Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Urothelial Carcinoma of the Upper Urinary Tract
N/A
N/A
Both
Cancer of the Urinary Tract
Trial Information
Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Urothelial Carcinoma of the Upper Urinary Tract
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Number of Participants With Pathologically Proven Lymph Node Metastasis
Outcome Description:
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.
Outcome Time Frame:
Up to 4 years
Safety Issue:
No
Principal Investigator
Philippe Spiess, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Institutional Review Board
Study ID:
MCC-15441
NCT ID:
NCT00751140
Start Date:
September 2008
Completion Date:
April 2012
Related Keywords:
- Cancer of the Urinary Tract
- surgical candidates
- upper urinary tract
- urothelial carcinoma
- lymph node dissection
- Carcinoma, Transitional Cell
- Urologic Neoplasms
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
