Bladder CancerPhase 2OvsLNCT02345499
Open Versus Laparoscopic Radical Cystectomy
A Phase 2 study testing Laparoscopic radical cystectomy with open urinary diversion and Open radical cystectomy with open urinary diversion in people with Bladder Cancer, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial summary
To date, no trials have been designed to compare open Vs laparoscopic radical cystectomy in the elderly patients, both in terms of functional and clinical outcome measures. A more meaningful comparison of the two modalities is that of a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 70 years and older, men only
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Laparoscopic radical cystectomy with open urinary diversion and Open radical cystectomy with open urinary diversion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Jan 2016
- Phase
- Phase 2
- 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 70 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with a histologically proven diagnosis of transitional cell carcinoma of the bladder
- Patients with an indication to ureterocutaneostomy or ileal conduit
- ECOG Performance Status ≤ 2
- WBC count ≥4,000/μL; platelet count ≥150,000/μL
- 4.Recent (within 6 weeks of cystectomy) total body CT imaging study excluding distant metastases as well as upper urinary tract TCC
Who cannot join
- Patients who have previously undergone lower abdominal and/or pelvic surgery for invasive cancer (i.e. radical prostatectomy, large bowel surgeries with or without ileal/colonic conduit)
- Patients who have previously received any pelvic irradiation
- Patients with a synchronous upper urinary tract malignancy requiring a nephroureterectomy concomitant to cystectomy
- Patients candidates for a palliative cystectomy (i.e. recurrent haematuria which cannot be treated by endoscopy)
- Patients with a histologically proven diagnosis of bladder adenocarcinoma, squamous cell carcinoma, and small cell carcinoma
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Vincenzo Pagliarulo
Bari, Italy, 70124
Vincenzo VP Pagliarulo, Urologist, + 39 080 559 5228, vpagliarulo@urologia.uniba.it
Vincenzo VP Pagliarulo, Urologist, +39 080 559 5228, vpagliarulo@urologia.uniba.it
About this study
Official title: Open Versus Laparoscopic Radical Cystectomy for Invasive Bladder Cancer in the Elderly Patient. A Multicenter Randomized Clinical Trial.
To date, no trials have been designed to compare open Vs laparoscopic radical cystectomy in the elderly patients, both in terms of functional and clinical outcome measures. A more meaningful comparison of the two modalities is that of a randomized controlled trial.
- Conditions
- Bladder Cancer
- Being tested
- Laparoscopic radical cystectomy with open urinary diversion, Open radical cystectomy with open urinary diversion
- Keywords
- Radical cystectomy, Laparoscopy
- 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.
Laparoscopic radical cystectomy with open urinary diversionProcedure or surgery
Laparoscopic surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed
Open radical cystectomy with open urinary diversionProcedure or surgery
Open surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic radical cystectomy | Experimental | Surgery: Laparoscopic radical cystectomy with open urinary diversion Receives: Procedure: Laparoscopic radical cystectomy with open urinary diversion |
| Open radical cystectomy | Active comparator | Surgery: Open radical cystectomy with open urinary diversion Receives: Procedure: Open radical cystectomy with open urinary diversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
Comparison of the complication rate among the two cohorts of patients under investigation according to the Clavien classification.
Measured: 24 months
Secondary outcomes (1)
Health related quality of life
Comparison of health related quality of life among the two cohorts under investigation according to the SF-36 questionnaire
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2014
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pagliarulo Vincenzo, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Investigators
- Vincenzo VP Pagliarulo, M.D., Principal investigator, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345499
- Sponsor's protocol ID
- 4201
- Acronym
- OvsL
- Status last verified
- Jan 2015
- First submitted
- 14 Jan 2015
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Haber GP, Crouzet S, Gill IS. Laparoscopic and robotic assisted radical cystectomy for bladder cancer: a critical analysis. Eur Urol. 2008 Jul;54(1):54-62. doi: 10.1016/j.eururo.2008.03.076. Epub 2008 Apr 1.
PubMed 18403100Hemal AK. Robotic and laparoscopic radical cystectomy in the management of bladder cancer. Curr Urol Rep. 2009 Jan;10(1):45-54. doi: 10.1007/s11934-009-0009-8.
PubMed 19116095Edwards BK, Howe HL, Ries LA, Thun MJ, Rosenberg HM, Yancik R, Wingo PA, Jemal A, Feigal EG. Annual report to the nation on the status of cancer, 1973-1999, featuring implications of age and aging on U.S. cancer burden. Cancer. 2002 May 15;94(10):2766-92. doi: 10.1002/cncr.10593.
PubMed 12173348Chamie K, Hu B, Devere White RW, Ellison LM. Cystectomy in the elderly: does the survival benefit in younger patients translate to the octogenarians? BJU Int. 2008 Aug;102(3):284-90. doi: 10.1111/j.1464-410X.2008.07636.x. Epub 2008 Apr 11.
