Trial Outcomes & Findings for Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection (NCT NCT00751140)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Up to 4 years

Results posted on

2017-05-30

Participant Flow

Sample: Up to 30 patients with a diagnosis of urothelial carcinoma of the upper urinary tract in the absence of pre-operative (radiographic) lymphadenopathy or other areas of suspected metastatic disease were planned to serve as the investigators' study sample population.

Participant milestones

Participant milestones
Measure	Lymph Node Dissection at Time of Nephroureterectomy 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). Lymph Node Dissection : The lymph nodes will be sent to pathology for review.
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Lymph Node Dissection at Time of Nephroureterectomy 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). Lymph Node Dissection : The lymph nodes will be sent to pathology for review.
Overall Study benign angioma excluded from analysis	1

Baseline Characteristics

Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lymph Node Dissection at Time of Nephroureterectomy n=20 Participants 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). Lymph Node Dissection : The lymph nodes will be sent to pathology for review.
Age, Continuous	69 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 years

Population: All evaluable participants. On histopathological review, one patient had a benign angioma and was excluded from the final data analysis.

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 measures

Outcome measures
Measure	Lymph Node Dissection at Time of Nephroureterectomy n=19 Participants 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). Lymph Node Dissection : The lymph nodes will be sent to pathology for review.	Open RNU Lymph Node Count Lymph Node Count for Open RNU Procedure Group	Laparoscopic RNU Lymph Node Count Lymph Node Count for Laparoscopic RNU Procedure Group	Robot-assisted RNU Lymph Node Count Lymph Node Count for Robot-assisted RNU Procedure Group
Number of Participants With Pathologically Proven Lymph Node Metastasis	1 participants	—	—	—

SECONDARY outcome

Timeframe: 2 years

Population: Total Participants and Participants Per Procedure Category

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).

Outcome measures

Outcome measures
Measure	Lymph Node Dissection at Time of Nephroureterectomy n=20 Participants 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). Lymph Node Dissection : The lymph nodes will be sent to pathology for review.	Open RNU Lymph Node Count n=9 Participants Lymph Node Count for Open RNU Procedure Group	Laparoscopic RNU Lymph Node Count n=4 Participants Lymph Node Count for Laparoscopic RNU Procedure Group	Robot-assisted RNU Lymph Node Count n=7 Participants Lymph Node Count for Robot-assisted RNU Procedure Group
Surgical Outcomes: Mean Lymph Node Count	7 Lymph Nodes Interval 2.0 to 17.0	7 Lymph Nodes Interval 2.0 to 17.0	8 Lymph Nodes Interval 3.0 to 14.0	6 Lymph Nodes Interval 2.0 to 10.0

Adverse Events

Lymph Node Dissection at Time of Nephroureterectomy

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lymph Node Dissection at Time of Nephroureterectomy n=19 participants at risk 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). Lymph Node Dissection : The lymph nodes will be sent to pathology for review.
Renal and urinary disorders Chylous leak requiring surgical exploration - Grade IIIb	5.3% 1/19 • Number of events 1 • 2 years

Other adverse events

Other adverse events
Measure	Lymph Node Dissection at Time of Nephroureterectomy n=19 participants at risk 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). Lymph Node Dissection : The lymph nodes will be sent to pathology for review.
Renal and urinary disorders Blood Transfusion - Grade II	31.6% 6/19 • Number of events 6 • 2 years
Renal and urinary disorders Postoperative ileus - Grade II	5.3% 1/19 • Number of events 1 • 2 years
Renal and urinary disorders Chylous leak managed conservatively - Grade II	5.3% 1/19 • Number of events 1 • 2 years

Additional Information

Philippe E. Spiess, M.D.

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-8343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place