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

March 31, 2011 updated by: Wales Cancer Trials Unit

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Cambridge, England, United Kingdom, CB2 0QQ
        • Recruiting
        • Addenbrooke's Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1223-245-151
      • London, England, United Kingdom, WC1E 6AU
        • Recruiting
        • University College of London Hospitals
        • Contact:
      • London, England, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-20-7188-7188
    • Wales
      • Cardiff, Wales, United Kingdom, CF11 9LJ
        • Recruiting
        • Wales Cancer Trials Unit
        • Contact:
          • Contact Person
          • Phone Number: 44-29-2019-6800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percentage of patients who consent to be randomized

Secondary Outcome Measures

Outcome Measure
Safety and efficacy
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
Quality of life data measuring return to normal activities (physical, social, and occupational)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wales Cancer Trials Unit

Investigators

  • Principal Investigator: John Kelly, MD, University College London Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

September 4, 2010

First Submitted That Met QC Criteria

September 4, 2010

First Posted (Estimate)

September 8, 2010

Study Record Updates

Last Update Posted (Estimate)

April 1, 2011

Last Update Submitted That Met QC Criteria

March 31, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000684060
  • WCTU-BOLERO
  • ISRCTN-38528926
  • EU-21069
  • CRUK-08/036
  • WCTU-SPON-568-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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