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

Phase 3

• Conditions: Chemotherapy Effect
• Interventions: Drug: Placebos; Drug: Gemcitabine

• Registration Number: NCT04255771
• Lead Sponsor: Qinghua Xia,Prof

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-21
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-05
• Last Update Submitted: 2020-02-15
• Last Update Posted: 2020-02-18
• Study Start: 2020-03-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Effect of placebo on pTanyN0M0 UTUC with lymphatic invasion	Placebos	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.
Effect of adjuvant chemotherapy on pTanyN0M0 UTUC with LVI	Gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
Total tumor survival time	3 years	Effect of postoperative adjuvant chemotherapy on total tumor survival time

Secondary Outcome Measures

Name	Time	Method
progression-free survival time	3 years	Effect of postoperative adjuvant chemotherapy on progression-free survival time

Trial Locations

Locations (1)

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China