Health TrialsbyHealthPanel

Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)

ConditionsBladder CancerBladder Urothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Metastatic disease

Radiographically visible nodal disease

Concurrent muscle-invasive bladder cancer (non-muscle invasive bladder cancer is acceptable)

Solitary kidney

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gemcitabine

    Drug

    Gemcitabine 1000 mg/m\^2, IV infusion on days 1 and 8 of each 3-week cycle

  • Cisplatin

    Drug

    Cisplatin 70 mg/m\^2, IV infusion on day 1 of each 3-week cycle

  • Carboplatin

    Drug

    Carboplatin AUC 5-6 calculated using the Calvert formula on day 1 of each cycle

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: Neoadjuvant Chemotherapy ArmExperimental treatment 2 interventions
Group B: Adjuvant Chemotherapy Arm (Standard of Care)Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

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
2

Disease-free survival (DFS)

DFS is defined as the time from randomization to development of intravesical recurrence, contralateral upper tract recurrence or distant metastasis

Time frame
36 months
3

Rate of complete pathologic response

Complete pathologic response is defined as pT0 N0

Time frame
36 months

Secondary outcomes

1

Site-specific enrolment rate

Time frame
24 months
2

Number of patients approached per site per month

Time frame
24 months
3

Number of patients randomized per site per month

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Bladder Cancer Canada

Collaborator

Source ClinicalTrials.gov
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