A Study of Postoperative Adjuvant Chemotherapy for Upper Urinary Urothelial Carcinoma With Lymphovascular Invasion

A Prospective Randomized Controlled Trial for Postoperative Adjuvant Chemotherapy for pTanyN0M0 Upper Urinary Urothelial Carcinoma With Lymphovascular Invasion

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04255771

Enrollment

200

Registered

2020-02-05

Start date

2020-03-01

Completion date

2023-06-01

Last updated

2020-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy Effect

Brief summary

Detailed description

This project is to explore the effect of adjuvant chemotherapy on total tumor survival time, progression-free survival time, and recurrence-free survival time in patients with pTanyN0M0 upper urinary urothelial carcinoma with lymphatic vascular invasion (LVI) through a prospective case-control study. Therapeutic value of adjuvant chemotherapy for LVI(+) patients with pT1N0M0, pT2N0M0, and pT3-4N0M0 upper urinary urothelial carcinoma, respectively.

Interventions

DRUGGemcitabine

Standard GC (gemcitabine and cisplatin) regimen: gemcitabine 1000-1200mg/m2 intravenous infusion on days 1 and 8, cisplatin 70mg/m2 on the second day of intravenous infusion, every 3 weeks (21-day regimen) is a cycle, A total of 3 cycles.

DRUGPlacebos

Use a placebo as a comparison

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

Inclusion criteria

1. Aged 20-85 years; 2. ECOG score 0-1 points; 3. Patients with UTUC, undergoing radical nephrectomy, pathological staging For pTanyN0M0; 4. Patients voluntarily signed informed consent.

Exclusion criteria

1. Obvious cardiopulmonary dysfunction, serious diabetes and other chronic diseases; 2. Obvious chemotherapy contraindications; 3. Patients have a history of other organ malignancies; 4. Combined with tumors of other sites.

Design outcomes

Primary

Measure	Time frame	Description
Total tumor survival time	3 years	Effect of postoperative adjuvant chemotherapy on total tumor survival time

Secondary

Measure	Time frame	Description
progression-free survival time	3 years	Effect of postoperative adjuvant chemotherapy on progression-free survival time

Other

Measure	Time frame	Description
relapse-free survival time	3 years	Effect of postoperative adjuvant chemotherapy on relapse-free survival time

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026