treatment options, please speak with your doctor.
Trial short name: CYTOSHRINK
Official title: Cytoreductive Stereotactic Hypofractionated Radiotherapy With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer
Principal Investigator: Dr. Georg Bjarnason
Cancer type: Genitourinary
Cancer location: Kidney
Disease stage: Early Cancer
Trial phase: Phase 2
Intervention: Treatment: Stereotactic body radiation therapy (SBRT)
Registration #:
NCT04090710 
Contact e-mail: cancerclinicaltrials@sunnybrook.ca
Trial description:
The purpose of this study is to look at the effectiveness of stereotactic body radiation therapy (SBRT) in patients with metastatic (cancer spread to other parts) kidney cancer. Patients with intermediate/poor risk metastatic renal cell carcinoma (mRCC) who meet a certain criteria may be able to participate. There will be two groups of patients participating in this study; one group will receive the standard of care (ipilimumab and nivolumab) while the other group will receive the standard of care in addition to SBRT. Patients participating will know which group they are assigned to / treatment they are receiving but will be randomly allocated to one group or the other)
Inclusion Criteria: 1. Biopsy proven renal cell carcinoma of any histology. 2. Imaging proven metastatic disease based on CT or MRI within 10 weeks of screening. 3. Intermediate/poor risk disease based on IMDC criteria (see Appendix II). 4. Primary kidney lesion amenable to SBRT. 5. Eligible for standard of care delivery of ipilimumab and nivolumab (I/N) according to approved product monograph. Exclusion Criteria: 1. A maximum primary renal lesion size of 20 cm or greater. 2. Candidate for cytoreductive nephrectomy, unless a patient has refused cytoreductive nephrectomy (in this case, a discussion of cytoreductive nephrectomy and patient refusal must be documented). 3. Treatment with prior systemic therapy in the adjuvant or metastatic setting for renal cell carcinoma. 4. Previous abdominal radiation precluding SBRT. 5. Kanofsky Performance (KPS) score below 60 (see Appendix III). 6. History of auto-immune disorder precluding treatment with ipilimumab or nivolumab. 7. History of ataxia telangiectasia or other radiation sensitivity disorders. 8. Chronic corticosteroid use or other chronic immune suppressive therapy. (Participants are permitted the use of topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Adrenal replacement steroid doses of prednisone ≤ 10 mg daily are permitted). 9. Use of medicinal herbal preparations (not including medical cannabis) unless prescribed by a treating physician. 10. Inability to lie flat for at least 30 minutes without moving. 11. Pregnant or lactating women. 12. Geographic inaccessibility for follow-up. 13. Inability to provide informed consent.
