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Standard Surgery or Minimal-Access Surgery in Treating Patients With Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01196403
Recruitment Status : Unknown
Verified September 2010 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : September 8, 2010
Last Update Posted : April 1, 2011
Information provided by:
National Cancer Institute (NCI)

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Other: questionnaire administration Procedure: quality-of-life assessment Procedure: robot-assisted laparoscopic surgery Procedure: therapeutic conventional surgery Procedure: therapeutic laparoscopic surgery Phase 2

Detailed Description:



  • To determine the feasibility of randomizing patients with bladder cancer to undergo an open cystectomy versus a minimal-access cystectomy (laparoscopic or robotic cystectomy).


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : January 2009
Estimated Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Primary Outcome Measures :
  1. Percentage of patients who consent to be randomized

Secondary Outcome Measures :
  1. Potential barriers to randomization via semistructured qualitative interviews with patients who consent to registration and do not accept randomization
  2. 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
  3. Safety and efficacy
  4. Quality of life data measuring return to normal activities (physical, social, and occupational)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01196403

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United Kingdom
Addenbrooke's Hospital Recruiting
Cambridge, England, United Kingdom, CB2 0QQ
Contact: Contact Person    44-1223-245-151      
Guy's Hospital Recruiting
London, England, United Kingdom, SE1 9RT
Contact: Contact Person    44-20-7188-7188      
University College of London Hospitals Recruiting
London, England, United Kingdom, WC1E 6AU
Contact: Contact Person    44-20-3108-2050   
Wales Cancer Trials Unit Recruiting
Cardiff, Wales, United Kingdom, CF11 9LJ
Contact: Contact Person    44-29-2019-6800      
Sponsors and Collaborators
Wales Cancer Trials Unit
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Principal Investigator: John Kelly, MD University College London Hospitals
Layout table for additonal information Identifier: NCT01196403    
Other Study ID Numbers: CDR0000684060
First Posted: September 8, 2010    Key Record Dates
Last Update Posted: April 1, 2011
Last Verified: September 2010
Keywords provided by National Cancer Institute (NCI):
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
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases