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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chemotherapy Effect
• Intervention / Treatment: Drug: Gemcitabine; Drug: Placebos

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250021
      • Shandong Provincial Hospital
      • Contact: Qinghua Xia,Prof, professor; Phone Number: 3147 0086053168773146; Email: phsandi@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Effect of adjuvant chemotherapy on pTanyN0M0 UTUC with LVI; 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; 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.; Other Names: Cisplatin
Placebo Comparator: Effect of placebo on pTanyN0M0 UTUC with lymphatic invasion; 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; Use a placebo as a comparison; Other Names: Placebo

What is the study measuring?

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qinghua Xia,Prof
• Investigators: Study Director: Qinghua Xia, Prof, Shandong Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 15, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma, Transitional Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine; Cisplatin
• Other Study ID Numbers: ShandongPH Urology

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No