Status:
UNKNOWN
Standard Surgery or Minimal-Access Surgery in Treating Patients With Bladder Cancer
Lead Sponsor:
Wales Cancer Trials Unit
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 m...
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). ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01196403
Start Date
January 1 2009
Last Update
April 1 2011
Active Locations (4)
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1
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 0QQ
2
Guy's Hospital
London, England, United Kingdom, SE1 9RT
3
University College of London Hospitals
London, England, United Kingdom, WC1E 6AU
4
Wales Cancer Trials Unit
Cardiff, Wales, United Kingdom, CF11 9LJ