Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
Bladder, Radiotherapy, Gemcitabine, Chemotherapy, 10-031
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: external radiation therapy with gemcitabine
Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States
Status: Recruiting
Contact: Marisa Kollmeier, MD - 212-639-3952
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States
Status: Recruiting
Contact: Marisa Kollmeier, MD - 212-639-3952
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Marisa Kollmeier, MD - 212-639-3952
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Status: Recruiting
Contact: Marisa Kollmeier, MD - 212-639-3952
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, United States
Status: Recruiting
Contact: Marisa Kollmeier, MD - 212-639-3952
Memorial Sloan Kettering West Harrison
West Harrison, New York, United States
Status: Recruiting
Contact: Marisa Kollmeier, MD - 212-639-3952
Start Date
April 2010
Completion Date
April 2017
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page