Prospective Randomized Phase II Trial: Comparing the Prognostic Value of Routine Lymphadenectomy Versus Lymphadenectomy Only for Lymph Nodes Enlargement Found in Preoperative Imaging or During Surgery Undergoing Nephroureterectomy in Patients With Primary Upper Tract Urothelial Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Lymph Node Dissection
- Sponsor
- RenJi Hospital
- Enrollment
- 504
- Locations
- 2
- Primary Endpoint
- Disease free survival
- Last Updated
- 7 years ago
Overview
Brief Summary
Recent studies showed the therapeutic benefit of lymphadenectomy in advanced stage urothelial carcinoma of the upper urinary tract, but there is still a lack of prospective studies. Thus, the current guideline recommends lymph node dissection for invasive upper tract urothelial carcinoma (UTUC) on the basis of insufficient evidence. Also, the preoperative judgment of muscle invasive pathological stage T 2+,or N+ is difficult from preoperative imaging. In the investigators' clinical practice, the surgeons performed dissection of regional lymph nodes only in patients with enlargement of lymph nodes found in preoperative imaging or during surgery. The aim of this multi-institutional study was to examine the role of lymphadenectomy in urothelial carcinoma of the upper urinary tract.
Investigators
Eligibility Criteria
Inclusion Criteria
- •clinically diagnosed with upper tract urothelial carcinoma
- •have no distant metastasis
- •have an Eastern Cooperative Oncology Group (ECOG) score 0 to 2
- •expected to receive radical nephroureterectomy
Exclusion Criteria
- •a prior history of bladder cancer
- •administration of neoadjuvant chemotherapy
- •deny to receive long term follow-up
- •patients with contralateral UTUCs
- •patients with synchronous muscle invasive bladder cancer
Outcomes
Primary Outcomes
Disease free survival
Time Frame: 36 month
Disease free survival rate in the 36 month following nephroureterectomy
Secondary Outcomes
- Cancer specific survival(36 month)
- Overall survival(36 month)
- The recurrence rate of bladder cancer in the 36 month following nephroureterectomy(36 month)
- Perioperative complications rate(90 day)