Bladder Cancer
Conditions
Keywords
Bladder, Radiotherapy, Gemcitabine, Chemotherapy, 10-031
Brief 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.
Interventions
OTHERexternal radiation therapy with gemcitabine
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)
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the dose limiting toxicity and establish the maximal tolerated dose | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| To determine the complete response rate of the primary tumor | 4-6 weeks following consolidation therapy |
| To determine the long term toxicity | 2 years |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMarisa Kollmeier, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed