Bladder Cancer Clinical Trial
Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
Summary
The purpose of this study is to test the safety of different amounts (doses) of external radiation therapy (high-energy x-rays that shrink or destroy cancer) combined with chemotherapy.
Eligibility Criteria
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
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There are 4 Locations for this study
Basking Ridge New Jersey, 07920, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10065, United States
Rockville Centre New York, , United States
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