MDACC Study Summary 2007-0933

Study Summary
No. 2007-0933:.......Bladder; Genitourinary......Seungtaek Choi......Radiation Oncology

Study Summary Title



Study Summary Number:	2007-0933

Study Title:	Prophylactic Cranial Irradiation (PCI) for Patients with Small Cell Carcinoma of the Urothelium

Physician

New Patient Referral



Name:	Seungtaek Choi	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-8617 Contact us about clinical trials

General Information



Disease Group:	Bladder Genitourinary	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	The patient will follow-up with Dr. Seungtaek Choi after each MRI or CT of the brain (at 6 and 12 months after study entry, then annually). The patients will be followed for a maximum of 5 years.

Treatment Agents:	Radiation	Home Care:	None.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	None.


Description/ Intervention:	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.

Study Objectives / Outcomes

Primary

To evaluate the effect of prophylactic cranial irradiation (PCI) on brain metastasis free survival at
1 year in patients with locally advanced/metastatic (i.e. > or = cT3b, > or = pT3b, N+, or M+) small
cell carcinoma of the urothelium after chemotherapy.

Secondary
To evaluate the effect of prophylactic cranial irradiation (PCI) on median time to develop brain
metastases in patients with locally advanced/metastatic small cell carcinoma of the urothelium after
chemotherapy.

To evaluate the effect of PCI on overall survival of patients with locally advanced/metastatic small
cell carcinoma of the urothelium after chemotherapy.

To evaluate the toxicity of PCI in patients with locally advanced/metastatic small cell carcinoma of
the urothelium after chemotherapy.

Study Status Information



Study Activation / Registration Date:	07/21/2008

IRB Review and Approval Date:	07/21/2008

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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 > 100,000. 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.

Links

Registration Number: NCT00756639
Study Information on Clinical Trials Registry (clinicaltrials.gov)