Status:
COMPLETED
Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Conditions:
Cancer of the Urinary Tract
Eligibility:
All Genders
Phase:
NA
Brief Summary
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 potentia...
Detailed Description
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 kidne...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00751140
Start Date
September 1 2008
End Date
April 1 2012
Last Update
May 30 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612