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Trial Title:
Standard Surgery or Minimal-Access Surgery in Treating Patients With Bladder Cancer
NCT ID:
NCT01196403
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
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
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
questionnaire administration
Intervention type:
Procedure
Intervention name:
quality-of-life assessment
Intervention type:
Procedure
Intervention name:
robot-assisted laparoscopic surgery
Intervention type:
Procedure
Intervention name:
therapeutic conventional surgery
Intervention type:
Procedure
Intervention name:
therapeutic laparoscopic surgery
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Addenbrooke's Hospital
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Contact Person
Phone:
44-1223-245-151
Facility:
Name:
Guy's Hospital
Address:
City:
London
Zip:
SE1 9RT
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Contact Person
Phone:
44-20-7188-7188
Facility:
Name:
University College of London Hospitals
Address:
City:
London
Zip:
WC1E 6AU
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Contact Person
Phone:
44-20-3108-2050
Email:
j.d.kelly@ucl.ac.uk
Facility:
Name:
Wales Cancer Trials Unit
Address:
City:
Cardiff
Zip:
CF11 9LJ
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Contact Person
Phone:
44-29-2019-6800
Start date:
January 2009
Lead sponsor:
Agency:
Wales Cancer Trials Unit
Agency class:
Other
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01196403
