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

NCT02876861 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2022-11-10

No results posted yet for this study

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.

Conditions

  • High-Grade Upper Tract Urothelial Carcinoma

Interventions

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.

Sponsors & Collaborators

  • Central South University

    collaborator OTHER

  • The Third Xiangya Hospital of Central South University

    collaborator OTHER

  • Hunan Cancer Hospital

    collaborator OTHER

  • Hunan Provincial People's Hospital

    collaborator OTHER

  • Xiangya Hospital of Central South University

    lead OTHER

Principal Investigators

  • Long Wang, M.D. Ph.D. · Xiangya Hospital of Central South University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02876861 on ClinicalTrials.gov