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

Chemotherapy Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04255771
• Other study ID #: ShandongPH Urology
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 1, 2020
• Est. completion date: June 1, 2023

Study information

• Verified date: February 2020
• Source: Shandong Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Chemotherapy Effect

Intervention

Drug:
• Gemcitabine
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.
• Placebos
Use a placebo as a comparison

Locations

Country	Name	City	State
China	Shandong Provincial Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qinghua Xia,Prof

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	relapse-free survival time	Effect of postoperative adjuvant chemotherapy on relapse-free survival time	3 years
Primary	Total tumor survival time	Effect of postoperative adjuvant chemotherapy on total tumor survival time	3 years
Secondary	progression-free survival time	Effect of postoperative adjuvant chemotherapy on progression-free survival time	3 years