Trial intelligence / Profile preview

Intravesical Gemcitabine During Nephroureterectomy for UTUC

NCT03062059Phase 2

Key facts

Status: Unknown
Start: Mar 2018
Primary completion: Dec 2022
Countries: 1
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Modality: Small Molecules

Drugs: gemcitabine
Conditions: upper urinary tract urothelial carcinoma (UTUC)

Overview

Phase 2, randomised, open-label trial of gemcitabine in upper urinary tract urothelial carcinoma (UTUC) (2 arms), sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Primary endpoint: Two year recurrence-free survival at 2 years. Status: unknown.

Design

2 arms

Study design: RandomizedOpen-label

Gemcitabine
Intravesical 2000mg/52.6ml gemcitabine instillation during radical nephroureterectomy
Normal saline
Intravesical 52.6ml normal saline instillation during radical nephroureterectomy

Who it enrols

Patients undergoing nephroureterectomy for upper urinary tract urothelial carcinoma, aged 18-85, with normal bone marrow and liver function. Excludes patients with concomitant bladder cancer, prior bladder cancer treatment within 3 years, recent chemotherapy, or severe renal/liver dysfunction.

Endpoints

Primary

Two year recurrence-free survival2 years

Secondary

Time to recurrence6 years
Overall survival6 years
Safety of intravesical gemcitabine instillation
CT cystography finding1 week
International Prostate Symptom Score questionnaire1 week

Beyond the preview

Go deeper on NCT03062059.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT03062059.