Clinical trial NCT01157676: Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
Official title: Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer Requiring Cystectomy
Keywords: open cystectomy
robotic assisted radical cystectomy
bladder cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-07-07
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non inferiority phase 3 randomized clinical trial comparing robotic to open radical cystectomy
Primary purpose: TREATMENT

Brief summary: This is a multi-institutional, randomized trial evaluating oncologic, perioperative, and functional outcomes following two standard care procedures for radical cystectomy. The participants will have one of the standard care procedures as part of their care. The two procedures that will be followed are open radical cystectomy and robotic assisted radical cystectomy (RARC). Open cystectomy is considered to be the more traditional approach. While newer, RARC is considered to be equivalent to open surgery when it is performed by a trained robotics surgeon. The reported complication rates of RARC appear comparable to open surgery. This means there is no significant difference in the risk between the two standard procedures. However, despite these potential advantages, true comparison between the open and robotic technique with regards to long term cancer related and functional outcomes has not been accomplished because previous studies did not compare patients of equal health status. The researchers hope to learn whether or not patients undergoing RARC recover more quickly than or at the same rate as patients undergoing an open radical cystectomy while having non inferior cancer related outcomes. This study is funded by the National Institutes of Health (NIH).


Eligibility criteria: Inclusion Criteria:

1. Patient must have biopsy proven bladder cancer. Official pathology report reviewed at the participating institution is required.
2. Bladder cancer must be clinical stage T1-T4, N0-1, M0. (AJCC 7th edition) or refractory cis (carcinoma in situ).

Exclusion Criteria:

1. Inability to give informed consent.
2. Prior major abdominal and pelvic open surgical procedures that would preclude a safe robotic approach, as determined by the treating surgeon.
3. At the discretion of the treating surgeon, any pre-existing condition such as severe chronic obstructive pulmonary disease that precludes a safe initiation or maintenance of pneumoperitoneum over a prolonged period of time and during surgery.
4. Age \<18 or \>99 years.
5. Pregnancy.

Primary outcomes:
measure: Percentage of Participants With 2-year Progression Free Survival (PFS)
timeFrame: 24 months
measure: Number of Participants With Positive Margins
timeFrame: At time of cystectomy, approximately 1 hour.
measure: Number of Participants Requiring Lymph Node Dissection
timeFrame: At time of cystectomy, approximately 1 hour
measure: Quality of Life (QOL) Outcomes
timeFrame: at baseline, 3 month, and 6 months
measure: Number of Participants With Post-surgical Complications
timeFrame: 90 days post operative
measure: Amount of Estimated Blood Loss (EBL) in ml
timeFrame: At time of cystectomy, approximately 1 hour
measure: Number of Participants Requiring Blood Transfusion
timeFrame: At time of cystectomy, approximately 1 hour
measure: Number of Days of Post Operative Length of Hospital Stay
timeFrame: Day 10 post surgery
measure: Length of Operative Time
timeFrame: At time of cystectomy, approximately 1 hour
measure: Laboratory Values
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months
measure: Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire
timeFrame: baseline, 1 month , 3 months, 6 months
measure: Percentage of Participants With 3-year Progression Free Survival (PFS)
timeFrame: 3 years
measure: Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire
timeFrame: baseline, 3 month, and 6 month
measure: Total Number of Participants Requiring Intra-operative Fluid Requirement
timeFrame: At time of cystectomy, approximately 1 hour
measure: Total Postoperative Analgesic Requirements
timeFrame: At time of cystectomy, approximately 1 hour
measure: Creatinine Value.
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months
measure: Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire
timeFrame: baseline, 1 month, 3 months, 6 months
measure: Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test
timeFrame: baseline, 1 month, 3 months, 6 months
measure: Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test
timeFrame: baseline, 1 month, 3 months, 6 months
measure: Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: Cost
timeFrame: Day 7
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Orange
country: United States
facility: University of California, Irvine Medical Center (UC Irvine)
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio, Medical Arts & Research Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health Science Center, Department of Urology
state: Virginia
city: Seattle
country: United States
facility: Cancer Research and Biostatistics (Data Management and Statistical Office)
state: Washington
Study officials:
affiliation: University of Miami
name: Dipen J Parekh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Venkatramani V, Reis IM, Gonzalgo ML, Castle EP, Woods ME, Svatek RS, Weizer AZ, Konety BR, Tollefson M, Krupski TL, Smith ND, Shabsigh A, Barocas DA, Quek ML, Dash A, Parekh DJ. Comparison of Robot-Assisted and Open Radical Cystectomy in Recovery of Patient-Reported and Performance-Related Measures of Independence: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2148329. doi: 10.1001/jamanetworkopen.2021.48329.
citation: Parekh DJ, Reis IM, Castle EP, Gonzalgo ML, Woods ME, Svatek RS, Weizer AZ, Konety BR, Tollefson M, Krupski TL, Smith ND, Shabsigh A, Barocas DA, Quek ML, Dash A, Kibel AS, Shemanski L, Pruthi RS, Montgomery JS, Weight CJ, Sharp DS, Chang SS, Cookson MS, Gupta GN, Gorbonos A, Uchio EM, Skinner E, Venkatramani V, Soodana-Prakash N, Kendrick K, Smith JA Jr, Thompson IM. Robot-assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR): an open-label, randomised, phase 3, non-inferiority trial. Lancet. 2018 Jun 23;391(10139):2525-2536. doi: 10.1016/S0140-6736(18)30996-6.