| Titre |
Cytoreductive Stereotactic Hypofractionated Radiotherapy With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer |
| Protocole ID |
CYTOSHRINK |
| ClinicalTrials.gov ID |
NCT04090710 |
| Type(s) de cancer |
Rein |
| Phase |
Phase II |
| Stade |
Métastatique |
| Type étude |
Clinique |
| Médicament |
SBRT + Ipilimumab/Nivolumab |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Fabio Cury
|
| Coordonnateur(trice) |
Rodrigo Skowronski
514-934-1934 poste 36275
|
| Statut |
 Actif en recrutement |
| Date d'activation |
12-02-2024 |
| Critètes d'éligibilité |
- 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.
|
| Critètes d'exclusion |
- 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.
- Previous abdominal radiation precluding SBRT.
- Kanofsky Performance (KPS) score below 60 (see Appendix III).
- History of auto-immune disorder precluding treatment with ipilimumab or nivolumab.
- History of ataxia telangiectasia or other radiation sensitivity disorders.
- 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).
- Use of medicinal herbal preparations (not including medical cannabis) unless prescribed by a treating physician.
- Inability to lie flat for at least 30 minutes without moving.
- Pregnant or lactating women.
- Geographic inaccessibility for follow-up.
- Inability to provide informed consent.
|
Groupe d'étude en oncologie du Québec