Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Urothelium
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00756639|
Recruitment Status : Active, not recruiting
First Posted : September 22, 2008
Last Update Posted : April 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Radiation: Prophylactic Cranial Irradiation (PCI) Other: Brain X-ray||Phase 2|
Women who are able to have children must have a negative urine pregnancy test to be eligible for this study.
Within six (6) weeks before having whole brain radiation, you will have a magnetic resonance imaging (MRI) or a computed tomography (CT) scan of your brain to check if brain tumors have developed.
Before the radiation therapy begins, you will have a "simulation visit" to plan for the radiation therapy. During this session, you will be fitted to a plastic mask to hold your head still during radiation. The mask is made of a material called "thermoplastic" that becomes soft when it is placed in warm water. While this plastic is soft, it will be pulled over your face to make a mold. When the plastic cools down, it will harden again and the mask will be completed. After the mask is made, a CT scan of your head will be done for treatment planning.
You will begin radiation within 1 week after the simulation visit. You will have radiation visits Monday through Friday for 3 weeks (15 total therapy visits). Each therapy session will last about 15 minutes. It will take the study staff about 10 minutes to position you on the table and put the mask on. The radiation will be given over 2-3 minutes.
On the first day of each week of therapy, you will have a brain X-ray to see if the radiation is being given to the best area.
After the radiation therapy, you will have an MRI or a CT scan of the brain every 6 months for 1 year and then every year for 5 years to check the status of the disease. More frequent scans will be performed if your doctor thinks they are needed. You will also complete a written mental status exam with your doctor every 3-6 months for 2 years and then every year for 5 years. The exam will have a series of tests to check your memory and ability to follow instructions. The test will take about 15 minutes to complete.
Length of Study:
You may remain on study for as long as you are benefitting. You will be taken off study if your disease gets worse or if intolerable side effects occur.
This is an investigational study. The use of radiation to check for brain tumors before they have formed is investigational.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prophylactic Cranial Irradiation (PCI) for Patients With Small Cell Carcinoma of the Urothelium|
|Actual Study Start Date :||July 21, 2008|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2020|
Prophylactic cranial irradiation (PCI) treatments to be started within 4 months after the end of chemotherapy or surgery to a total dose of 30 Gy, given at 2 Gy per fraction, 5 days per week for 3 weeks. On the first day of each week of therapy, a brain X-ray will done to see if the radiation is being given to the best area.
Radiation: Prophylactic Cranial Irradiation (PCI)
Prophylactic cranial irradiation (PCI) treatments to be started within 4 months after the end of chemotherapy or surgery to a total dose of 30 Gy, given at 2 Gy per fraction, 5 days per week for 3 weeks.
Other Names:Other: Brain X-ray
On the first day of each week of therapy, a brain X-ray will done to see if the radiation is being given to the best area.
Other Name: X-ray
- Brain Metastasis Free Survival [ Time Frame: At 1 Year ]Primary outcome for this trial is the rate of development of brain metastasis by 12 months following start of treatment. A "success" defined as a patient not developing brain metastasis by 12 months following start of treatment. After radiation therapy, participant has an MRI or a CT scan of the brain every 6 months for 1 year.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756639
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Seungtaek Choi, MD||M.D. Anderson Cancer Center|