Status:
ACTIVE_NOT_RECRUITING
Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Urothelium
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Pregnancy Test: Women who are able to have children must have a negative urine pregnancy test to be eligible for this study. MRI/CT Scans: Within six (6) weeks before having whole brain radiation, ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 21 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2027
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00756639
Start Date
July 21 2008
End Date
December 31 2027
Last Update
December 17 2025
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030