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).
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | April 2012 |
| Est. primary completion date | April 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Surgical Outcomes: Mean Lymph Node Count | 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). | 2 years | No |