Chemotherapy before surgery for upper tract urothelial cancer
Neoadjuvant Chemotherapy in Upper Tract Urothelial Cancer: A Multicentre, Feasibility Pilot Trial
This study is testing if giving chemotherapy before surgery helps people with upper tract urothelial cancer live longer compared to the usual treatment of surgery followed by chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Ottawa, Ontario and 1 other locations) |
| Trial ID | NCT04574960 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of neoadjuvant chemotherapy using Gemcitabine and Cisplatin or Carboplatin in patients with upper tract urothelial cancer (UTUC) before undergoing surgery. The study aims to determine if administering chemotherapy prior to surgery can improve survival rates compared to the standard approach of surgery followed by adjuvant chemotherapy. It is the first clinical trial in Canada focused on this rare cancer type, which affects the lining of the kidney or ureter. Participants will be closely monitored for their response to treatment and suitability for subsequent surgery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed, radiographically visible upper tract urothelial carcinoma who are medically fit for surgery and chemotherapy.
Not a fit: Patients with non-visible cancer or those not suitable for cisplatin-based chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates for patients with upper tract urothelial cancer.
How similar studies have performed: While there have been successful studies on neoadjuvant chemotherapy for bladder cancer, this specific approach for upper tract urothelial cancer is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Medically appropriate candidate for cisplatin-based chemotherapy as per participating site attending medical oncologist * Adequate organ system function defined as follows: absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,00/mm3, hemoglobin ≥ 90 g/L, ALT and AST \< 2.5 x upper limit of normal, electrolytes (Na, K, Mg, Ca): within normal limits, GFR ≥ 60 mL/min Patients who are randomized to the adjuvant chemotherapy will be reassessed for suitability to receive adjuvant chemotherapy after definitive surgery (nephroureterectomy or ureterectomy) based on the following criteria: * pT2-4 N0-3 M0 or pT any N1-3 M0 with predominant urothelial component * ECOG score 0-2 * Medically appropriate candidate for platin-based chemotherapy as per participating site attending medical oncologist * Adequate organ system function defined as follows: absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,00/mm3, hemoglobin ≥ 90 g/L, ALT and AST \< 2.5 x upper limit of normal, electrolytes (Na, K, Mg, Ca): within normal limits, GFR ≥ 30 mL/min Exclusion Criteria: * Metastatic disease * Radiographically visible nodal disease * Concurrent muscle-invasive bladder cancer (non-muscle invasive bladder cancer is acceptable) * Solitary kidney * Other cancer diagnosis or systemic chemotherapy use within 2 years of study enrollment (prior bladder cancer and intravesical therapy allowed) * Concomitant diseases that are a formal exclusion to cisplatin chemotherapy (deafness, ≥ grade II neuropathy, serious active infection) * Concomitant use of any other investigational drugs * Pregnancy or breast feeding (you must remain on contraception, not father a child or donate sperm while receiving gemcitabine/cisplatin and for 6 months following the last dose)
Where this trial is running
Ottawa, Ontario and 1 other locations
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
- University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Girish Kulkarni, MD — University Health Network - Princess Margaret Hospital
- Study coordinator: Emily Hickey
- Email: emily.hickey@uhn.ca
- Phone: (416) 270-5395
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.