NCT04574960 Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)
| NCT ID | NCT04574960 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Health Network, Toronto |
| Condition | Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2021-02-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 14 participants in total. It began in 2021-02-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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)
Contact & Investigator
Girish Kulkarni, MD
PRINCIPAL INVESTIGATOR
University Health Network - Princess Margaret Hospital
Frequently Asked Questions
Who can join the NCT04574960 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04574960 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 14 participants.
Is NCT04574960 currently recruiting?
Yes, NCT04574960 is actively recruiting participants. Contact the research team at emily.hickey@uhn.ca for enrollment information.
Where is the NCT04574960 trial being conducted?
This trial is being conducted at Ottawa, Canada, Toronto, Canada.
Who is sponsoring the NCT04574960 clinical trial?
NCT04574960 is sponsored by University Health Network, Toronto. The principal investigator is Girish Kulkarni, MD at University Health Network - Princess Margaret Hospital. The trial plans to enroll 14 participants.
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