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

Wales Cancer Trials Unit

Status and phase: Unknown; Phase 2

Conditions: Bladder Cancer

Treatments: Other: questionnaire administration; Procedure: robot-assisted laparoscopic surgery; Procedure: quality-of-life assessment; Procedure: therapeutic conventional surgery; Procedure: therapeutic laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01196403

WCTU-SPON-568-08

CRUK-08/036

ISRCTN-38528926

EU-21069

CDR0000684060

WCTU-BOLERO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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