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BRIEF TITLE: Prophylactic Cranial Irradiation (PCI) for Patients With Small Cell Carcinoma of the Urothelium

Prophylactic Cranial Irradiation (PCI) for Patients With Small Cell Carcinoma of the Urothelium

  • Org Study ID: 2007-0933
  • Secondary ID: NCI-2012-01675
  • NCT ID: NCT00756639
  • NCT Alias:
  • Sponsor: M.D. Anderson Cancer Center - Other
  • Source: M.D. Anderson Cancer Center

Brief 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.

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

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

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.


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.

Overal Status Start Date Phase Study Type
Recruiting June 2008 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Brain Metastasis Free Survival

Primary Outcome 1 - Time Frame: At 1 Year


  • Bladder Cancer


Inclusion Criteria:

1. 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.

2. 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.

3. 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

4. Patients must be > or = 18 years of age.

5. 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.

6. Patients must not have any evidence of progressive disease at the time of study entry.

7. Patients must have an MRI or CT of the head showing no CNS metastases within 6 weeks
of study entry.

8. 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.

9. 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.

Exclusion Criteria:

1. Patients with CNS metastasis at presentation will not be eligible.

2. History of TIA or stroke within 6 months of study entry.

3. Prior cranial irradiation.

4. Pregnant women will not be eligible; women of childbearing potential must have a
negative pregnancy test before starting therapy.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Seungtaek Choi, MD

Role: Principal Investigator

Affiliation: M.D. Anderson Cancer Center

Overall Contact

Name: Seungtaek Choi, MD

Phone: 713-563-8617


Link: University of Texas MD Anderson Cancer Center Website


Facility Status Contact
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting Toni Williams