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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
All patients will undergo daily image-guided radiation therapy with concurrent twice weekly gemcitabine chemotherapy. Radiation therapy will begin 2-4 weeks after restaging cystoscopy/fiducial marker placement. * Dose level #1: 23.4 Gy/1.8 Gy × 13 fractions (total dose 68.4 Gy) * Dose level #2: 27.0 Gy/1.8 Gy × 15 fractions (total dose 72.0 Gy) * Dose level #3: 30.6 Gy/1.8 Gy × 17 fractions (total dose 75.6 Gy)
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
To determine the dose limiting toxicity and establish the maximal tolerated dose
Time frame: 2 years
To determine the complete response rate of the primary tumor
Time frame: 4-6 weeks following consolidation therapy
To determine the long term toxicity
Time frame: 2 years
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Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States