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

Running, not enrolling · Phase 2

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT00756639

Run by

M.D. Anderson Cancer Center

People needed

31

Starts

2008-07-21

Expected to finish

2027-12-31

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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