N/A
N=20
Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection
Cancer of the Urinary Tract
Bottom Line
View on ClinicalTrials.gov: NCT00751140 ↗Enrolled (actual)
20
Serious AEs
5.3%
Results posted
Jan 2013
Primary outcome: Primary: Number of Participants With Pathologically Proven Lymph Node Metastasis — 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lymph Node Dissection (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Pathologically Proven Lymph Node Metastasis |
1 | — |
| SECONDARY Surgical Outcomes: Mean Lymph Node Count |
7; 7; 8; 6 | — |
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 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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00751140). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.