About this trial
Upper tract urothelial cancer (UTUC) is cancer in the lining of the kidney or ureter (the tube that drains the kidney). This type of cancer is rare and as a result, there are only a few studies that have looked at it.
Standard of care for UTUC would be surgery followed by chemotherapy (adjuvant chemotherapy). However, we know from studies that have looked at cancer of the lining of the bladder, which is a similar cancer in many ways, that treating people with chemotherapy before surgery (neoadjuvant chemotherapy) can lead to longer survival compared to the standard of care. There are no studies to show this in UTUC. Neoadjuvant chemotherapy is thought to help improve survival by treating any cancer that may have spread from the original tumour but that is not visible yet on scans. This study would be the first clinical trial in Canada to evaluate the use of chemotherapy before surgery in this disease setting.
Since UTUC is rare, the purpose of this study is to determine if it is possible to enrol enough patients to a trial looking at the use of chemotherapy before surgery.
Eligibility criteria
Qualifiers
Newly diagnosed radiographically visible (CT or MRI) cT1-4 N0 M0 with positive selective urinary cytology, positive bladder urinary cytology, or endoscopic biopsy for high grade urothelial cell carcinoma
Age ≥18 years of age
Eastern Cooperative Oncology Group (ECOG) score 0-1
Medically appropriate candidate for radical nephroureterectomy or ureterectomy as per participating site attending urologic oncologist
Disqualifiers
Metastatic disease
Radiographically visible nodal disease
Concurrent muscle-invasive bladder cancer (non-muscle invasive bladder cancer is acceptable)
Solitary kidney
Trial design
Treatments tested in this trial
- Gemcitabine
- Cisplatin
- Carboplatin
Treatment groups
Sponsors and collaborators
University Health Network, Toronto
Lead sponsor
Bladder Cancer Canada
Collaborator