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.|
|ClinicalTrials.gov 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
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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Masking:||None (Open Label)|
|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|
- Percentage of patients who consent to be randomized
- 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)
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 ClinicalTrials.gov identifier (NCT number): NCT01196403
|Cambridge, England, United Kingdom, CB2 0QQ|
|Contact: Contact Person 44-1223-245-151|
|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 firstname.lastname@example.org|
|Wales Cancer Trials Unit||Recruiting|
|Cardiff, Wales, United Kingdom, CF11 9LJ|
|Contact: Contact Person 44-29-2019-6800|
|Principal Investigator:||John Kelly, MD||University College London Hospitals|