Bladder CancerPhase 2NCT00963859
Robotic-Assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder
A Phase 2 study testing Robotic-assisted laparoscopic surgery in people with Bladder Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to evaluate how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made, in patients who are having their bladder removed for the treatment of bladder cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Robotic-assisted laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jun 2011
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are eligible for a radical cystectomy and who, in the opinion of the treating MDACC physician, are candidates for a robotic-assisted laparoscopic technique for management of the bladder and lymph nodes.
- Diagnosis of transitional cell carcinoma of the bladder.
- Medical fitness for open radical cystectomy by consensus of MDACC urology and anesthesia faculty (medicine/cardiology clearance by common best practice criteria).
- Staging inclusion by cystoscopic biopsy and bimanual examination under anesthesia: carcinoma in-situ, T1, T2.
Who cannot join
- Prior pelvic radiation.
- Morbid obesity, i.e., body mass index (BMI)> 35.
- Metastatic disease, bulky disease--T3a/b, prostatic stromal invasion.
- Non-transitional cell histology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Evaluation of Robotic-assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder
The goal of this clinical research study is to evaluate how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made, in patients who are having their bladder removed for the treatment of bladder cancer.
The primary objective is to compare the lymph node yield achieved by performing a robotic-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) compared to a second-look open lymph node dissection (O-PLND) among patients undergoing radical cystectomy for transitional cell carcinoma of the bladder.
The secondary objectives will be to collect prospective outcomes data related to the performance of RA-PLND and robotic-assisted cystectomy (RA-C) including operative times, estimated blood loss, transfusions, complications, return to diet, utilization of pain medication, hospital length, return to regular activities.
Read the detailed description
Study Background:
Research has shown that the more lymph nodes removed as part of a radical cystectomy (bladder removal) for invasive bladder cancer, the better. However, the number of lymph nodes removed varies from person to person. The standard surgical techniques such as robot-assisted procedures are new, and researchers want to be able to more reliably tell if the specific number of lymph nodes removed is enough to be considered a "complete" removal.
In this study, researchers will remove the required lymph nodes using a standard robotic-assisted procedure, and then remove any additional lymph nodes that remain and need to be removed, using a wider ("open") incision in the abdomen. This open technique is also being done for standard of care. It is needed in order to complete the "urinary diversion" part of the surgery (a procedure of surgically making way for urine to pass out of the body so that it does not go through the bladder).
The main goal of the study is to see if the robotic-assisted procedure removes all of the required lymph nodes. The open technique will allow researchers to evaluate how many lymph nodes were left behind after robotic-assisted removal.
It is possible that the machine may have problems and not be available for use on the scheduled day of surgery. If that happens, you will have the option to reschedule surgery or have standard open surgery. It is also possible that the machine could have problems during your surgery. If that happens, your doctor will continue with standard open surgery. Your study doctor will discuss these possible situations with you.
You will be asked to sign a separate consent form for these surgical procedures, which will describe the procedures and their risks in more detail.
Follow-up:
You will be asked to fill out a brief pain survey once a week for 7 weeks after surgery. The survey will take about 5 minutes to complete. You will also be given a diary to record your daily pain medication use. It will also take about 5 minutes to complete. You will continue to complete the questionnaire once a week and to fill out the diary daily for 6 weeks.
End-of-Study Visit:
You will visit the clinic 6-12 weeks after surgery for an end-of-study visit. You will have a chest x-ray. Your pain medication use and pain level surveys will be collected. After this visit, you will be off-study.
This is an investigational study. The robotic-assisted bladder removal is FDA approved for this purpose. Up to 60 patients will be enrolled in this study. All will be enrolled at The University of Texas (UT) MD Anderson Cancer Center (MDACC).
- Conditions
- Bladder Cancer
- Being tested
- Robotic-assisted laparoscopic surgery
- Keywords
- Robotic-assisted laparoscopic surgery, Extended pelvic lymph node dissection, RA-PLND, Second-look open lymph node dissection, O-PLND, Radical Cystectomy, Urinary diversion, Bladder
- 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.
