Standard Surgery or Minimal-Access Surgery in Treating Patients With Bladder Cancer
Recruitment status was: Recruiting
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.
Other: questionnaire administration
Procedure: quality-of-life assessment
Procedure: robot-assisted laparoscopic surgery
Procedure: therapeutic conventional surgery
Procedure: therapeutic laparoscopic surgery
|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.|
- Percentage of patients who consent to be randomized [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||January 2009|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196403
|Cambridge, England, United Kingdom, CB2 0QQ|
|London, England, United Kingdom, SE1 9RT|
|University College of London Hospitals|
|London, England, United Kingdom, WC1E 6AU|
|Wales Cancer Trials Unit|
|Cardiff, Wales, United Kingdom, CF11 9LJ|
|Principal Investigator:||John Kelly, MD||University College London Hospitals|