Trials / Unknown
UnknownNCT04255771
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
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Qinghua Xia,Prof · Other Government
- Sex
- All
- Age
- 20 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DRUG | Placebos | Use a placebo as a comparison |
Timeline
- Start date
- 2020-03-01
- Primary completion
- 2023-03-01
- Completion
- 2023-06-01
- First posted
- 2020-02-05
- Last updated
- 2020-02-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04255771. Inclusion in this directory is not an endorsement.