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

Sponsor
Qinghua Xia,Prof (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04255771
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
39
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Prospective Randomized Controlled Trial for Postoperative Adjuvant Chemotherapy for pTanyN0M0 Upper Urinary Urothelial Carcinoma With Lymphovascular Invasion
Anticipated Study Start Date :
Mar 1, 2020
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total tumor survival time [3 years]

      Effect of postoperative adjuvant chemotherapy on total tumor survival time

    Secondary Outcome Measures

    1. progression-free survival time [3 years]

      Effect of postoperative adjuvant chemotherapy on progression-free survival time

    Other Outcome Measures

    1. relapse-free survival time [3 years]

      Effect of postoperative adjuvant chemotherapy on relapse-free survival time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shandong Provincial Hospital Jinan Shandong China 250021

    Sponsors and Collaborators

    • Qinghua Xia,Prof

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qinghua Xia,Prof, Deputy Director of Urology, Shandong Provincial Hospital, Shandong Provincial Hospital
    ClinicalTrials.gov Identifier:
    NCT04255771
    Other Study ID Numbers:
    • ShandongPH Urology
    First Posted:
    Feb 5, 2020
    Last Update Posted:
    Feb 18, 2020
    Last Verified:
    Feb 1, 2020
    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
    Additional relevant MeSH terms:
    Carcinoma, Transitional Cell
    Gemcitabine
    Cisplatin

    Study Results

    No Results Posted as of Feb 18, 2020