Lymph Node Dissection in High-risk UTUC(Upper Tract Urothelial Carcinoma)
UTUC
Impact of Lymph Node Dissection in the Management of High-risk Primary Upper Tract Urothelial Carcinoma Patients
1 other identifier
interventional
80
1 country
1
Brief Summary
This clinical trial is designed to evaluate the role of lymph node dissection in the prevention of recurrence and metastasis after radical nephroureterectomy for high-risk primary upper tract urothelial carcinoma (UTUC) patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 24, 2017
CompletedFirst Posted
Study publicly available on registry
July 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedAugust 8, 2017
August 1, 2017
4 years
July 24, 2017
August 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
overall survival
three years after surgery
Secondary Outcomes (4)
postoperative morbidity and mortality
three years after surgery
recurrence-free survival
three years after surgery
cancer specific survival
three years after surgery
event-free survival
three years after surgery
Study Arms (2)
Blank control
NO INTERVENTIONdo not receive Lymph node dissection during surgery.
Lymph node dissection
EXPERIMENTALwill receive Lymph node dissection during radical nephroureterectomy.
Interventions
Lymph node dissection during radical nephroureterectomy
Eligibility Criteria
You may qualify if:
- I. Suspected high-risk UTUC patients without metastases in their preoperative radiological imaging (cN0M0).II. Suspected high-risk UTUC patients without history of bladder tumor.
- III. Suspected high-risk UTUC patients without synchronous bladder tumor. IV. Suspected high-risk UTUC patients without contralateral UTUCs
You may not qualify if:
- I. Patients with significant metastases in their preoperative radiological imaging.
- II. Patients with history of bladder tumor. III. Patients with synchronous bladder tumor. IV. Patients with contralateral UTUCs. V. Patients with advanced stage (T4). VI. Patients with other malignant tumors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Liqun Zhou, M.D.
Peking University First Hosipital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 24, 2017
First Posted
July 26, 2017
Study Start
January 1, 2017
Primary Completion
January 1, 2021
Study Completion
January 1, 2021
Last Updated
August 8, 2017
Record last verified: 2017-08