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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chemotherapy Effect

Intervention / Treatment
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* Drug: Gemcitabine
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 20-85 years; ECOG score 0-1 points; Patients with UTUC, undergoing radical nephrectomy, pathological staging For pTanyN0M0; Patients voluntarily signed informed consent. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Effect of adjuvant chemotherapy on pTanyN0M0 UTUC with LVI<br>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<br>* 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.<br>* Other names: Cisplatin;|
| Placebo Comparator: Effect of placebo on pTanyN0M0 UTUC with lymphatic invasion<br>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<br>* Use a placebo as a comparison<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total tumor survival time | Effect of postoperative adjuvant chemotherapy on total tumor survival time | 3 years | 

Secondary Outcome Measures

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