Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Urothelium
2 other identifiers
interventional
31
1 country
1
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 bladder. The safety of whole brain radiation will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2008
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 21, 2008
CompletedFirst Submitted
Initial submission to the registry
September 18, 2008
CompletedFirst Posted
Study publicly available on registry
September 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
December 17, 2025
December 1, 2025
19.5 years
September 18, 2008
December 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brain Metastasis Free Survival
Primary outcome for this trial is the rate of development of brain metastasis by 12 months following start of treatment. A "success" defined as a patient not developing brain metastasis by 12 months following start of treatment. After radiation therapy, participant has an MRI or a CT scan of the brain every 6 months for 1 year.
At 1 Year
Study Arms (1)
Radiation
EXPERIMENTALProphylactic cranial irradiation (PCI) treatments to be started within 4 months after the end of chemotherapy or surgery to a total dose of 30 Gy, given at 2 Gy per fraction, 5 days per week for 3 weeks. On the first day of each week of therapy, a brain X-ray will done to see if the radiation is being given to the best area.
Interventions
Prophylactic cranial irradiation (PCI) treatments to be started within 4 months after the end of chemotherapy or surgery to a total dose of 30 Gy, given at 2 Gy per fraction, 5 days per week for 3 weeks.
On the first day of each week of therapy, a brain X-ray will done to see if the radiation is being given to the best area.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seungtaek Choi, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2008
First Posted
September 22, 2008
Study Start
July 21, 2008
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
December 17, 2025
Record last verified: 2025-12