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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02252393
Other study ID # CASE7814
Secondary ID NCI-2014-01530CA
Status Withdrawn
Phase N/A
First received September 26, 2014
Last updated November 8, 2016
Start date October 2015
Est. completion date November 2016

Study information

Verified date November 2016
Source Case Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This randomized clinical trial studies intracorporeal or extracorporeal urinary diversion during robotic assisted radical cystectomy in reducing complications in patients with bladder cancer. Radical cystectomy is surgery to remove the entire bladder as well as nearby tissues and organs. After the bladder is removed, urinary diversion (a surgical procedure to make a new way for urine to leave the body) is performed. It is not yet known whether intracorporeal (within the body) or extracorporeal (outside of the body) urinary diversion is a better method in patients with bladder cancer undergoing robotic assisted radical cystectomy.


Description:

PRIMARY OBJECTIVES:

I. To compare perioperative outcomes and complications after robotic assisted radical cystectomy (RARC) with intracorporeal urinary diversion (IUD) and RARC with extracorporeal urinary diversion (EUD) in a prospective randomized fashion.

SECONDARY OBJECTIVES:

I. Time to passage of flatus. II. Analgesic requirement (narcotic use). III. Hospital length of stay. IV. Total operating time. V. Estimated blood loss. VI. Readmission rate. VII. Bladder Cancer Index Questionnaire. VIII. Ureteral strictures. IX. Stomal stenosis. X. Disease recurrence. XI. Secondary procedures.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo RARC with IUD.

ARM II: Patients undergo RARC with EUD.

After completion of study treatment, patients are followed up within 90 days and then for 2-5 years.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Grade G1 - G3 bladder cancer

- T stage: cTis - T2

- N0

- M0

- American Society of Anesthesiologists (ASA) < 4

- Informed consent

- Eastern Cooperative Oncology Group (ECOG) performance status 2 or better

- Hemoglobin (Hgb) > 8.0 g/dL

- White blood cell (WBC) > 2.0 k/uL

- Platelets > 50,000

- Creatinine < 3.0 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST) < 5.0 x ULN

- Alanine transaminase (ALT) < 5.0 x ULN

Exclusion Criteria:

- Patient unsuitable for or refusing radical cystectomy

- T stage = T3 (mass extending outside the bladder)

- Gross nodal or metastatic disease at presentation (= N1, M1)

- Prior pelvic radiation

- Prior open or laparoscopic/robotic bladder or prostate surgery

- Prior colorectal surgery or history of inflammatory bowel disease

- Body mass index (BMI) = 40

- ECOG performance status 3 or worse

- History of coagulopathy or bleeding disorders

- Chronic steroid use

- Patients with end stage renal disease (ESRD) and/or on dialysis

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Procedure:
robot-assisted laparoscopic surgery
Undergo RARC with IUD
robot-assisted laparoscopic surgery
Undergo RARC with EUD
Other:
intraoperative complication management/prevention
Undergo RARC with IUD
intraoperative complication management/prevention
Undergo RARC with EUD
quality-of-life assessment
Ancillary studies

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center National Cancer Institute (NCI)

Outcome

Type Measure Description Time frame Safety issue
Primary Complication rate Analyzed using multivariable logistical regression. Descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for adverse event reporting. 90 days after surgery Yes
Secondary Time to passage of flatus Analyzed using regression analysis. Up to 90 days No
Secondary Analgesic requirement (narcotic use) Analyzed using logistical regression. Up to 90 days No
Secondary Hospital length of stay Analyzed using regression analysis. Up to 90 days No
Secondary Total operating time Analyzed using regression analysis. Up to completion of surgery No
Secondary Estimated blood loss Analyzed using regression analysis. Up to 90 days No
Secondary Readmission rate Analyzed using regression analysis. Up to 90 days No
Secondary Quality of life assessed using the Bladder Cancer Index Questionnaire The Cox proportional hazards model will be used. The hazard ratio (HR) and 95% confidence interval (95% CI) associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated. Up to 5 years No
Secondary Ureteral strictures The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated. Up to 5 years No
Secondary Stromal stenosis The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated. Up to 5 years No
Secondary Disease recurrence The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated. Up to 5 years No
Secondary Secondary procedures The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated. Up to 5 years No
Secondary Cumulative complication incidence Graphically described using the Kaplan-Meier method. Descriptions and grading scales found in the NCI CTCAE version 4.0 will be utilized for adverse event reporting. Up to 5 years Yes
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