| Study name |
CYTOSHRINK |
| Methods |
Study type: RCT, parallel assignment, phase II
Blinding: no, open‐label
Accrual period: January 29, 2020 ‐ December 31, 2023
Countries: international (Australia, Canada), multicentre (7 study locations)
Cross‐over study: no
Status: Recruiting (as of March 31, 2022) |
| Participants |
Estimated enrolment: N=78
Inclusion criteria:
biopsy proven renal cell carcinoma of any histology imaging proven metastatic disease based on CT or MRI within 10 weeks of screening intermediate/poor risk disease based on IMDC criteria (see Appendix II) primary kidney lesion amenable to SBRT eligible for standard of care delivery of ipilimumab and nivolumab (I/N) according to approved product monograph all sexes, 18 years and older
Exclusion criteria:
a maximum primary renal lesion size of 20 cm or greater 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) treatment with prior systemic therapy in the adjuvant or metastatic setting for renal cell carcinoma Kanofsky Performance (KPS) score below 60 (see Appendix III) history of auto‐immune disorder precluding treatment with ipilimumab or nivolumab 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) inability to lie flat for at least 30 minutes without moving
*Other protocol‐defined inclusion/exclusion criteria apply |
| Interventions |
Experimental arm: Radiation: SBRT + ipilimumab/nivolumab
Control arm: ipilimumab/ nivolumab |
| Outcomes |
Primary outcome(s)
PFS (time frame: 2 years) The primary outcome of this study is the hazard ratio for progression‐free survival (PFS), defined from the date of randomisation until the date of progression (PFS truncated at subsequent systemic therapy) as determined by RECIST 1.1, or death due to any cause, whichever comes first
Secondary outcome(s)
Pparticipant safety (AEs/SAEs) (time frame: date of randomisation until 1 year post treatment), using NCI CTCAE v5. and incidence and attribution of deaths OS (time frame: 2 years) QoL: EORTC QLQ‐C30 questionnaire (time frame: 1 year), which will be evaluated using the EORTC QLQ‐C30 questionnaire
Relevant to this review but not reported: TFST, number of patients who discontinued treatment
Other outcomes (not relevant to this review): ORR, drug tolerability, stool microbiome, blood immune signature changes |
| Starting date |
January 29, 2020 |
| Contact information |
Ontario Clinical Oncology Group (OCOG) |
| Notes |
Funding source: Ontario Clinical Oncology Group (OCOG) |
