Clinical trial NCT00751140: Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of the Urinary Tract
Keywords: surgical candidates
upper urinary tract
urothelial carcinoma
lymph node dissection
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2008-09-11
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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).

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 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.

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.

Primary outcomes:
measure: Number of Participants With Pathologically Proven Lymph Node Metastasis
timeFrame: Up to 4 years
Secondary outcomes:
measure: Surgical Outcomes: Mean Lymph Node Count
timeFrame: 2 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Philippe Spiess, M.D.
role: PRINCIPAL_INVESTIGATOR
References: