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Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection

Primary Purpose

Cancer of the Urinary Tract

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lymph Node Dissection

About this trial

This is an interventional diagnostic trial for Cancer of the Urinary Tract focused on measuring surgical candidates, upper urinary tract, urothelial carcinoma, lymph node dissection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lymph Node Dissection at Time of Nephroureterectomy

Arm Description

A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT00751140

First Posted

September 10, 2008

Last Updated

April 26, 2017

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT00751140

Brief Title

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

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of the Urinary Tract

Keywords

surgical candidates, upper urinary tract, urothelial carcinoma, lymph node dissection

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lymph Node Dissection at Time of Nephroureterectomy

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Lymph Node Dissection

Other Intervention Name(s)

nephroureterectomy

Intervention Description

The lymph nodes will be sent to pathology for review.

Primary Outcome Measure Information:

Title

Number of Participants With Pathologically Proven Lymph Node Metastasis

Description

Time Frame

Up to 4 years

Secondary Outcome Measure Information:

Title

Surgical Outcomes: Mean Lymph Node Count

Description

Time Frame

2 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe Spiess, M.D.

Organizational Affiliation

H. Lee Moffitt Cancer Center and Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

H. Lee Moffitt Cancer Center and Research Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

12. IPD Sharing Statement

Links:

URL

https://www.ncbi.nlm.nih.gov/pubmed/22564727

Description

Prospective clinical trial of the feasibility and safety of modified retroperitoneal lymph node dissection at time of nephroureterectomy for upper tract urothelial carcinoma.

Learn more about this trial

Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection

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