Bladder Cancer Clinical Trial
Have you or your loved ones been diagnosed with bladder cancer?
You may be eligible to participate in a bladder cancer clinical trial.
Have you or your loved ones been diagnosed with bladder cancer? You may be eligible to participate in a bladder cancer clinical trial.
Recruiting 1665 Aurora Court, Aurora, CO, USA 80045
Recruiting 1650 Orleans Street, Baltimore, MD, USA 21287
Recruiting Halifax, Nova Scotia, CAN B3H 1V8
Recruiting 6620 South Main Street, Houston, TX, USA 77030
Details for the study
Treatments and/or Procedures
DISEASE CHARACTERISTICS: - Histologically confirmed urothelial carcinoma of the bladder - Stage T2, T3, or T4a disease - No clinical stage consistent with a low-risk of node metastasis (CIS only, T1) - No T4b disease (fixed lesion) - Disease that requires primary radical cystectomy and lymph node dissection for definitive treatment - No laparoscopic surgery - Predominant urothelial carcinoma with any of the following elements allowed: - Adenocarcinoma - Squamous cell carcinoma - Micropapillary or minor components of other rare phenotype - No pure squamous cell carcinoma or adenocarcinoma - No visceral or nodal metastatic disease proximal to the common iliac bifurcation by 2-view chest x-ray and abdominal-pelvic imaging by computerized tomography or MRI of the abdomen and pelvis - No intra-operative pelvic lymph node involvement (confirmed by frozen section) at or above the bifurcation of the common iliac vessels in any of the extended template PATIENT CHARACTERISTICS: - Zubrod performance status 0-2 - ALT and AST ≤ upper limit of normal (ULN)* - Alkaline phosphatase ≤ ULN* - Not pregnant or nursing - Fertile patients must use an effective contraception - No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or stage I or II cancer from which the patient is in complete remission for the past 5 years - Medically suitable to undergo cystectomy, in the physician's opinion NOTE: *Levels may be ≥ ULN provided metastatic disease is excluded using dedicated liver imaging, bone scan, or biopsy. PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior partial cystectomy for invasive bladder cancer - No prior pelvic surgery that would obviate a complete extended lymphadenectomy (e.g., aorto-femoral/iliac bypass) - Prior neoadjuvant chemotherapy for this cancer allowed provided it has been completed and patient has recovered - No prior pelvic irradiation