Whole Brain Radiation Therapy for Blood Cancers

Overseen By Dustin M Silk

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: None

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how whole brain radiation therapy affects memory and thinking in people with blood cancers, such as certain types of lymphoma, leukemia, or myeloma. Researchers aim to understand the impact of this treatment on brain functions like memory and reasoning. Participants will undergo memory tests, complete questionnaires, and receive brain scans (MRI) at various times during and after the treatment. This trial may suit those receiving brain radiation for blood cancer who can complete tests in English. As a Phase 2 trial, the study measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to important research.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. It seems that you can continue taking medications for claustrophobia or cognitive impairment if needed.

What prior data suggests that whole brain radiation therapy is safe for patients with blood cancers?

Research shows that whole brain radiation therapy (WBRT) can cause some side effects. Common short-term effects include temporary hair loss, mild skin irritation, and fatigue. Ear problems may also occur, though they are less common.

Studies have found that WBRT rarely causes serious side effects like seizures or extreme fatigue. Concerns about memory or thinking problems after treatment exist. However, research has shown that while these issues can occur, they may improve over time for some patients.

Overall, WBRT is generally well-tolerated, but monitoring its effects on the brain and body is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial examining whole brain radiation therapy (WBRT) for hematologic malignancies because it explores the neurocognitive outcomes associated with this treatment. Unlike standard chemotherapy or targeted therapies, which primarily focus on eradicating cancer cells, WBRT is unique in its ability to address cancer that may have spread to the brain. The trial's emphasis on assessing neurocognitive function over time is crucial, as it aims to understand the potential cognitive side effects and long-term impacts of WBRT, helping to improve patient quality of life. By gathering detailed data through assessments, questionnaires, and MRIs, researchers hope to refine WBRT protocols and enhance supportive care strategies.

What evidence suggests that whole brain radiation therapy might be an effective treatment for blood cancer?

Research has shown that whole brain radiation therapy (WBRT) effectively treats cancer that has spread to the brain, known as brain metastases. In studies, more than half of the patients who survived three months after treatment reported a significant decrease in pain. WBRT also helps control the spread of cancer within the brain. This trial focuses on the effects on thinking and memory through neurocognitive assessments and questionnaires. It is important to note that WBRT is a well-established treatment for cancer in the brain. ^{6 7 8 9 10}

Who Is on the Research Team?

Bouthaina S Dabaja

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Treatment with radiation therapy to the brain for a hematologic malignancy (ex. primary central nervous system lymphoma [PCNSL], secondary central nervous system lymphoma [SCNSL], leukemia, myeloma)

Proficient and capable of completing tests in English

Patients with claustrophobia are eligible if the claustrophobia is managed with medicatio

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Radiation

Participants receive whole brain radiation therapy (WBRT) for hematologic malignancies

Duration not specified

Standard of care visits

Neurocognitive Assessment

Participants undergo neurocognitive function assessments and complete quality-of-life questionnaires

Up to 5 years

Baseline, 2, 6, 12 months after RT completion, then annually

Follow-up

Participants are monitored for cognitive outcomes and quality-of-life changes after treatment

Up to 5 years

Annual visits

What Are the Treatments Tested in This Trial?

Interventions

• Whole Brain Radiation Therapy

How Is the Trial Designed?

Group I: Observational (neurocognitive assessment, questionnaires, MRI) Experimental Treatment 4 Interventions

Patients undergo neurocognitive function assessments, complete questionnaires over 8-10 minutes and undergo standard of care MRI at baseline (within 4 weeks before the first day of WBRT), 2, 6, 12 months after RT completion, then annually for 5 years.

Whole Brain Radiation Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Whole Brain Radiation Therapy for:

• Brain metastases

Approved in European Union as Whole Brain Radiation Therapy for:

• Brain metastases

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11527910/

Whole brain radiation therapy for patients with brain metastases Most patients with BM have a poor prognosis, with early studies having reported a median survival of approximately 1 month in patients who were ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0360301623055499

Patient Reported Outcomes Following Palliative Whole ... More than 50% of patients that survived 3 months reported a significant alleviation of pain, and 38% of patients that survived for 6 months ...

3. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-023-11675-8

Patient reported outcomes following whole brain radiotherapy ... More than 50% of patients that survived ~ 3 months reported alleviation of pain, and 38% of patients that survived for ~ 6 months reported a ...

4. surgicalneurologyint.com surgicalneurologyint.com/surgicalint-articles/stereotactic-radiosurgery-versus-whole-brain-radiotherapy-for-intracranial-metastases-a-systematic-review-and-meta-analysis/

Stereotactic radiosurgery versus whole-brain radiotherapy ... SRS and WBRT exhibited similar recurrence rates and overall survival (OS) at 1 and 5 years, with WBRT being more effective in managing post-radiation LMD.

5. apm.amegroups.org apm.amegroups.org/article/view/117598/html

Palliative whole brain radiation therapy: an international state ... Global median overall survival was 84 days after WBRT (95% confidence interval: 68.0–104.0). • Twenty-seven patients (5.8%) were unable to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6075843/

Whole-Brain Radiotherapy for Brain Metastases: Evolution or ... TOXICITY OF WBRT. Typical acute adverse effects of WBRT include temporary alopecia, mild dermatitis, mild fatigue, and less commonly otitis media or externa.

7. mdanderson.org mdanderson.org/newsroom/risks-of-whole-brain-radiation-therapy-added-to-radiosurgery-out.h00-158987445.html

Risks of whole brain radiation therapy added to ... However, none of the studies have shown a survival benefit, Brown explains. WBRT's side effects include hair loss, skin redness, dry mouth and ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1879850021001090

Critical Review Radiation Therapy for Brain Metastases We did not find systematic differences across interventions in serious adverse events, number of adverse events, radiation necrosis, fatigue, or seizures. WBRT ...

9. neurology.org neurology.org/doi/10.1212/WNL.0000000000205892

A Systematic Review and Meta-analysis (P4-5.011) SRS has been associated with better survival and local tumor control. It is a safer procedure that enhances short-term quality of life and preserves cognitive ...

10. astro.org astro.org/news-and-publications/news-and-media-center/news-releases/2024/astro24cherng

People who experience side effects from cranial radiation ... Analysis of three large, phase III clinical trials finds more than 40% of brain metastases patients completely reversed cognitive losses.