Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
Completed · Phase 1
Conditions studied: Bladder Cancer
In brief
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.
Key facts
- Study ID
- NCT01104350
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 19
- Starts
- 2010-04-01
- Expected to finish
- 2026-03-03
- Last updated by the study team
- 2026-03-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- Memorial Sloan Kettering at Mercy Medical Center — Rockville Centre, New York, United States
Full record on ClinicalTrials.gov
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