Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Oct 2, 2020

Keywords

ClinConnect Summary

The NAUTICAL trial is a research study looking at a new way to treat upper tract urothelial cancer (UTUC), a rare type of bladder cancer that affects the lining of the kidney or ureter. In this trial, researchers want to find out if giving chemotherapy before surgery, instead of the usual approach of giving it afterward, can help patients live longer and improve their chances of recovery. This study is particularly important because there have been no previous trials in Canada that have investigated this method for UTUC.

To take part in the trial, participants need to be at least 18 years old and newly diagnosed with UTUC that can be seen on imaging tests like a CT or MRI scan. They should also be healthy enough to undergo surgery and chemotherapy. Throughout the trial, participants will receive treatment and be closely monitored by healthcare professionals. It’s crucial to note that participants should not have other serious health issues or other cancers that could affect their treatment. This study aims to gather enough patients to determine whether this new approach is effective and safe for those with this rare cancer.

Gender

ALL

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)