Bladder Cancer | Standard Surgery or Minimal-Access Surgery in Treating Patients With Bladder Cancer
Bladder Cancer research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:robot-assisted laparoscopic surgery
Procedure:therapeutic conventional surgery
Procedure:therapeutic laparoscopic surgery
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: January 2009
Phase: Phase 2
Primary Outcome: Percentage of patients who consent to be randomized
Secondary Outcome: Potential barriers to randomization via semistructured qualitative interviews with patients who consent to registration and do not accept randomization
Study sponsors, principal investigator, and references
Principal Investigator: John Kelly, MD
Lead Sponsor: Wales Cancer Trials Unit