Phase I Dose-Escalation Study of Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy

Inclusion Criteria:

- MSKCC-reviewed pathologically proven diagnosis of primary bladder urothelial
carcinoma without evidence of regional (nodal) or distant spread (cT1-T4a, Nx or N0).

- Karnofsky Performance Scale (KPS) ≥ 70%

- Age ≥18 years old

- Adequately functioning bladder, defined as continent and without the need for an
indwelling catheter

- Absolute neutrophil count (ANC) ≥ 1500/mL; platelets ≥ 100,000/mm3 serum bilirubin <
1.5 x the upper limit of normal (ULN); aspartate aminotransferase (AST) and/alanine
aminotransferase (ALT) ≤ 1.5 × ULN

- Adequate renal function: calculated creatinine clearance > 30 mL/min/1.73 m2 using
the following formula modified Cockcroft and Gault Formula for estimated Creatinine
Clearance

- Patients must be considered able to tolerate systemic chemotherapy and pelvic
radiation therapy.

- Patients must have the ability to understand and the willingness to sign a written
informed consent document

Exclusion Criteria:

- Evidence of distant disease or histologically-proven nodal metastases. Patients with
radiologic evidence of lymphadenopathy must have biopsy proof of N0 status.

- Previous pelvic radiation therapy

- Prior systemic chemotherapy non-cisplatin based neoadjuvant for urothelial carcinoma
(prior intravesical chemotherapy or immunotherapy is permissible)

- Prior cisplatin based neoadjuvant systemic chemotherapy for more than >4 cycles

- Active inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis)

- Women who are pregnant or lactating