NCT04574960RecruitingPhase 3
Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)
Neoadjuvant Chemotherapy in Upper Tract Urothelial Cancer: A Multicentre, Feasibility Pilot Trial
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 18 Sept 2020
- Start date
- 8 Feb 2021
- Primary completion date
- Dec 2027
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Bladder cancer
- NCT number
- NCT04574960
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 14
- From 8 Feb 2021 to the primary completion date, Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent muscle-invasive bladder cancer (non-muscle invasive bladder cancer is acceptable)
- 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)
Other illness
- Metastatic disease
- Radiographically visible nodal disease
Other
- Solitary kidney
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.