Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy



Status:Active, not recruiting
Conditions:Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:April 2010
End Date:April 2020

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Phase I Dose-Escalation Study of Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy

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.


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
We found this trial at
5
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Marisa Kollmeier, MD
Phone: 212-639-3952
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Basking Ridge, New Jersey 07920
Phone: 212-639-3952
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Basking Ridge, NJ
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Commack, New York 11725
Phone: 212-639-3952
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Commack, NY
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500 Westchester Avenue
Harrison, New York 10604
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Harrison, NY
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1000 N Village Ave
Rockville Centre, New York 11570
(516) 256-3600
Phone: 212-639-3952
Memorial Sloan-Kettering at Mercy Medical Center Memorial Sloan Kettering Cancer Center Rockville Centre provides state-of-the-art...
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Rockville Centre, NY
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