eo-adjuvant versus Adjuvant chemotherapy in Upper Tract Urothelial Carcinoma: A feasibility phase II randomized clinical trial (*URANUS*)

Phase 2

Recruiting

• Conditions: 10038364; 10018188; cancer in urinary upper tract; urethelial carcinoma

• Registration Number: NL-OMON48801
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

Histological and radiological defined UTUC: Histologically-confirmed diagnosis
of predominantly urothelial carcinoma of the upper urinary tract
Patients with UTUC cT2-cT4 cN0-N1 M0 (TNM classification)
Patients without bladder cancer or with concomitant non muscle invasive bladder
cancer.
Adequate organ system function
CT scan of the chest, abdomen and pelvis and bone scan without evidence of
distant metastasis

Exclusion Criteria

Histology of pure adenocarcinoma, pure squamous cell carcinoma, sarcomatoid or
predominant small cell carcinoma.
Any major contraindication to a surgical procedure.
Other active neoplasms.
Concomitant muscle invasive bladder cancer.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of UTUC patients with adequate renal function that were able to<br /><br>receive either neo- or adjuvant cisplatin-based chemotherapy treatment<br /><br>Proportion of UTUC patients randomized to neo- or adjuvant chemotherapy that<br /><br>were able to start and finalize three courses of planned chemotherapy<br /><br>Actually delivered dose vesus planned dose of chemotherapy administered in<br /><br>patients randomized to neo- or adjuvant chemotherapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1- and 2-year Disease Free Survival (DFS), Overall Survival (OS) and<br /><br>Cancer-Specific Survival (CSS)<br /><br>Safety and tolerability of neo-adjuvant versus adjuvant chemotherapy<br /><br>Evaluate histopathology in each group and histological response in the<br /><br>neo-adjuvant patient group</p><br>