Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

NCT01157676 | Completed Results DMC

• 3 other identifiers: 20120408R01CA15538836911
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 16

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).

Conditions

Bladder Cancer Requiring Cystectomy

Keywords

open cystectomy; robotic assisted radical cystectomy; bladder cancer

Outcome Measures

Primary Outcomes (20)

• Percentage of Participants With 2-year Progression Free Survival (PFS)

  Progression will be determined by the treating physician using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria based on radiographic or pathological evidence of disease progression or death from disease.

  24 months

• Number of Participants With Positive Margins

  Evaluated are the number of participants with positive surgical, bladder, and urethral margins. Positive margin is defined as presence of tumor cells at the edge of the dissected tissue.

  At time of cystectomy, approximately 1 hour.

• Number of Participants Requiring Lymph Node Dissection

  Evaluated are the number of participants requiring extended or standard lymph node dissection

  At time of cystectomy, approximately 1 hour

• Quality of Life (QOL) Outcomes

  Functional Assessment of Cancer Therapy- Vanderbilt Cystectomy Index (FACT-VCI) scores range is 0-168 which is sum of physical, emotional, wellbeing, and FACTS Bl Cys. higher scores=better QOL.

  at baseline, 3 month, and 6 months

• Number of Participants With Post-surgical Complications

  Post surgical complications will be evaluated using the Clavien grading system with scores ranging from 0-5 with the higher number indicating increased post-surgical complications.

  90 days post operative

• Amount of Estimated Blood Loss (EBL) in ml

  Perioperative measures such as EBL will be evaluated by measuring the amount of participant blood loss in ml.

  At time of cystectomy, approximately 1 hour

• Number of Participants Requiring Blood Transfusion

  Number of participants requiring peri, intra, and post operative blood transfusion.

  At time of cystectomy, approximately 1 hour

• Number of Days of Post Operative Length of Hospital Stay

  Number of days of post operative length of hospital stay will be evaluated

  Day 10 post surgery

• Length of Operative Time

  Length of minutes of cystectomy procedure

  At time of cystectomy, approximately 1 hour

• Laboratory Values

  Serum Hemoglobin (Hb) and Albumin will be reported in grams per deciliters (g/dL)

  baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months

• Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire

  Participant reported ADL questionnaire is a 7 item questionnaire with scores ranging from 7-21 with a lower score indicating increased independence.

  baseline, 1 month , 3 months, 6 months

• Percentage of Participants With 3-year Progression Free Survival (PFS)

  Progression will be determined by the treating physician using the RECIST Version 1.1 criteria based on radiographic or pathological evidence of disease progression or death from disease.

  3 years

• Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire

  The SF-8 consists of two component summary scores; physical (PCS) and mental component summary (MCS). They are scored by weighting each score to a norm-based scoring model. The total scores will be reported as a percentile with higher score indicating better quality of health.

  baseline, 3 month, and 6 month

• Total Number of Participants Requiring Intra-operative Fluid Requirement

  Total number of participants requiring Intra-operative fluid requirement. (blood+plasma+platelets) Note: In robotic group 1 participant received both plasma and platelets and 1 other received platelets in addition to blood transfusion. In the open group 5 participants received plasma in addition to blood transfusion.

  At time of cystectomy, approximately 1 hour

• Total Postoperative Analgesic Requirements

  Total postoperative analgesic requirements in milli grams

  At time of cystectomy, approximately 1 hour

• Creatinine Value.

  Serum creatinine will be reported in milligrams per deciliters (mg/dL).

  baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months

• Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire

  Participant reported IADL questionnaire is an 8 item questionnaire with scores ranging from 8-32 with a lower score indicating increased independence.

  baseline, 1 month, 3 months, 6 months

• Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test

  The hand grip strength test is measured in kilograms of pressure using a handheld dynamometer.

  baseline, 1 month, 3 months, 6 months

• Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test

  The TUG test is measured in seconds. Patients will be timed as they rise from a standard chair, walk 3 meters, turn, walk back, and sit again.

  baseline, 1 month, 3 months, 6 months

• Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire

  FACT-VCI consists of eight domains: Five subscale scores (physical wellbeing, social wellbeing, emotional wellbeing, functional wellbeing, and FACT for patients with Bladder Cancer following Cystectomy \[FACT-BL-Cys\]) and three derived scores (trial outcome index), FACT-General form (FACT-G), and FACT-BL-Cys Total.The ranges of scores for each domain are as follows: 0-28 for physical, social, and functional wellbeing; 0-24 for emotional wellbeing; 0-60 for FACT-BL-Cys; 0-116 for FACT-VCI Trial Outcome Index (sum of physical wellbeing, functional wellbeing, and FACT-BL-Cys scores); 0-108 for FACT-G (sum of physical, social, emotional, and functional wellbeing scores); and 0-168 for FACT-BL-Cys Total (sum of physical, social, emotional, and functional wellbeing scores, and FACT-BL-Cys).The higher score indicates increased wellbeing.

  baseline, 3 months, 6 months

Secondary Outcomes (1)

• Cost

  Day 7

Study Arms (2)

Open cystectomy

ACTIVE COMPARATOR

Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis.

Procedure: Open radical cystectomy

Robotic assisted radical cystectomy

ACTIVE COMPARATOR

Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach.

Procedure: Robotic assisted radical cystectomy; Device: DaVinci robot

Interventions

Open radical cystectomy PROCEDURE

Standard of care removal of urinary bladder.

Open cystectomy

Robotic assisted radical cystectomy PROCEDURE

Standard of care removal of urinary bladder using DaVinci robot.

Robotic assisted radical cystectomy

DaVinci robot DEVICE

DaVinci robotic surgical system.

Robotic assisted radical cystectomy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Inability to give informed consent.
• Prior major abdominal and pelvic open surgical procedures that would preclude a safe robotic approach, as determined by the treating surgeon.
• 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.
• Age \<18 or \>99 years.
• Pregnancy.

Sponsors & Collaborators

• University of Miami: lead
• National Cancer Institute (NCI): collaborator

Study Sites (16)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

University of California, Irvine Medical Center (UC Irvine)

Orange, California, 92868, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

The University of Texas Health Science Center at San Antonio, Medical Arts & Research Center

San Antonio, Texas, 78229, United States

Location

University of Virginia Health Science Center, Department of Urology

Charlottesville, Virginia, 22908, United States

Location

Cancer Research and Biostatistics (Data Management and Statistical Office)

Seattle, Washington, 98101, United States

Location

Related Publications (3)

• Venkatramani V, Reis IM, Gonzalgo ML, Swain S, Svatek RS, Parekh DJ. Comparison of Complication and Readmission Rates Between Robot-Assisted and Open Radical Cystectomy: Results From the Randomized RAZOR Clinical Trial. J Urol. 2025 Jun;213(6):684-692. doi: 10.1097/JU.0000000000004497. Epub 2025 Mar 13.

  PMID: 40080805 DERIVED

• 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.

  PMID: 35171260 DERIVED

• 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.

  PMID: 29976469 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dipen Parekh, MD
• Organization: University of Miami

parekhd@miami.med.edu

305 243 6591

Study Officials

• Dipen J Parekh, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Urology

Model Details: Non inferiority phase 3 randomized clinical trial comparing robotic to open radical cystectomy

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 7, 2010
• Study Start: July 1, 2011
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 3, 2020
• Results First Posted: January 13, 2020

Record last verified: 2020-10

Locations

US (16)