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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01196403
First received: September 4, 2010
Last updated: March 31, 2011
Last verified: September 2010
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Percentage of patients who consent to be randomized [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Potential barriers to randomization via semistructured qualitative interviews with patients who consent to registration and do not accept randomization [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Safety and efficacy [ Designated as safety issue: Yes ]
  • Quality of life data measuring return to normal activities (physical, social, and occupational) [ Designated as safety issue: No ]

Estimated Enrollment: 92
Study Start Date: January 2009
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196403

Locations
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    j.d.kelly@ucl.ac.uk   
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
Investigators
Principal Investigator: John Kelly, MD University College London Hospitals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01196403     History of Changes
Other Study ID Numbers: CDR0000684060, WCTU-BOLERO, ISRCTN-38528926, EU-21069, CRUK-08/036, WCTU-SPON-568-08
Study First Received: September 4, 2010
Last Updated: March 31, 2011
Health Authority: Unspecified

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:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 28, 2014