Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection

Completed · Not applicable

Conditions studied: Cancer of the Urinary Tract

In brief

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).

Key facts

Study ID

NCT00751140

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

20

Starts

2008-09-01

Expected to finish

2012-04-01

Last updated by the study team

2017-05-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with suspected transitional cell carcinoma of the upper urinary tract which are deemed surgical candidates
• Negative visible retroperitoneal or peri-hilar lymphadenopathy on pre-operative radiographic studies. Defined as the absence of suspicious abdominal, retroperitoneal, or pelvic lymphadenopathy (defined as > 1 centimeter [cm]) on pre-operative radiographic imaging (Abdominal and pelvic computed tomography [CT] or magnetic resonance imaging [MRI] if CT contraindicated). Imaging studies can be done at Moffitt or at a local facility of the patient's choice. All imaging studies are going to be reviewed at Moffitt.
• Note: Nodal involvement will depend on the size of the lymph node enlargement; usually nodes of more than 2 cm are associated with malignancy. With a threshold of 1cm, false negative rates for microscopic metastases are low (4%) and false positive rates are between 3 to 43% according to the literature. Because the aim of the study will be to perform a lymph node dissection in patients with non-metastatic disease based on pre-operative evaluation, 1 cm will be the threshold used. Nodes of more than 1 cm will be considered positive and those patients will be excluded as is mentioned in the protocol. Biopsy will not be included as part of the protocol as those potential patients with nodes of more than 1 cm will be excluded.
• No other suspected sites of metastasis on pre-operative radiographic imaging

You may not qualify if…

• Patients with visible lymph node metastasis on pre-operative radiographic studies. Defined as >1cm abdominal, retroperitoneal or pelvic lymphadenopathy
• Patients with suspected sites of distant metastasis on pre-operative imaging. (Patients with suspected bony metastases will require a bone scan.)
• Patients with suspected transitional cell carcinoma of the upper urinary tract with significant comorbidities making them non-surgical candidates
• Patients with non-transitional cell carcinoma of the upper urinary tract will be excluded from this study.

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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