adjuvant radiation for high risk bladder cancer

Conditions: Bladder Cancer; Squamous Cell Carcinoma of the Bladder; Stage III Bladder Cancer; Stage IV Bladder Cancer; Transitional Cell Carcinoma of the Bladder

Summary: this phase ii trial studies how well modern, conformal radiation therapy after surgery works in treating patients with high-risk bladder cancer. specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

primary objective: i. determine the feasibility of adjuvant radiation in the management of high-risk disease. secondary objectives: i. prospectively evaluate patterns of failure in high-risk bladder cancer patients after cystectomy and aggressive adjuvant therapy. ii. define surgical and histopathologic parameters predictive of local and distant outcomes (e.g. grade, lymphovascular space invasion \[lvsi\], extent of resection/lymph node dissection \[lnd\]). iii. assess quality of life (qol) outcomes after this treatment using a standardized questionnaires (functional assessment of cancer therapy-general \[fact-g\], fact-bladder cancer \[bl\], expanded prostate cancer index composite \[epic\] bowel and urinary). outline: within 24 weeks of surgical resection, patients undergo 3d conformal radiation therapy once daily 5 days per week for 28 fractions. treatment continues in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed up at 4 weeks, every 3 months for 2 years, every 6 months for 3-5 years, and then annually thereafter.

Eligibility criteria:
inclusion criteria: * pathologic diagnosis of urothelial or squamous cell carcinoma of the bladder * patients must have undergone cystectomy (total cystectomy, radical cystectomy +/- pelvic lymph node dissection) with no evidence of macroscopic residual disease * eastern cooperative oncology group (ecog)/zubrod performance status of 0-2 * patients treated with simple cystectomy with macroscopically negative margins are eligible for this study * clinical t-stage (prior to systemic therapy, if applicable) ≥ t3a and/or positive lymph nodes by transurethral resection of bladder tumor (turbt)/magnetic resonance imaging (mri)/computed tomography (ct)/positron emission tomography (pet)-ct or pathologic t-stage ≥ t3a and/or positive lymph nodes exclusion criteria: * patients with metastatic disease outside of the pelvis * prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years * prior radiation therapy to the pelvis * patients with active inflammatory bowel disease * severe acute co-morbidity, defined as follows: * unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months * transmural myocardial infarction within the last 6 months * acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * acquired immune deficiency syndrome (aids) based upon current centers for disease control and prevention (cdc) definition; note, however, that human immunodeficiency virus (hiv) testing is not required for entry into this protocol; the need to exclude patients with aids from this protocol is necessary because the treatment involved in this protocol may be significantly immunosuppressive; protocol-specific requirements may also exclude immunocompromised patients