RecruitingPhase 3NCT04574960

Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)

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

Sponsor

University Health Network, Toronto

Enrollment

14 participants

Start Date

Feb 8, 2021

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer Bladder Urothelial Carcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether giving chemotherapy before surgery (neoadjuvant) is better than after surgery (adjuvant) for people with invasive cancer of the kidney's collecting system (upper tract urothelial carcinoma). Participants will be randomly assigned to one of these two approaches. **You may be eligible if...** - You are 18 years old or older - You have newly diagnosed, invasive urothelial cancer of the upper urinary tract (kidney or ureter) - Your cancer has not spread to lymph nodes or other organs - You are in good general health (ECOG 0–1) - Your kidneys and blood counts are healthy enough for cisplatin-based chemotherapy - You are a candidate for surgery to remove the kidney and ureter **You may NOT be eligible if...** - Your cancer has spread (metastatic) - You have muscle-invasive bladder cancer at the same time - You have only one kidney - You have had another cancer or chemotherapy in the past 2 years - You have significant hearing loss, nerve damage, or other conditions preventing cisplatin use Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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