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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether whole brain radiation, known as Prophylactic Cranial Irradiation (PCI), can reduce the risk of brain tumors in individuals with small cell carcinoma of the urinary tract, such as the bladder. The study also evaluates the safety of this radiation treatment for patients. Individuals with small cell carcinoma of the bladder who have responded well to chemotherapy and do not have brain metastases may be suitable candidates for this study. The treatment involves brain radiation over three weeks, starting within four months after chemotherapy or surgery. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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 there any evidence suggesting that Prophylactic Cranial Irradiation is likely to be safe for humans?

Research has shown that prophylactic cranial irradiation (PCI), a type of brain radiation, is generally safe for patients. However, specific safety information about using PCI for bladder cancer patients remains limited. In studies involving patients with small cell urothelial cancer, PCI reduced the risk of cancer spreading to the brain, suggesting its potential benefit.

Radiation therapy like PCI can cause side effects, such as tiredness, hair loss, or skin irritation at the radiation site. Despite these possible side effects, patients with similar types of cancer have generally tolerated PCI well. This trial is in Phase 2, indicating that earlier studies demonstrated some safety, but more research is needed to fully understand its safety for bladder cancer patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for bladder cancer that primarily target the bladder itself, Prophylactic Cranial Irradiation (PCI) is unique because it focuses on preventing potential cancer spread to the brain. While common treatments like chemotherapy and surgery aim at removing or shrinking bladder tumors, PCI offers a proactive approach by delivering targeted radiation to the brain, reducing the risk of metastasis. Researchers are excited about PCI because it represents a novel strategy to improve long-term outcomes and potentially enhance overall survival rates for patients by addressing an often-overlooked area of cancer progression.

What evidence suggests that Prophylactic Cranial Irradiation is effective for preventing brain tumors in bladder cancer patients?

Research has shown that Prophylactic Cranial Irradiation (PCI) can greatly reduce the risk of brain tumors in patients with small cell cancer of the urinary tract, including the bladder. For those with more advanced stages of this cancer, PCI has decreased the risk of brain tumors spreading by up to 50%. One study found that PCI reduced the occurrence of noticeable brain tumors by 26% after one year. In this trial, participants will receive PCI treatments to assess its effectiveness in preventing brain tumors in individuals with this type of cancer. ^{4 5 6 7 8}

Who Is on the Research Team?

Seungtaek Choi, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30521161/

Small cell bladder cancer: should we consider prophylactic ... Six patients (14%) received PCI. Median overall survival was 10 months (IQR 4 - 41). Patients with extensive disease had worse overall survival than those with ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0923753419395389

Symptomatic brain metastases from small-cell carcinoma of ... PCI decreased the cumulative incidence of symptomatic brain metastases at 1 year by 26% with only mild adverse effects [14, 25]. Following these arguments and ...

3. researchgate.net researchgate.net/publication/331601153_Prophylactic_cranial_irradiation_PCI_significantly_decreases_risk_of_brain_metastases_in_patients_with_bulky_higher_stage_small-cell_urothelial_cancer

Prophylactic cranial irradiation (PCI) significantly decreases risk ... Conclusions: In this study, PCI decreased the risk of developing brain metastases in patients with bulky, higher-stage small cell urothelial cancer from 50% ( ...

4. auajournals.org auajournals.org/doi/pdf/10.1016/j.juro.2016.02.2172

MP06-11 SMALL CELL BLADDER CANCER and 6 (14%) had prophylactic cranial irradiation. Median follow up was. 15 months (IQR 4-47). There was a 10 month (IQR 4-41) median overall survival and a ...

5. oncologynewscentral.com oncologynewscentral.com/sclc/as-immunotherapy-transforms-sclc-care-questions-linger-about-prophylactic-cranial-irradiation

As Immunotherapy Transforms SCLC Care, Questions ... However, the trials that led to these approvals lacked data informing clinicians on the role of prophylactic cranial irradiation (PCI).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6541124/

Small cell bladder cancer: should we consider prophylactic ... Six patients (14%) received PCI. Median overall survival was 10 months (IQR 4 – 41). Patients with extensive disease had worse overall survival than those with ...

7. urotoday.com urotoday.com/index.php?option=com_content&view=article&id=108994:small-cell-bladder-cancer-should-we-consider-prophylactic-cranial-irradiation&catid=1160:bladder-cancer&utm_source=newsletter_6105&utm_medium=email&utm_campaign=uroalerts-oncology-weekly&acm=_6105

Small cell bladder cancer: should we consider prophylactic ... Six patients (14%) received PCI. Median overall survival was 10 months (IQR 4 - 41). Patients with extensive disease had worse overall survival ...

8. withpower.com withpower.com/trial/phase-3-small-cell-lung-carcinoma-6-2008-4a50e

Brain Radiation for Bladder Cancer · Info for Participants 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 ...