Robotic-assisted laparoscopic surgeryProcedure or surgery
During radical cystectomy, robotic-assisted technique used to perform cystectomy and pelvic lymph node dissections. Each patient will undergo a second-look open lymph node dissection once the incision is made at the end for the urinary diversion.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted laparoscopic surgery | Experimental | Robotic-assisted laparoscopic extended pelvic lymph node dissection Receives: Procedure: Robotic-assisted laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Yield of Robot Assisted and Second Look Open Pelvic Lymph Node Dissection to Compare the Lymph Node Yield Achieved
The median yield (the lymph node count) allows for comparison of how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made. Specifically a robot-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) is compared to a second-look open lymph node dissection (O-PLND) among participants undergoing radical cystectomy for urothelial carcinoma of the bladder. The median yield lymph nodes illustrate the adequacy of extended pelvic lymph node dissection using a robotic-assisted technique, i.e. whether the robotic-assisted laparoscopic radical cystectomy yields a sufficient number of lymph nodes to be oncologically equivalent to the open procedure.
Measured: 3 months including surgery and post-operative period.
Overall Percentage Median Yield
The median yield (the lymph node count) allows for comparison of how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made. Specifically a robot-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) is compared to a second-look open lymph node dissection (O-PLND) among participants undergoing radical cystectomy for urothelial carcinoma of the bladder. The median yield lymph nodes illustrates the adequacy of extended pelvic lymph node dissection using a robotic-assisted technique.
Measured: 3 months including surgery and post-operative period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study startOct 2007
- Primary completionJun 2011
- Study completionJun 2011
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 (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 M.D. Anderson 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John W. Davis, MD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963859
- Sponsor's protocol ID
- 2007-0441
- Status last verified
- Apr 2013
- First submitted
- 19 Aug 2009
- Last updated
- 21 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Davis JW, Gaston K, Anderson R, Dinney CP, Grossman HB, Munsell MF, Kamat AM. Robot assisted extended pelvic lymphadenectomy at radical cystectomy: lymph node yield compared with second look open dissection. J Urol. 2011 Jan;185(1):79-83. doi: 10.1016/j.juro.2010.09.031. Epub 2010 Nov 12.
PubMed 21074799
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation of Robotic-assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder
- ClinicalTrials.gov ID
- NCT00963859
- Acronym / sponsor ID
- 2007-0441
- Conditions
- Bladder Cancer
- Keywords
- Robotic-assisted laparoscopic surgery, Extended pelvic lymph node dissection, RA-PLND, Second-look open lymph node dissection, O-PLND, Radical Cystectomy, Urinary diversion, Bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Aug 2009 (estimated)
- Results
- Posted 21 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to evaluate how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made, in patients who are having their bladder removed for the treatment of bladder cancer.
The primary objective is to compare the lymph node yield achieved by performing a robotic-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) compared to a second-look open lymph node dissection (O-PLND) among patients undergoing radical cystectomy for transitional cell carcinoma of the bladder.
The secondary objectives will be to collect prospective outcomes data related to the performance of RA-PLND and robotic-assisted cystectomy (RA-C) including operative times, estimated blood loss, transfusions, complications, return to diet, utilization of pain medication, hospital length, return to regular activities.
Detailed description
Study Background:
Research has shown that the more lymph nodes removed as part of a radical cystectomy (bladder removal) for invasive bladder cancer, the better. However, the number of lymph nodes removed varies from person to person. The standard surgical techniques such as robot-assisted procedures are new, and researchers want to be able to more reliably tell if the specific number of lymph nodes removed is enough to be considered a "complete" removal.
In this study, researchers will remove the required lymph nodes using a standard robotic-assisted procedure, and then remove any additional lymph nodes that remain and need to be removed, using a wider ("open") incision in the abdomen. This open technique is also being done for standard of care. It is needed in order to complete the "urinary diversion" part of the surgery (a procedure of surgically making way for urine to pass out of the body so that it does not go through the bladder).
The main goal of the study is to see if the robotic-assisted procedure removes all of the required lymph nodes. The open technique will allow researchers to evaluate how many lymph nodes were left behind after robotic-assisted removal.
It is possible that the machine may have problems and not be available for use on the scheduled day of surgery. If that happens, you will have the option to reschedule surgery or have standard open surgery. It is also possible that the machine could have problems during your surgery. If that happens, your doctor will continue with standard open surgery. Your study doctor will discuss these possible situations with you.
