Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Urothelium (NCT00756639)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• University of Texas MD Anderson Cancer Center — Houston, Texas

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.