Phase 3 Bladder Cancer Trial, Recruiting NCT04574960 Sponsor: University Health Network, Toronto Condition: Bladder Cancer
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Phase 3 Bladder Cancer Trial, Recruiting

NCT04574960
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been newly diagnosed with a specific type of kidney/urinary tract cancer (high-grade urothelial carcinoma) that has been confirmed by a scan, urine test, or biopsy, and has not spread to lymph nodes or other parts of the body
  • You are 18 years of age or older
  • You are generally active and able to carry out daily activities with little or no limitation (confirm with trial site)
  • Your doctors have decided that surgery to remove the kidney and ureter (or ureter alone) is a suitable option for you
  • Your doctors have decided that a chemotherapy treatment containing cisplatin is a suitable option for you
  • Your blood counts, liver function, electrolyte levels, and kidney function are all within acceptable ranges as determined by blood tests (confirm with trial site)

Who may not be able to join:

  • Your cancer has already spread to other parts of the body (metastatic disease)
  • Scans show cancer has spread to your lymph nodes
  • You also have muscle-invasive bladder cancer at the same time (having non-muscle-invasive bladder cancer is acceptable)
  • You only have one kidney
  • You have been diagnosed with another cancer, or received systemic chemotherapy, within the last 2 years (previous bladder cancer or certain bladder treatments are still acceptable)
  • You have certain existing health conditions that make cisplatin chemotherapy unsafe for you, such as significant hearing loss, moderate-to-severe nerve damage, or a serious active infection
  • You are currently taking part in another clinical drug trial
  • You are pregnant or breastfeeding — and if you join, you must use contraception, avoid fathering a child, and not donate sperm during treatment and for 6 months after the last dose

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Girish Kulkarni, MD, University Health Network - Princess Margaret Hospital

Phone: (416) 270-5395

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
8 February 2021
Est. completion
1 December 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Feasibility of enrolling cT1-4N0 M0 UTUC patients in a randomized trial of neoadjuvant chemotherapy versus standard of care by assessing pilot trial recruitment rates; Disease-free survival (DFS); Rate of complete pathologic response

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov