Bladder CancerPhase 2NCT00756639
Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Urothelium
A Phase 2 study testing Prophylactic Cranial Irradiation (PCI) and Brain X-ray in people with Bladder Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if whole brain radiation can lower the chances of developing brain tumors in patients with small cell carcinoma of the urinary tract, including the bladder. The safety of whole brain radiation will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Prophylactic Cranial Irradiation (PCI) and Brain X-ray
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2008to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically proven small cell carcinoma of the bladder, or elsewhere along the urothelium, which is locally advanced or metastatic (i.e. > or = cT3b, > or = pT3b, N+, or M+) at the time of presentation or cystectomy who have been treated with chemotherapy.
- Patients must have had a response to chemotherapy, which the investigator feels is likely to resulting systemic control of the cancer. In most instances, this would reflect a major response (i.e. > or = 90% reduction of tumor), though a lower percentage may be acceptable if the investigator feels the residual reflects another component, such as transitional cell carcinoma (TCC). Dr Arlene Siefker-Radtke will serve as the final arbiter when questions regarding response arise.
- Since small cell tumors of the bladder are often associated with other variant histology including TCC and adenocarcinoma, the presence of variant histology will be allowed.
- Patients must be > or = 18 years of age.
- Patients may be on other trials (either here at M.D. Anderson Cancer Center or at an outside institution) as long as the other eligibility criteria are met.
- Patients must not have any evidence of progressive disease at the time of study entry.
Show all 9Show fewer
- Patients must have an MRI or CT of the head showing no CNS metastases within 6 weeks of study entry.
- Patients must have adequate physiologic reserves as evidenced by: a) Zubrod Performance Status (PS) of < or = 2; b) Adequate bone marrow reserves as evidenced by ANC > 1000, and platelet count > 75,000. Supranormal values judged to be of benign or inconsequential etiology will be acceptable.
- Patients must be enrolled within 6 months of completing chemotherapy or after surgery of the primary site. Any acute/subacute > or = grade 3 toxicities from the chemotherapy must be resolved to < or = grade 2 at the time of study entry. It is suggested that patients undergo prophylactic cranial irradiation as a soon as they have recovered from chemotherapy or surgery, at a minimum of 2 weeks, and up to 6 months following chemotherapy or surgery.
Who cannot join
- Patients with CNS metastasis at presentation will not be eligible.
- History of TIA or stroke within 6 months of study entry.
- Prior cranial irradiation.
- Pregnant women will not be eligible; women of childbearing potential must have a negative pregnancy test before starting therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Prophylactic Cranial Irradiation (PCI) for Patients With Small Cell Carcinoma of the Urothelium
The goal of this clinical research study is to learn if whole brain radiation can lower the chances of developing brain tumors in patients with small cell carcinoma of the urinary tract, including the bladder. The safety of whole brain radiation will also be studied.
Read the detailed description
Pregnancy Test:
Women who are able to have children must have a negative urine pregnancy test to be eligible for this study.
MRI/CT Scans:
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.
Simulation Visit:
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.
Radiation Therapy:
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.
Follow-Up:
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.
- Conditions
- Bladder Cancer
- Being tested
- Prophylactic Cranial Irradiation (PCI), Brain X-ray
- Keywords
- small cell carcinoma of the bladder, urothelial carcinoma, genitourinary bladder, urothelium, bladder, bladder cancer, prophylactic cranial irradiation, PCI, brain metastasis, genitourinary, radiation, TCC, adenocarcinoma
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Brain Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic Cranial Irradiation (PCI)Radiation
Also called Whole Brain 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.
Brain X-rayOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Radiation | Experimental | 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. Receives: Radiation: Prophylactic Cranial Irradiation (PCI); Other: Brain X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Metastasis Free Survival
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.
Measured: At 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study start21 Jul 2008
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seungtaek Choi, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756639
- Sponsor's protocol ID
- 2007-0933
- Other IDs
- NCI-2012-01675
- Status last verified
- Jun 2026
- First submitted
- 18 Sep 2008
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Cranial Irradiation (PCI) for Patients With Small Cell Carcinoma of the Urothelium
- ClinicalTrials.gov ID
- NCT00756639
- Acronym / sponsor ID
- 2007-0933
- Conditions
- Bladder Cancer
- Keywords
- small cell carcinoma of the bladder, urothelial carcinoma, genitourinary bladder, urothelium, bladder, bladder cancer, prophylactic cranial irradiation, PCI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 21 Jul 2008 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if whole brain radiation can lower the chances of developing brain tumors in patients with small cell carcinoma of the urinary tract, including the bladder. The safety of whole brain radiation will also be studied.
Detailed description
Pregnancy Test:
Women who are able to have children must have a negative urine pregnancy test to be eligible for this study.
MRI/CT Scans:
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.
Simulation Visit:
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.
Radiation Therapy:
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.
Follow-Up:
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation | Experimental | Radiation: Prophylactic Cranial Irradiation (PCI), Other: Brain X-rayProphylactic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with histologically proven small cell carcinoma of the bladder, or elsewhere along the urothelium, which is locally advanced or metastatic (i.e. > or = cT3b, > or = pT3b, N+, or M+) at the time of presentation or cystectomy who have been treated with chemotherapy.
- Patients must have had a response to chemotherapy, which the investigator feels is likely to resulting systemic control of the cancer. In most instances, this would reflect a major response (i.e. > or = 90% reduction of tumor), though a lower percentage may be acceptable if the investigator feels the residual reflects another component, such as transitional cell carcinoma (TCC). Dr Arlene Siefker-Radtke will serve as the final arbiter when questions regarding response arise.
- Since small cell tumors of the bladder are often associated with other variant histology including TCC and adenocarcinoma, the presence of variant histology will be allowed.
- Patients must be > or = 18 years of age.
- Patients may be on other trials (either here at M.D. Anderson Cancer Center or at an outside institution) as long as the other eligibility criteria are met.
Key exclusion criteria (4 listed)
- Patients with CNS metastasis at presentation will not be eligible.
- History of TIA or stroke within 6 months of study entry.
- Prior cranial irradiation.
- Pregnant women will not be eligible; women of childbearing potential must have a negative pregnancy test before starting therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylactic Cranial Irradiation (PCI)Also: Whole Brain Radiation, Prophylactic cranial irradiation, PCIProphylactic 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. | Radiation | Radiation |
| Brain X-rayAlso: X-rayOn 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 | Radiation |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seungtaek Choi, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prophylactic Cranial Irradiation (PCI) and Brain X-ray in people with Bladder Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Metastasis Free Survival (time frame: At 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.