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

Bladder Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01196403
• Other study ID #: CDR0000684060
• Secondary ID: WCTU-BOLEROISRCT
• Status: Recruiting
• Phase: Phase 2
• First received: September 4, 2010
• Last updated: March 31, 2011
• Start date: January 2009

Study information

• Verified date: September 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Other:
• questionnaire administration

Procedure:
• quality-of-life assessment

• robot-assisted laparoscopic surgery

• therapeutic conventional surgery

• therapeutic laparoscopic surgery

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Wales Cancer Trials Unit	Cardiff	Wales
United Kingdom	Guy's Hospital	London	England
United Kingdom	University College of London Hospitals	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Wales Cancer Trials Unit

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who consent to be randomized			No
Secondary	Potential barriers to randomization via semistructured qualitative interviews with patients who consent to registration and do not accept randomization			No
Secondary	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			No
Secondary	Safety and efficacy			Yes
Secondary	Quality of life data measuring return to normal activities (physical, social, and occupational)			No