Cancer of the Urinary Tract Clinical Trial
Official title:
Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Urothelial Carcinoma of the Upper Urinary Tract
The primary objective is to show that performing a lymph node dissection may detect occult
nodal metastasis in this patient population whereby providing important diagnostic
information, with potential therapeutic benefits in patients with isolated nodal metastases.
In case of urothelial carcinoma of the upper urinary tract (a cancer originating from the
inner lining of the urinary tract) requiring the removal of the kidney, ureter, and cuff of
bladder (a surgical termed a nephroureterectomy). Previous studies in urothelial carcinoma
of the bladder, have shown that doing a lymph node dissection (surgically removing the lymph
nodes) may improve survival, or at least give an idea of what patients may need chemotherapy
(drugs to control the cancer cells that are outside the kidney-ureter) earlier (before the
nodes are enlarged in the imaging studies).
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
thereafter.
- 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
recurrence.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic