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Standard Surgery or Minimal-Access Surgery in Treating Patients With Bladder Cancer
Conditions
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
Study Design
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: questionnaire administration
Type: Other
Name: quality-of-life assessment
Type: Procedure
Name: robot-assisted laparoscopic surgery
Type: Procedure
Name: therapeutic conventional surgery
Type: Procedure
Name: therapeutic laparoscopic surgery
Type: Procedure
Overall Status
Recruiting
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.
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.
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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
- 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
Locations
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Guy's Hospital
Status: Recruiting
Contact: Contact Person - 44-1223-245-151
London, England, United Kingdom
University College of London Hospitals
Status: Recruiting
Contact: Contact Person - 44-20-7188-7188
London, England, United Kingdom
Wales Cancer Trials Unit
Status: Recruiting
Contact: Contact Person - 44-20-3108-2050 - j.d.kelly@ucl.ac.uk
Cardiff, Wales, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-29-2019-6800
Start Date
January 2009
Sponsors
Wales Cancer Trials Unit
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page