Chemotherapy before surgery for upper tract urothelial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.