Bladder CancerPhase 3NCT01076387
Randomized Trial Comparing Robotic and Open Radical Cystectomy
A Phase 3 study testing open radical cystectomy and robotic-assisted radical cystectomy in people with Bladder Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if using robotic surgical technology during bladder cancer surgery helps to reduce complications during and after the surgery. The removal of the bladder and lymph nodes will be done by a robotic or by an open technique. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- open radical cystectomy and robotic-assisted radical cystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to 12 Mar 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- Scheduled for radical cystectomy at MSKCC
Who cannot join
- Prior pelvic or abdominal radiation therapy;
- Prior extensive open abdominal surgery, defined by the discretion of the attending surgeon
- Any clinical contraindication for Trendelenburg positioning
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Prospective, Randomized Trial Comparing Robotic and Open Radical Cystectomy
The purpose of this study is to determine if using robotic surgical technology during bladder cancer surgery helps to reduce complications during and after the surgery. The removal of the bladder and lymph nodes will be done by a robotic or by an open technique. It may be a Robotic-assisted Radical Cystectomy (RARC) and Pelvic Lymph Node Dissection. Or it may be an Open Radical Cystectomy (ORC) and Pelvic Lymph Node Dissection.
- Conditions
- Bladder Cancer
- Being tested
- open radical cystectomy, robotic-assisted radical cystectomy
- Keywords
- Bladder, Cystectomy, Robotic, Open Radical, 10-016
- 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
Open radical cystectomy, pelvic lymph node dissection and open urinary diversion.
robotic-assisted radical cystectomyProcedure or surgery
Robotic radical cystectomy, pelvic lymph node dissection and open urinary diversion. Robotic radical cystectomy is routinely performed by robotically trained and experienced minimally invasive surgeons.
| Study group | Role | What they receive |
|---|---|---|
| open radical cystectomy | Active comparator | This is a prospective, randomized study designed to compare two techniques of radical cystectomy with PLND (open and robotic) for bladder cancer. Receives: Procedure: open radical cystectomy |
| robotic-assisted radical cystectomy | Active comparator | This is a prospective, randomized study designed to compare two techniques of radical cystectomy with PLND (open and robotic) for bladder cancer. Receives: Procedure: robotic-assisted radical cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy.
Measured: intraoperative and 90-day postoperative period
Secondary outcomes (6)
To examine clinical and pathological outcomes of robotic-assisted radical cystectomy and open radical cystectomy.
Measured: 2 years
Intra-operative performance (surgical time, blood loss)
Measured: time from anesthesia induction to final skin closure
Pathologic findings, including the stage specific, soft tissue surgical margin rate and number of lymph nodes removed.
Measured: 1.5 years
Bladder cancer recurrence (local, upper tract and distant disease)
Measured: 2 years
complications grade 2-5
A secondary analysis will be used to determine if the total burden of grade 2-5 complications in the robotic arm is different from the open arm.
Measured: 2 years
complication grade 3-5
Determine if there is a difference in either the number of patients with grade 3-5 complication or the total number of grade 3-5 complication in the two arms of the study.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Laudone, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076387
- Sponsor's protocol ID
- 10-016
- Status last verified
- Mar 2020
- First submitted
- 24 Feb 2010
- Last updated
- 16 Mar 2020
- Results posted
- No
Publications
Bochner BH, Dalbagni G, Sjoberg DD, Silberstein J, Keren Paz GE, Donat SM, Coleman JA, Mathew S, Vickers A, Schnorr GC, Feuerstein MA, Rapkin B, Parra RO, Herr HW, Laudone VP. Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial. Eur Urol. 2015 Jun;67(6):1042-1050. doi: 10.1016/j.eururo.2014.11.043. Epub 2014 Dec 8.
PubMed 25496767
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial Comparing Robotic and Open Radical Cystectomy
- ClinicalTrials.gov ID
- NCT01076387
- Acronym / sponsor ID
- 10-016
- Conditions
- Bladder Cancer
- Keywords
- Bladder, Cystectomy, Robotic, Open Radical, 10-016
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 26 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if using robotic surgical technology during bladder cancer surgery helps to reduce complications during and after the surgery. The removal of the bladder and lymph nodes will be done by a robotic or by an open technique. It may be a Robotic-assisted Radical Cystectomy (RARC) and Pelvic Lymph Node Dissection. Or it may be an Open Radical Cystectomy (ORC) and Pelvic Lymph Node Dissection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open radical cystectomy | Active comparator | Procedure: open radical cystectomyThis is a prospective, randomized study designed to compare two techniques of radical cystectomy with PLND (open and robotic) for bladder cancer. |
| robotic-assisted radical cystectomy | Active comparator | Procedure: robotic-assisted radical cystectomyThis is a prospective, randomized study designed to compare two techniques of radical cystectomy with PLND (open and robotic) for bladder cancer. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years.
- Scheduled for radical cystectomy at MSKCC
Key exclusion criteria (3 listed)
- Prior pelvic or abdominal radiation therapy;
- Prior extensive open abdominal surgery, defined by the discretion of the attending surgeon
- Any clinical contraindication for Trendelenburg positioning
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 cystectomyOpen radical cystectomy, pelvic lymph node dissection and open urinary diversion. | Procedure or surgery | open radical cystectomy |
| robotic-assisted radical cystectomyRobotic radical cystectomy, pelvic lymph node dissection and open urinary diversion. Robotic radical cystectomy is routinely performed by robotically trained and experienced minimally invasive surgeons. | Procedure or surgery | robotic-assisted radical cystectomy |
Primary outcome
To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy.
Time frame: intraoperative and 90-day postoperative period
6 secondary outcomes
To examine clinical and pathological outcomes of robotic-assisted radical cystectomy and open radical cystectomy.
Time frame: 2 years
Intra-operative performance (surgical time, blood loss)
Time frame: time from anesthesia induction to final skin closure
Pathologic findings, including the stage specific, soft tissue surgical margin rate and number of lymph nodes removed.
Time frame: 1.5 years
Bladder cancer recurrence (local, upper tract and distant disease)
Time frame: 2 years
complications grade 2-5
Time frame: 2 years
complication grade 3-5
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Derived from this study: PubMed 25496767Bochner BH, Dalbagni G, Sjoberg DD, Silberstein J, Keren Paz GE, Donat SM, Coleman JA, Mathew S, Vickers A, Schnorr GC, Feuerstein MA, Rapkin B, Parra RO, Herr HW, Laudone VP. Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial. Eur Urol. 2015 Jun;67(6):1042-1050. doi: 10.1016/j.eururo.2014.11.043. Epub 2014 Dec 8.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Vincent Laudone, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing open radical cystectomy and robotic-assisted radical cystectomy in people with Bladder Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site 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 3 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 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy. (time frame: intraoperative and 90-day postoperative period). 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 NCT01076387, which also lists 1 linked publication.
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 16 Mar 2020.