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

Phase 2

• Conditions: Bladder Cancer

• Registration Number: NCT01196403
• Lead Sponsor: Wales Cancer Trials Unit

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.

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 Timeline

• Study Start: 2009-01
• Status Verified: 2010-09
• Study First Submitted: 2010-09-04
• Study First Submitted QC: 2010-09-04
• Study First Posted: 2010-09-08
• Primary Completion: 2010-12
• Last Update Submitted: 2011-03-31
• Last Update Posted: 2011-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients who consent to be randomized

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (4)

Wales Cancer Trials Unit; 🇬🇧 Cardiff, Wales, United Kingdom

Addenbrooke's Hospital; 🇬🇧 Cambridge, England, United Kingdom

University College of London Hospitals; 🇬🇧 London, England, United Kingdom

Guy's Hospital; 🇬🇧 London, England, United Kingdom