PubMed 18410437Nielsen ME, Shariat SF, Karakiewicz PI, Lotan Y, Rogers CG, Amiel GE, Bastian PJ, Vazina A, Gupta A, Lerner SP, Sagalowsky AI, Schoenberg MP, Palapattu GS; Bladder Cancer Research Consortium (BCRC). Advanced age is associated with poorer bladder cancer-specific survival in patients treated with radical cystectomy. Eur Urol. 2007 Mar;51(3):699-706; discussion 706-8. doi: 10.1016/j.eururo.2006.11.004. Epub 2006 Nov 13.
PubMed 17113703Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
PubMed 3558716
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Versus Laparoscopic Radical Cystectomy for Invasive Bladder Cancer in the Elderly Patient. A Multicenter Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02345499
- Acronym / sponsor ID
- OvsL / 4201
- Conditions
- Bladder Cancer
- Keywords
- Radical cystectomy, Laparoscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 26 Jan 2015 (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.
To date, no trials have been designed to compare open Vs laparoscopic radical cystectomy in the elderly patients, both in terms of functional and clinical outcome measures. A more meaningful comparison of the two modalities is that of a randomized controlled trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic radical cystectomy | Experimental | Procedure: Laparoscopic radical cystectomy with open urinary diversionSurgery: Laparoscopic radical cystectomy with open urinary diversion |
| Open radical cystectomy | Active comparator | Procedure: Open radical cystectomy with open urinary diversionSurgery: Open radical cystectomy with open urinary diversion |
Who may qualify
- Ages
- 70 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients with a histologically proven diagnosis of transitional cell carcinoma of the bladder
- Patients with an indication to ureterocutaneostomy or ileal conduit
- ECOG Performance Status ≤ 2
- WBC count ≥4,000/μL; platelet count ≥150,000/μL
- 4.Recent (within 6 weeks of cystectomy) total body CT imaging study excluding distant metastases as well as upper urinary tract TCC
Key exclusion criteria (5 listed)
- Patients who have previously undergone lower abdominal and/or pelvic surgery for invasive cancer (i.e. radical prostatectomy, large bowel surgeries with or without ileal/colonic conduit)
- Patients who have previously received any pelvic irradiation
- Patients with a synchronous upper urinary tract malignancy requiring a nephroureterectomy concomitant to cystectomy
- Patients candidates for a palliative cystectomy (i.e. recurrent haematuria which cannot be treated by endoscopy)
- Patients with a histologically proven diagnosis of bladder adenocarcinoma, squamous cell carcinoma, and small cell carcinoma
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 |
|---|---|---|
| Laparoscopic radical cystectomy with open urinary diversionLaparoscopic surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed | Procedure or surgery | Laparoscopic radical cystectomy |
| Open radical cystectomy with open urinary diversionOpen surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed | Procedure or surgery | Open radical cystectomy |
Primary outcome
Complication rate
Time frame: 24 months
Comparison of the complication rate among the two cohorts of patients under investigation according to the Clavien classification.
1 secondary outcome
Health related quality of life
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Background: PubMed 18403100Haber GP, Crouzet S, Gill IS. Laparoscopic and robotic assisted radical cystectomy for bladder cancer: a critical analysis. Eur Urol. 2008 Jul;54(1):54-62. doi: 10.1016/j.eururo.2008.03.076. Epub 2008 Apr 1.
- Background: PubMed 19116095Hemal AK. Robotic and laparoscopic radical cystectomy in the management of bladder cancer. Curr Urol Rep. 2009 Jan;10(1):45-54. doi: 10.1007/s11934-009-0009-8.
- Background: PubMed 12173348Edwards BK, Howe HL, Ries LA, Thun MJ, Rosenberg HM, Yancik R, Wingo PA, Jemal A, Feigal EG. Annual report to the nation on the status of cancer, 1973-1999, featuring implications of age and aging on U.S. cancer burden. Cancer. 2002 May 15;94(10):2766-92. doi: 10.1002/cncr.10593.
- Background: PubMed 18410437Chamie K, Hu B, Devere White RW, Ellison LM. Cystectomy in the elderly: does the survival benefit in younger patients translate to the octogenarians? BJU Int. 2008 Aug;102(3):284-90. doi: 10.1111/j.1464-410X.2008.07636.x. Epub 2008 Apr 11.
- Background: PubMed 17113703Nielsen ME, Shariat SF, Karakiewicz PI, Lotan Y, Rogers CG, Amiel GE, Bastian PJ, Vazina A, Gupta A, Lerner SP, Sagalowsky AI, Schoenberg MP, Palapattu GS; Bladder Cancer Research Consortium (BCRC). Advanced age is associated with poorer bladder cancer-specific survival in patients treated with radical cystectomy. Eur Urol. 2007 Mar;51(3):699-706; discussion 706-8. doi: 10.1016/j.eururo.2006.11.004. Epub 2006 Nov 13.
- Background: PubMed 3558716Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
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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.
Vincenzo VP Pagliarulo, M.D. principal investigator
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
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 Laparoscopic radical cystectomy with open urinary diversion and Open radical cystectomy with open urinary diversion in people with Bladder Cancer, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
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 5 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: status not confirmed, as of the sponsor's last update on 26 Jan 2015. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo VP Pagliarulo, M.D. (+39 080 5595228, vpagliarulo@urologia.uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate (time frame: 24 months). 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 NCT02345499, which also lists 6 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 26 Jan 2015.