A Study of Postoperative Adjuvant Chemotherapy for Upper Urinary Urothelial Carcinoma With Lymphovascular Invasion
NCT ID: NCT04255771
Last Updated: 2020-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2020-03-01
2023-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
Placebos
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Interventions
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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.
Placebos
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Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Obvious chemotherapy contraindications;
3. Patients have a history of other organ malignancies;
4. Combined with tumors of other sites.
20 Years
85 Years
ALL
No
Sponsors
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Qinghua Xia,Prof
OTHER_GOV
Responsible Party
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Qinghua Xia,Prof
Deputy Director of Urology, Shandong Provincial Hospital
Principal Investigators
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Qinghua Xia, Prof
Role: STUDY_DIRECTOR
Shandong Provincial Hospital
Locations
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Shandong Provincial Hospital
Jinan, Shandong, China
Countries
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Facility Contacts
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Other Identifiers
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ShandongPH Urology
Identifier Type: -
Identifier Source: org_study_id
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