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Recruiting NCT04574960

Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)

Phase III Interventional Bladder Cancer Bladder Urothelial Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gemcitabine, Cisplatin, Carboplatin.
Who it may be relevant to
Registry conditions: Bladder Cancer, Bladder Urothelial Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Neoadjuvant Chemotherapy in Upper Tract Urothelial Cancer: A Multicentre, Feasibility Pilot Trial

Overview

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.

Interventions

  • Drug Gemcitabine
    Gemcitabine 1000 mg/m\^2, IV infusion on days 1 and 8 of each 3-week cycle
  • Drug Cisplatin
    Cisplatin 70 mg/m\^2, IV infusion on day 1 of each 3-week cycle
  • Drug Carboplatin
    Carboplatin AUC 5-6 calculated using the Calvert formula on day 1 of each cycle

Primary outcome measures

  • 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 [Time frame: 24 months]
  • Disease-free survival (DFS) [Time frame: 36 months]
  • Rate of complete pathologic response [Time frame: 36 months]
Secondary outcome measures (3)
  • Site-specific enrolment rate [Time frame: 24 months]
  • Number of patients approached per site per month [Time frame: 24 months]
  • Number of patients randomized per site per month [Time frame: 24 months]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 2 centers
  • The Ottawa Hospital — Ottawa
  • University Health Network — Toronto

Identifiers

NCT: NCT04574960 · 20-5149

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