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

NCT04255771 | Unknown Phase 3 DMC

• 1 other identifier: ShandongPH Urology
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• Total tumor survival time

  Effect of postoperative adjuvant chemotherapy on total tumor survival time

  3 years

Secondary Outcomes (1)

• progression-free survival time

  3 years

Other Outcomes (1)

• relapse-free survival time

  3 years

Study Arms (2)

Effect of adjuvant chemotherapy on pTanyN0M0 UTUC with LVI

EXPERIMENTAL

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.

Drug: Gemcitabine

Effect of placebo on pTanyN0M0 UTUC with lymphatic invasion

PLACEBO COMPARATOR

As a control, this clinical trial also set up a placebo control group. The effect of adjuvant chemotherapy was obtained by random grouping and comparing the effects of patients in the experimental group and the control group.

Drug: Placebos

Interventions

Gemcitabine DRUG

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.

Also known as: Cisplatin

Effect of adjuvant chemotherapy on pTanyN0M0 UTUC with LVI

Placebos DRUG

Use a placebo as a comparison

Also known as: Placebo

Effect of placebo on pTanyN0M0 UTUC with lymphatic invasion

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Qinghua Xia,Prof: lead

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

MeSH Terms

Interventions

Gemcitabine; Cisplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Qinghua Xia, Prof

  Shandong Provincial Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director of Urology, Shandong Provincial Hospital

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: February 5, 2020
• Study Start: March 1, 2020
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 18, 2020

Record last verified: 2020-02

Locations

CN (1)