← Back to Search

Radiation

Brain Radiation for Bladder Cancer

Phase 2

Waitlist Available

Led By Seungtaek Choi, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be > or = 18 years of age

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year

Awards & highlights

Study Summary

This trial will test whether whole brain radiation can help prevent brain tumors in patients with small cell carcinoma of the urinary tract. The safety of whole brain radiation will also be studied.

Who is the study for?

This trial is for adults over 18 with small cell carcinoma of the urinary tract, including bladder cancer, who've responded to chemotherapy or surgery. They must have no brain tumors on recent scans and be in good health with adequate bone marrow function. Pregnant women or those with a history of stroke/TIA within six months are excluded.Check my eligibility

What is being tested?

The study tests if whole brain radiation (Prophylactic Cranial Irradiation) can prevent brain tumors in patients treated for small cell carcinoma of the urothelium. It also assesses the safety of this preventive brain X-ray treatment.See study design

What are the potential side effects?

While not specified here, common side effects from whole brain radiation may include fatigue, hair loss at irradiated sites, headaches, nausea, and memory problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have advanced or metastatic small cell bladder cancer treated with chemotherapy.

Select...

I finished my chemotherapy or surgery less than 6 months ago and have recovered from major side effects.

Select...

My cancer has not gotten worse recently.

Select...

I will have brain radiation to prevent cancer spread after recovering from chemotherapy or surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Brain Metastasis Free Survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: RadiationExperimental Treatment2 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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,750 Total Patients Enrolled

Seungtaek Choi, MDPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

1,148 Total Patients Enrolled

Media Library

Prophylactic Cranial Irradiation (PCI) (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT00756639 — Phase 2

Bladder Cancer Research Study Groups: Radiation

Bladder Cancer Clinical Trial 2023: Prophylactic Cranial Irradiation (PCI) Highlights & Side Effects. Trial Name: NCT00756639 — Phase 2

Prophylactic Cranial Irradiation (PCI) (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00756639 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for individuals to become part of this research?

"The clinical trial in question is not presently recruiting participants, as evidenced on the website. It was initially posted on July 21st 2008 and last updated August 18th 2022. However, there are a plethora of opportunities for participation with over two thousand nine hundred seventy-six other medical trials currently searching for candidates."

Answered by AI

Is Brain X-ray a risk-free imaging technique?

"Brain X-ray's safety has been assessed as a 2 on the scale of 1 to 3. This is because, while there is some evidence indicating its security, efficacy data is still missing due to this being Phase 2 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2008. "Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Urothelium". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00756639.

All > Bladder Cancer