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.
18 Years
N/A
Both
Bladder Cancer
Trial Information
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.
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of patients who consent to be randomized
Safety Issue:
No
Principal Investigator
John Kelly, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University College London Hospitals
Authority:
Unspecified
Study ID:
CDR0000684060
NCT ID:
NCT01196403
Start Date:
January 2009
Completion Date:
Related Keywords:
- Bladder Cancer
- transitional cell carcinoma of the bladder
- squamous cell carcinoma of the bladder
- adenocarcinoma of the bladder
- stage I bladder cancer
- stage II bladder cancer
- stage III bladder cancer
- Urinary Bladder Neoplasms
Name | Location |
|---|
