Bladder CancerPhase 2NCT01196403
Standard Surgery or Minimal-Access Surgery in Treating Patients With Bladder Cancer
A Phase 2 study testing questionnaire administration, quality-of-life assessment and robot-assisted laparoscopic surgery in people with Bladder Cancer, run by Wales Cancer Trials Unit at 4 sites in United Kingdom.
Trial summary
RATIONALE: Minimal-access surgery uses a smaller opening in the body to remove the tumor than is used in standard surgery. It is not yet known whether minimal-access surgery to remove the bladder is more effective than standard surgery to remove the bladder in treating patients with bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- questionnaire administration, quality-of-life assessment and robot-assisted laparoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 92 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Jan 2009to Dec 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histopathologically confirmed bladder cancer, including any of the following cell types:
- Urothelial cell (transitional cell) carcinoma
- Squamous cell carcinoma
- Adenocarcinoma
- Stage pT1, pT2, or pT3 disease OR mobile bladder mass on bimanual examination under anesthesia
- No enlarged nodes or distant metastases on CT or MRI scan of the abdomen and pelvis
- No upper urinary tract disease
PATIENT CHARACTERISTICS:
- American Society of Anesthesiologist (ASA) status 1-3
- Life expectancy > 24 months
- Not pregnant or nursing
- Negative pregnancy test
- No concurrent disease that would render the patient unsuitable for the trial
- No presence of urosepsis
PRIOR CONCURRENT THERAPY:
- May have received prior neoadjuvant chemotherapy provided study surgery is performed between 3 and 10 weeks from the date of the completion of chemotherapy treatment
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites, 4 recruiting
- Recruiting
Addenbrooke's Hospital
Cambridge, England, CB2 0QQ
Contact Person, 44-1223-245-151
- Recruiting
Wales Cancer Trials Unit
Cardiff, Wales, CF11 9LJ
Contact Person, 44-29-2019-6800
- Recruiting
Guy's Hospital
London, England, SE1 9RT
Contact Person, 44-20-7188-7188
- Recruiting
University College of London Hospitals
London, England, WC1E 6AU
Contact Person, 44-20-3108-2050, j.d.kelly@ucl.ac.uk
About this study
Official title: Bladder Cancer: Open Versus Laparoscopic or Robotic Cystectomy. A Study to Determine the Feasibility of Randomization to Open Versus Minimal Access Cystectomy in Patients With Bladder Cancer.
RATIONALE: Minimal-access surgery uses a smaller opening in the body to remove the tumor than is used in standard surgery. It is not yet known whether minimal-access surgery to remove the bladder is more effective than standard surgery to remove the bladder in treating patients with bladder cancer.
PURPOSE: This randomized phase II trial is studying standard surgery to see how well it works compared with minimal-access surgery in treating patients with bladder cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the feasibility of randomizing patients with bladder cancer to undergo an open cystectomy versus a minimal-access cystectomy (laparoscopic or robotic cystectomy).
Secondary
- To assess the safety and efficacy of laparoscopic or robotic cystectomy and the reasons for non-acceptance of randomization.
- To collect safety and toxicity data, including measures of postoperative morbidity and surgical complications. (Exploratory)
- To investigate anatomical lymph node dissection (an indicator for oncological clearance) and completeness of cancer surgery. (Exploratory)
- To determine the quality of life of these patients using EORTC QLQ-C30 and EORTC QLQ-BLM30 questionnaires. (Exploratory)
OUTLINE: This is a multicenter study. Patients who consent to the interview-only (but not randomization) undergo a qualitative interview exploring factors relating to this decision. Patients who consent to randomization are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo an open radical cystectomy.
- Arm II: Patients undergo a minimal-access radical cystectomy (laparoscopic or robotic).
Patients complete quality-of-life questionnaires (EORTC QLQ-C30 and EORTC QLQ-BLM30) at baseline and at 4 weeks, 6 weeks, 8 weeks, 3 months, and 6 months after completion of study therapy. Blood, urine, and tissue samples are collected from some patients at baseline and during study for laboratory analysis.
After completion of study treatment, patients are followed up at 6 weeks, 3 months, and 6 months.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
PROJECTED ACCRUAL: A total of 92 patients (72 patients for the randomized portion and 20 for the interview-only portion) are accrued for this study.
