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New treatment option for Bladder Cancer
Official title Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)
ClinicalTrials.gov ID: NCT04574960
What this study is testing
What is Gemcitabine?
Gemcitabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bladder cancer.
Also referred to as Gemzar.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Newly diagnosed radiographically visible (CT or MRI) cT1-4 N0 M0 with positive selective urinary cytology, positive bladder urinary cytology, or...
- 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
You likely can't join if
- 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)
See the full eligibility 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.