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

Prior treatment

• Prior cranial irradiation.
• Pregnant women will not be eligible; women of childbearing potential must have a negative pregnancy test before starting therapy.

Other illness

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

Other

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

• 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.
• 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.