Brain Radiation for Bladder Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: CNS metastasis, TIA, stroke, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

31 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team to get a clear answer.

Is brain radiation generally safe for humans?

While specific safety data for brain radiation in bladder cancer is limited, radiation therapy in general can have side effects. For example, radiation to the bladder can cause urinary issues like frequency and bleeding, and similar side effects might occur with brain radiation. However, modern techniques aim to reduce these risks. ^{1 2 3 4 5}

How is the treatment Prophylactic Cranial Irradiation (PCI) unique for bladder cancer?

Prophylactic Cranial Irradiation (PCI) is unique for bladder cancer because it is typically used to prevent brain metastases in cancers like small-cell lung cancer, and its use in bladder cancer is not standard. This treatment involves targeting the brain with radiation to prevent cancer spread, which is not a common approach for bladder cancer patients. ^{6 7 8 9 10}

Research Team

Seungtaek Choi, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

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

My recent brain scan shows no signs of cancer spread.

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

Exclusion Criteria

I have had a stroke or a mini-stroke in the last 6 months.

I am not pregnant and have a negative pregnancy test.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

MRI or CT scan of the brain

Simulation Visit

Participants undergo a simulation visit to plan for radiation therapy, including fitting for a thermoplastic mask and a CT scan for treatment planning

1 visit

Radiation Therapy

Participants receive whole brain radiation therapy, 5 days per week for 3 weeks, with a total of 15 therapy visits

3 weeks

15 visits (in-person)

Follow-up

Participants are monitored for brain metastasis and undergo MRI or CT scans every 6 months for 1 year, then annually for 5 years. Mental status exams are conducted every 3-6 months for 2 years, then annually for 5 years

5 years

Regular MRI/CT scans and mental status exams

Treatment Details

Interventions

• Prophylactic Cranial Irradiation (PCI)

Trial Overview 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.

Participant Groups

Group I: Radiation Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

References

1. France pubmed.ncbi.nlm.nih.gov

[Normal tissue tolerance to external beam radiation therapy: bladder]. [2016]

2. Greece pubmed.ncbi.nlm.nih.gov

Predicting Survival After Whole-brain Irradiation for Cerebral Metastases in Patients with Cancer of the Bladder. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Radiation-induced cystitis following intracavitary irradiation for superficial bladder cancer. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Radiotherapy for carcinoma of the bladder: a review. [2019]

5. France pubmed.ncbi.nlm.nih.gov

[Late effects of radiations on the bladder]. [2019]

6. Brazil pubmed.ncbi.nlm.nih.gov

Small cell bladder cancer: should we consider prophylactic cranial irradiation? [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Prophylactic cranial irradiation in advanced breast cancer: a case for caution. [2009]

8. England pubmed.ncbi.nlm.nih.gov

Symptomatic brain metastases from small-cell carcinoma of the urinary bladder: The Netherlands Cancer Institute experience and literature review. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Hypofractionated whole-brain radiotherapy for multiple brain metastases from transitional cell carcinoma of the bladder. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Brain metastases from bladder carcinoma: presentation, treatment and survival. [2022]