Back to resultsA Study of Postoperative Adjuvant Chemotherapy for Upper Urinary Urothelial Carcinoma With Lymphovascular Invasion
Primary Purpose
Chemotherapy Effect
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Gemcitabine
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapy Effect
Eligibility Criteria
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.
Sites / Locations
- Shandong Provincial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Effect of adjuvant chemotherapy on pTanyN0M0 UTUC with LVI
Effect of placebo on pTanyN0M0 UTUC with lymphatic invasion
Arm 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.
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.
Outcomes
Primary Outcome Measures
Total tumor survival time
Effect of postoperative adjuvant chemotherapy on total tumor survival time
Secondary Outcome Measures
progression-free survival time
Effect of postoperative adjuvant chemotherapy on progression-free survival time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04255771
Brief Title
A Study of Postoperative Adjuvant Chemotherapy for Upper Urinary Urothelial Carcinoma With Lymphovascular Invasion
Official Title
A Prospective Randomized Controlled Trial for Postoperative Adjuvant Chemotherapy for pTanyN0M0 Upper Urinary Urothelial Carcinoma With Lymphovascular Invasion
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Qinghua Xia,Prof
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy Effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Effect of adjuvant chemotherapy on pTanyN0M0 UTUC with LVI
Arm Type
Experimental
Arm 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.
Arm Title
Effect of placebo on pTanyN0M0 UTUC with lymphatic invasion
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Cisplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Placebo
Intervention Description
Use a placebo as a comparison
Primary Outcome Measure Information:
Title
Total tumor survival time
Description
Effect of postoperative adjuvant chemotherapy on total tumor survival time
Time Frame
3 years
Secondary Outcome Measure Information:
Title
progression-free survival time
Description
Effect of postoperative adjuvant chemotherapy on progression-free survival time
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
relapse-free survival time
Description
Effect of postoperative adjuvant chemotherapy on relapse-free survival time
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qinghua Xia, Prof
Organizational Affiliation
Shandong Provincial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinghua Xia,Prof, professor
Phone
0086053168773146
Ext
3147
Email
phsandi@126.com
12. IPD Sharing Statement
Learn more about this trial
A Study of Postoperative Adjuvant Chemotherapy for Upper Urinary Urothelial Carcinoma With Lymphovascular Invasion
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