Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection
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|ClinicalTrials.gov Identifier: NCT00751140|
Recruitment Status : Completed
First Posted : September 11, 2008
Results First Posted : January 8, 2013
Last Update Posted : May 30, 2017
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).
|Condition or disease||Intervention/treatment||Phase|
|Cancer of the Urinary Tract||Procedure: Lymph Node Dissection||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Urothelial Carcinoma of the Upper Urinary Tract|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Experimental: Lymph Node Dissection at Time of Nephroureterectomy
A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).
Procedure: Lymph Node Dissection
The lymph nodes will be sent to pathology for review.
Other Name: nephroureterectomy
- Number of Participants With Pathologically Proven Lymph Node Metastasis [ Time Frame: Up to 4 years ]
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.
- Surgical Outcomes: Mean Lymph Node Count [ Time Frame: 2 years ]The mean (range) total lymph node count and lymph node count per procedure category. Between 2009 and 2011, patients with suspected upper urinary tract urothelial carcinoma (UUT-UC) underwent open, laparoscopic, or robot-assisted radical nephroureterectomy (RNU) with modified retroperitoneal lymph node dissection (RPLND).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751140
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Philippe Spiess, M.D.||H. Lee Moffitt Cancer Center and Research Institute|