R0926 A Phase II Protocol for Patients with Stage T1 Bladder Cancer to Evaluate Selective Bladder Preserving Treatment by Radiation Therapy Concurrent with Radiosensitizing Chemotherapy Following a Thorough Transurethral Surgical Re-Staging
The purpose of this study is to find out the effects of transurethral surgery followed by radiation therapy plus cisplatin chemotherapy. Although the combination of radiation therapy and cisplatin chemotherapy used in this study is not an experimental treatment because it is used for patients with more advanced bladder cancer (the type that has invaded the bladder muscle), the use of this approach in this study is new for patients like you with a stage T1 bladder cancer.
Age 18 or older. Pathologically proven diagnosis of bladder cancer without any spread to other parts of the body. No other existing cancer. Should have adequately functioning bladder. Lab tests must fall into required study range. Individuals who have AIDS, Liver problems, or who have had a heart attack within the last 6 months are not eligible. Pregnant women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception are not eligible.
Step_1: carried out to find if you can be in the study and includes history and physical exam, including an assessment of your ability to carry out activities of daily living, Blood tests ,Pregnancy test for women who are able to have children and then surgical removal of the tumor. Step_2: If the exams, tests and procedures show that you can be in the study, and you choose to take part, then: Lab tests and imaging studies are done. Step 3: Radiation therapy once a day, 5 days a week for about 7 weeks. During the first 3 days of week 1, week 3 and week 5, you will also be given chemotherapy (cisplatin) by vein. Follow up lab tests, imaging and assessments are done. After you have finished radiation and chemotherapy if your tumor comes back your doctor may recommend other treatment options (for example, cystectomy â?? the surgical removal of your bladder). The type of treatment recommended will vary based on the type of tumor you have. Population: Adult
05/22/2013 04:02 AM