You will be asked to sign a separate consent form for these surgical procedures, which will describe the procedures and their risks in more detail.
Follow-up:
You will be asked to fill out a brief pain survey once a week for 7 weeks after surgery. The survey will take about 5 minutes to complete. You will also be given a diary to record your daily pain medication use. It will also take about 5 minutes to complete. You will continue to complete the questionnaire once a week and to fill out the diary daily for 6 weeks.
End-of-Study Visit:
You will visit the clinic 6-12 weeks after surgery for an end-of-study visit. You will have a chest x-ray. Your pain medication use and pain level surveys will be collected. After this visit, you will be off-study.
This is an investigational study. The robotic-assisted bladder removal is FDA approved for this purpose. Up to 60 patients will be enrolled in this study. All will be enrolled at The University of Texas (UT) MD Anderson Cancer Center (MDACC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted laparoscopic surgery | Experimental | Procedure: Robotic-assisted laparoscopic surgeryRobotic-assisted laparoscopic extended pelvic lymph node dissection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are eligible for a radical cystectomy and who, in the opinion of the treating MDACC physician, are candidates for a robotic-assisted laparoscopic technique for management of the bladder and lymph nodes.
- Diagnosis of transitional cell carcinoma of the bladder.
- Medical fitness for open radical cystectomy by consensus of MDACC urology and anesthesia faculty (medicine/cardiology clearance by common best practice criteria).
- Staging inclusion by cystoscopic biopsy and bimanual examination under anesthesia: carcinoma in-situ, T1, T2.
Key exclusion criteria (4 listed)
- Prior pelvic radiation.
- Morbid obesity, i.e., body mass index (BMI)> 35.
- Metastatic disease, bulky disease--T3a/b, prostatic stromal invasion.
- Non-transitional cell histology.
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 |
|---|---|---|
| Robotic-assisted laparoscopic surgeryDuring radical cystectomy, robotic-assisted technique used to perform cystectomy and pelvic lymph node dissections. Each patient will undergo a second-look open lymph node dissection once the incision is made at the end for the urinary diversion. | Procedure or surgery | Robotic-assisted laparoscopic surgery |
Primary outcome
Median Yield of Robot Assisted and Second Look Open Pelvic Lymph Node Dissection to Compare the Lymph Node Yield Achieved
Time frame: 3 months including surgery and post-operative period.
The median yield (the lymph node count) allows for comparison of how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made. Specifically a robot-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) is compared to a second-look open lymph node dissection (O-PLND) among participants undergoing radical cystectomy for urothelial carcinoma of the bladder. The median yield lymph nodes illustrate the adequacy of extended pelvic lymph node dissection using a robotic-assisted technique, i.e. whether the robotic-assisted laparoscopic radical cystectomy yields a sufficient number of lymph nodes to be oncologically equivalent to the open procedure.
Overall Percentage Median Yield
Time frame: 3 months including surgery and post-operative period.
The median yield (the lymph node count) allows for comparison of how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made. Specifically a robot-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) is compared to a second-look open lymph node dissection (O-PLND) among participants undergoing radical cystectomy for urothelial carcinoma of the bladder. The median yield lymph nodes illustrates the adequacy of extended pelvic lymph node dissection using a robotic-assisted technique.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21074799Davis JW, Gaston K, Anderson R, Dinney CP, Grossman HB, Munsell MF, Kamat AM. Robot assisted extended pelvic lymphadenectomy at radical cystectomy: lymph node yield compared with second look open dissection. J Urol. 2011 Jan;185(1):79-83. doi: 10.1016/j.juro.2010.09.031. Epub 2010 Nov 12.
- UT MD Anderson Cancer Center websiteLink 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.
John W. Davis, MD study chair
UT MD Anderson 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 2 study testing Robotic-assisted laparoscopic surgery in people with Bladder Cancer, run by M.D. Anderson 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 4 inclusion and 4 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 21 May 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2013). 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?
Median Yield of Robot Assisted and Second Look Open Pelvic Lymph Node Dissection to Compare the Lymph Node Yield Achieved (time frame: 3 months including surgery and post-operative period.). The study lists 2 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 NCT00963859, 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 21 May 2013.