- Conditions
- Bladder Cancer
- Being tested
- questionnaire administration, quality-of-life assessment, robot-assisted laparoscopic surgery, therapeutic conventional surgery, therapeutic laparoscopic surgery
- Keywords
- transitional cell carcinoma of the bladder, squamous cell carcinoma of the bladder, adenocarcinoma of the bladder, stage I bladder cancer, stage II bladder cancer, stage III 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.
questionnaire administrationOther
quality-of-life assessmentProcedure or surgery
robot-assisted laparoscopic surgeryProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
therapeutic laparoscopic surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who consent to be randomized
Secondary outcomes (4)
Potential barriers to randomization via semistructured qualitative interviews with patients who consent to registration and do not accept randomization
Potential factors relating to non-registration of patients who are eligible for inclusion but have not been registered based on review of anonymous screening logs
Safety and efficacy
Quality of life data measuring return to normal activities (physical, social, and occupational)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startJan 2009
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wales Cancer Trials Unit
- Sponsor type
- University, hospital or other
- Investigators
- John Kelly, MD, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196403
- Sponsor's protocol ID
- CDR0000684060
- Other IDs
- WCTU-BOLERO, ISRCTN-38528926, EU-21069, CRUK-08/036, WCTU-SPON-568-08
- Status last verified
- Sep 2010
- First submitted
- 4 Sep 2010
- Last updated
- 1 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Cancer: Open Versus Laparoscopic or Robotic Cystectomy. A Study to Determine the Feasibility of Randomization to Open Versus Minimal Access Cystectomy in Patients With Bladder Cancer.
- ClinicalTrials.gov ID
- NCT01196403
- Acronym / sponsor ID
- CDR0000684060
- Conditions
- Bladder Cancer
- Keywords
- transitional cell carcinoma of the bladder, squamous cell carcinoma of the bladder, adenocarcinoma of the bladder, stage I bladder cancer, stage II bladder cancer, stage III bladder cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Wales Cancer Trials UnitUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (estimated)
- First posted
- 8 Sep 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.
RATIONALE: Minimal-access surgery uses a smaller opening in the body to remove the tumor than is used in standard surgery. It is not yet known whether minimal-access surgery to remove the bladder is more effective than standard surgery to remove the bladder in treating patients with bladder cancer.
PURPOSE: This randomized phase II trial is studying standard surgery to see how well it works compared with minimal-access surgery in treating patients with bladder cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the feasibility of randomizing patients with bladder cancer to undergo an open cystectomy versus a minimal-access cystectomy (laparoscopic or robotic cystectomy).
Secondary
- To assess the safety and efficacy of laparoscopic or robotic cystectomy and the reasons for non-acceptance of randomization.
- To collect safety and toxicity data, including measures of postoperative morbidity and surgical complications. (Exploratory)
- To investigate anatomical lymph node dissection (an indicator for oncological clearance) and completeness of cancer surgery. (Exploratory)
- To determine the quality of life of these patients using EORTC QLQ-C30 and EORTC QLQ-BLM30 questionnaires. (Exploratory)
OUTLINE: This is a multicenter study. Patients who consent to the interview-only (but not randomization) undergo a qualitative interview exploring factors relating to this decision. Patients who consent to randomization are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo an open radical cystectomy.
- Arm II: Patients undergo a minimal-access radical cystectomy (laparoscopic or robotic).
Patients complete quality-of-life questionnaires (EORTC QLQ-C30 and EORTC QLQ-BLM30) at baseline and at 4 weeks, 6 weeks, 8 weeks, 3 months, and 6 months after completion of study therapy. Blood, urine, and tissue samples are collected from some patients at baseline and during study for laboratory analysis.
After completion of study treatment, patients are followed up at 6 weeks, 3 months, and 6 months.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
PROJECTED ACCRUAL: A total of 92 patients (72 patients for the randomized portion and 20 for the interview-only portion) are accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| questionnaire administration | Other | – |
| quality-of-life assessment | Procedure or surgery | – |
| robot-assisted laparoscopic surgery | Procedure or surgery | – |
| therapeutic conventional surgery | Procedure or surgery | – |
| therapeutic laparoscopic surgery | Procedure or surgery | – |
Primary outcome
Percentage of patients who consent to be randomized
4 secondary outcomes
Potential barriers to randomization via semistructured qualitative interviews with patients who consent to registration and do not accept randomization
Potential factors relating to non-registration of patients who are eligible for inclusion but have not been registered based on review of anonymous screening logs
Safety and efficacy
Quality of life data measuring return to normal activities (physical, social, and occupational)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2011.
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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 Kelly, MD principal investigator
University College London Hospitals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing questionnaire administration, quality-of-life assessment and robot-assisted laparoscopic surgery in people with Bladder Cancer, run by Wales Cancer Trials Unit at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who consent to be randomized. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2011.