Brain radiation may stop cancer spread in rare bladder cancer
NCT ID NCT00756639
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether whole brain radiation can lower the chance of brain tumors in people with small cell carcinoma of the urinary tract (including the bladder). The 31 participants have already had chemotherapy and responded well. They receive radiation to the brain for 3 weeks, and are monitored for a year to see if brain metastases develop.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- whole brain radiation (prophylactic cranial irradiation)
- What this could lead to
- If it works, this could point toward a way to prevent brain metastases in people with this rare bladder cancer.
- What could go wrong
- This is a small, early-phase trial with only 31 participants, so results may not apply to everyone. The radiation itself can have side effects like memory problems or fatigue.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
31 people
The number who actually took part.
- Started
-
Jul 2008
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 allowed. 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bladder cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Dutch bladder cancer cohort aims to map survival and recurrence
- Can two drugs plus chemoradiation let bladder cancer patients keep their bladder?
- Lab-Grown tumor organoids could pick the right bladder chemo
- Can tumor genes decide who keeps their bladder?
- Lab-Grown tumor models could match patients to the right cancer drug
- Can heated saline during bladder surgery stop tumors from coming back?