Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection

NCT00751140 | Completed Results DMC

• 2 other identifiers: MCC-1544110718
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer of the Urinary Tract

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 4 years

Secondary Outcomes (1)

• Surgical Outcomes: Mean Lymph Node Count

  2 years

Study Arms (1)

Lymph Node Dissection at Time of Nephroureterectomy

EXPERIMENTAL

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).

Procedure: Lymph Node Dissection

Interventions

Lymph Node Dissection PROCEDURE

The lymph nodes will be sent to pathology for review.

Also known as: nephroureterectomy

Lymph Node Dissection at Time of Nephroureterectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

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

MeSH Terms

Conditions

Urologic Neoplasms; Carcinoma, Transitional Cell

Interventions

Lymph Node Excision; Nephroureterectomy

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Nephrectomy; Urologic Surgical Procedures; Urogenital Surgical Procedures

Limitations and Caveats

The sample size was small because it was a single institution study. It was thus underpowered to achieve a cancer-specific endpoint pertaining to the oncological merit of performing a modified RPLND in the context of UUT-UC.

Results Point of Contact

• Title: Philippe E. Spiess, M.D.
• Organization: H. Lee Moffitt Cancer Center and Research Institute

philippe.spies@moffitt.org

813-745-8343

Study Officials

• Philippe Spiess, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2008
• First Posted: September 11, 2008
• Study Start: September 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 30, 2017
• Results First Posted: January 8, 2013

Record last verified: 2012-12

Locations

US (1)