A Prospective Randomized Controlled Trial for Postoperative Adjuvant Chemotherapy for pTanyN0M0 Upper Urinary Urothelial Carcinoma With Lymphovascular Invasion
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Total tumor survival time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Gemcitabine (Drug)
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.
Intervention: Placebos (Drug)
Outcomes
Primary Outcomes
Total tumor survival time
Time Frame: 3 years
Effect of postoperative adjuvant chemotherapy on total tumor survival time
Secondary Outcomes
- progression-free survival time(3 years)
Investigators
Qinghua Xia,Prof
Deputy Director of Urology, Shandong Provincial Hospital
Shandong Provincial Hospital