NCT02876861

Neoadjuvant Chemotherapy Versus Surgery Alone in Patients With High-Grade UTUC

Neoadjuvant Chemotherapy Versus Surgery Alone in Patients With High-Grade Upper Tract Urothelial Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin (GC) for 2-4 cycles can help shrink the tumor before undergoing surgery and improves the overall survival for high-grade upper tract urothelial carcinoma.

Detailed description

The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin (Gemcitabine, 1250mg/m2, d1 d8, Cisplatin, 75mg/m2, d1-d3, 21d, 2-4 cycles) for 2-4 cycles can help shrink the tumor before undergoing surgery and improves the overall survival for high-grade upper tract urothelial carcinoma.

Conditions

• High-Grade Upper Tract Urothelial Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Radical nephroureterectomy	Radical nephroureterectomy (RNU) with an ipsilateral bladder cuff
PROCEDURE	Distal ureterectomy	Distal ureterectomy.
DRUG	Neoadjuvant Chemotherapy	Gemcitabine, 1250mg/m2, d1 d8, Cisplatin, 75mg/m2, d1-d3, 21d, 2-4 cycles.

Timeline

• Start date: 2014-02-01
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2016-08-24
• Last updated: 2022-11-10

Locations

1 site across 1 country: China