Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Urothelial Carcinoma of the Upper Urinary Tract
Participants will have a nephroureterectomy (taking the kidney and the ureter).
Investigators will also be doing a lymph node dissection (taking the patient's lymph nodes
in the same side of the kidney) to look for malignancy outside of the kidney and ureter. The
lymph nodes will be sent to pathology for review.
Study visits will be scheduled 10 to 14 days after surgery for removal of stitches and
analysis of the patient's pathology report.
The following procedures will be done:
- History and physical examination, urinary cytology (test to look for malignant cells in
the urine) and surveillance cystoscopy (procedure to look inside the urethra and
bladder which is performed in the office under local anesthesia) every 3 months for the
first 2 years after treatment, every 6 months for the next 2 years and yearly
thereafter if the patient is free from recurrence.
- Radiographic studies including chest x-ray and abdomino-pelvic computed tomography (CAT
scans) will be performed every 6 months for the first 2 years and then yearly
- Bone scan (special imaging study to look for cancer spread in bone) in case of bone
pain or elevated alkaline phosphatase level.
After surgery patients will be followed every 3 months for the first 2 years after
treatment, every 6 months for the next 2 years and yearly thereafter if they are free from
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Number of Participants With Pathologically Proven Lymph Node Metastasis
The number of participants having pathologically proven lymph node metastasis at the time of radical nephroureterectomy (RNU) and modified retroperitoneal lymph node dissection (RPLND). The primary endpoint is the detection via lymph node dissection of pathological node positive urothelial carcinoma in patients treated with open or laparoscopic nephroureterectomy for upper tract urothelial cancer.
Up to 4 years
Philippe Spiess, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|