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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

Must not have

Pregnant women will not be eligible; women of childbearing potential must have a negative pregnancy test before starting therapy

Patients with CNS metastasis at presentation will not be eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I am 18 years old or older.

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

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

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My cancer has not gotten worse recently.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant and have a negative pregnancy test.

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I do not have cancer that has spread to my brain.

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I have had radiation therapy to my brain before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brain Metastasis Free Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 8Eligibility criteria met