Bladder Cancer Requiring CystectomyNCT01157676
Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
A study testing Open radical cystectomy, Robotic assisted radical cystectomy and DaVinci robot in people with Bladder Cancer Requiring Cystectomy, run by University of Miami at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer Requiring Cystectomy
- What is being tested?
- Open radical cystectomy, Robotic assisted radical cystectomy and DaVinci robot
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 16 sitesUnited States
- Study dates
- Jul 2011to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Virginia Health Science Center, Department of Urology
Charlottesville, Virginia, 22908
University of Chicago Medical Center
Chicago, Illinois, 60637
Ohio State University Medical Center
Columbus, Ohio, 43210
Loyola University Medical Center
Maywood, Illinois, 60153
University of Miami
Miami, Florida, 33136
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of California, Irvine Medical Center (UC Irvine)
Orange, California, 92868
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
The University of Texas Health Science Center at San Antonio, Medical Arts & Research Center
San Antonio, Texas, 78229
Cancer Research and Biostatistics (Data Management and Statistical Office)
Seattle, Washington, 98101
Stanford University
Stanford, California, 94305
About this study
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
- Being tested
- Open radical cystectomy, Robotic assisted radical cystectomy, DaVinci robot
- Keywords
- open cystectomy, robotic assisted radical cystectomy, bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open radical cystectomyProcedure or surgery
Standard of care removal of urinary bladder.
Robotic assisted radical cystectomyProcedure or surgery
Standard of care removal of urinary bladder using DaVinci robot.
DaVinci robotDevice
DaVinci robotic surgical system.
| Study group | Role | What they receive |
|---|---|---|
| Open cystectomy | Active comparator | Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis. Receives: Procedure: Open radical cystectomy |
| Robotic assisted radical cystectomy | Active comparator | Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach. Receives: Procedure: Robotic assisted radical cystectomy; Device: DaVinci robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At time of cystectomy, approximately 1 hour
Number of Participants Requiring Blood Transfusion
Number of participants requiring peri, intra, and post operative blood transfusion.
Measured: 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
Measured: Day 10 post surgery
Length of Operative Time
Length of minutes of cystectomy procedure
Measured: At time of cystectomy, approximately 1 hour
Laboratory Values
Serum Hemoglobin (Hb) and Albumin will be reported in grams per deciliters (g/dL)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At time of cystectomy, approximately 1 hour
Total Postoperative Analgesic Requirements
Total postoperative analgesic requirements in milli grams
Measured: At time of cystectomy, approximately 1 hour
Creatinine Value.
Serum creatinine will be reported in milligrams per deciliters (mg/dL).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 3 months, 6 months
Secondary outcomes (1)
Cost
Fixed and variable costs associated with the procedure.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startJul 2011
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bladder Cancer Requiring CystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non inferiority phase 3 randomized clinical trial comparing robotic to open radical cystectomy
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Dipen J Parekh, MD, University of Miami
- Investigators
- Dipen J Parekh, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157676
- Sponsor's protocol ID
- 20120408
- Other IDs
- R01CA155388, 36911
- Status last verified
- Oct 2020
- First submitted
- 30 Jun 2010
- Last updated
- 3 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 40080805Venkatramani 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.
PubMed 35171260Parekh 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.
PubMed 29976469
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01157676
- Acronym / sponsor ID
- 20120408
- Conditions
- Bladder Cancer Requiring Cystectomy
- Keywords
- open cystectomy, robotic assisted radical cystectomy, bladder cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2011
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 7 Jul 2010 (estimated)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non inferiority phase 3 randomized clinical trial comparing robotic to open radical cystectomy
| Arm | Type | Receives |
|---|---|---|
| Open cystectomy | Active comparator | Procedure: Open radical cystectomyOpen cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis. |
| Robotic assisted radical cystectomy | Active comparator | Procedure: Robotic assisted radical cystectomy, Device: DaVinci robotRobotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open radical cystectomyStandard of care removal of urinary bladder. | Procedure or surgery | Open cystectomy |
| Robotic assisted radical cystectomyStandard of care removal of urinary bladder using DaVinci robot. | Procedure or surgery | Robotic assisted radical cystectomy |
| DaVinci robotDaVinci robotic surgical system. | Device | Robotic assisted radical cystectomy |
Primary outcome
Percentage of Participants With 2-year Progression Free Survival (PFS)
Time frame: 24 months
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.
Number of Participants With Positive Margins
Time frame: At time of cystectomy, approximately 1 hour.
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.
Number of Participants Requiring Lymph Node Dissection
Time frame: At time of cystectomy, approximately 1 hour
Evaluated are the number of participants requiring extended or standard lymph node dissection
Quality of Life (QOL) Outcomes
Time frame: at baseline, 3 month, and 6 months
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.
Number of Participants With Post-surgical Complications
Time frame: 90 days post operative
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.
Amount of Estimated Blood Loss (EBL) in ml
Time frame: At time of cystectomy, approximately 1 hour
Perioperative measures such as EBL will be evaluated by measuring the amount of participant blood loss in ml.
Number of Participants Requiring Blood Transfusion
Time frame: At time of cystectomy, approximately 1 hour
Number of participants requiring peri, intra, and post operative blood transfusion.
Number of Days of Post Operative Length of Hospital Stay
Time frame: Day 10 post surgery
Number of days of post operative length of hospital stay will be evaluated
Length of Operative Time
Time frame: At time of cystectomy, approximately 1 hour
Length of minutes of cystectomy procedure
Laboratory Values
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months
Serum Hemoglobin (Hb) and Albumin will be reported in grams per deciliters (g/dL)
Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire
Time frame: baseline, 1 month , 3 months, 6 months
Participant reported ADL questionnaire is a 7 item questionnaire with scores ranging from 7-21 with a lower score indicating increased independence.
Percentage of Participants With 3-year Progression Free Survival (PFS)
Time frame: 3 years
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.
Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire
Time frame: baseline, 3 month, and 6 month
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.
Total Number of Participants Requiring Intra-operative Fluid Requirement
Time frame: At time of cystectomy, approximately 1 hour
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.
Total Postoperative Analgesic Requirements
Time frame: At time of cystectomy, approximately 1 hour
Total postoperative analgesic requirements in milli grams
Creatinine Value.
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months
Serum creatinine will be reported in milligrams per deciliters (mg/dL).
Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire
Time frame: baseline, 1 month, 3 months, 6 months
Participant reported IADL questionnaire is an 8 item questionnaire with scores ranging from 8-32 with a lower score indicating increased independence.
Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test
Time frame: baseline, 1 month, 3 months, 6 months
The hand grip strength test is measured in kilograms of pressure using a handheld dynamometer.
Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test
Time frame: baseline, 1 month, 3 months, 6 months
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.
Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire
Time frame: baseline, 3 months, 6 months
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.
1 secondary outcome
Cost
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40080805Venkatramani 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.
- Derived from this study: PubMed 35171260Venkatramani 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.
- Derived from this study: PubMed 29976469Parekh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dipen J Parekh, MD principal investigator
University of Miami
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open radical cystectomy, Robotic assisted radical cystectomy and DaVinci robot in people with Bladder Cancer Requiring Cystectomy, run by University of Miami at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With 2-year Progression Free Survival (PFS) (time frame: 24 months). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01157676, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.