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

Protocol
10-031
Full Title
Phase I Dose-Escalation Study of Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
Phase
I
Purpose

The purpose of this study is to evaluate the safety of different doses of image-guided radiation therapy combined with chemotherapy in patients with bladder cancer that has invaded the bladder muscle but has not spread elsewhere in the body.

Most patients with this stage of bladder cancer receive chemotherapy followed by surgical bladder removal. Removing just the cancer surgically and then using radiation therapy and chemotherapy together is another form of treatment — though 30 percent of these patients experience a recurrence of the cancer, and some of them need to have their bladders removed.

Doctors would like to know if a higher dose of radiation to the bladder can reduce the risk of recurrence and the need for surgery. Patients will first receive the drug gemcitabine plus radiation therapy. If the cancer responds well to the chemotherapy and radiation, then a second course of treatment with gemcitabine and a higher dose of radiation will be used.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of urothelial bladder cancer that has invaded the bladder muscle but has not metastasized.
  • Patients may not have had prior chemotherapy for bladder cancer nor pelvic radiation therapy.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Marisa Kollmeier at 212-639-3952.

Disease(s)
Bladder Cancer
Related Diseases