Genu-Sparing Whole Brain Radiation for Brain Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Kristin Redmond, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Prior WBRT, MMSE<24, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a trial that evaluates the preservation of cognition and neuropsychiatric function following genu-sparing whole brain radiation in patients with brain metastases.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Genu-Sparing Whole Brain Radiation Therapy for brain cancer?

Research shows that sparing the hippocampus during whole brain radiation therapy can help reduce cognitive decline (problems with thinking and memory) in patients with brain metastases. This approach, known as Hippocampal Avoidance Whole Brain Radiation Therapy, is considered effective in maintaining cognitive function while treating brain cancer.

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Is Genu-Sparing Whole Brain Radiation Therapy safe for humans?

Hippocampal-sparing whole brain radiation therapy, which is similar to genu-sparing, is generally considered safe and aims to reduce memory and cognitive side effects compared to traditional whole brain radiation. Studies have shown it may prevent treatment-related cognitive decline, and technological advances have improved its safety profile.

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What makes Genu-Sparing Whole Brain Radiation Therapy unique compared to other treatments for brain cancer?

Genu-Sparing Whole Brain Radiation Therapy is unique because it aims to protect the hippocampus (a part of the brain important for memory) during radiation treatment, potentially reducing memory decline, which is a common side effect of traditional whole brain radiation therapy.

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Eligibility Criteria

This trial is for adults over 18 with brain metastases who can consent to treatment, have a performance status score of ≥70, and are expected to live at least 6 more months. They must be able to use contraception and have not had whole brain radiation before. Non-English speakers, those with serious illnesses preventing protocol adherence or MRI contraindications, are excluded.

Inclusion Criteria

My cancer diagnosis is confirmed by lab tests on tissue or fluid samples.

I am able to care for myself but may not be able to do active work.

Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child

Exclusion Criteria

You cannot have an MRI due to a serious medical reason.

I have cancer that has spread to a specific part of my brain.

I have had whole brain radiation therapy before.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive genu-sparing whole brain radiation therapy (GS-WBRT) with a standard dose of 3000 cGy in 10 fractions

3-4 weeks

10 visits (in-person)

Follow-up

Participants undergo cognitive testing at baseline and at 4, 6, and 12 months following completion of brain radiation to evaluate cognitive function and quality of life

12 months

3 visits (in-person)

Participant Groups

The study tests genu-sparing whole brain radiation therapy (WBRT) aimed at preserving cognitive and neuropsychiatric functions in patients with brain metastases. It's designed for those who've possibly undergone prior stereotactic radiosurgery but haven't received WBRT.

Group I: Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy Experimental Treatment 1 Intervention

Genu-sparing whole brain radiation therapy (GS-WBRT) 30 Gy in 3 Gy per fraction

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

🇺🇸 Approved in United States as Genu-Sparing Whole Brain Radiation Therapy for:

• Brain metastases

🇪🇺 Approved in European Union as Hippocampal Avoidance Whole Brain Radiation Therapy for:

• Brain metastases
• Limited brain metastases

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins Baltimore, MD

Sibley Memorial Hospital Washington, United States

The SKCCC at Johns Hopkins Baltimore, MD

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Lead Sponsor

References

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

Dosimetric evaluation of intensity-modulated radiotherapy, volumetric modulated arc therapy, and helical tomotherapy for hippocampal-avoidance whole brain radiotherapy. [2022] Whole brain radiotherapy (WBRT) is a vital tool in radiation oncology and beyond, but it can result in adverse health effects such as neurocognitive decline. Hippocampal Avoidance WBRT (HA-WBRT) is a strategy that aims to mitigate the neuro-cognitive side effects of whole brain radiotherapy treatment by sparing the hippocampi while delivering the prescribed dose to the rest of the brain. Several competing modalities capable of delivering HA-WBRT, include: Philips Pinnacle step-and-shoot intensity modulated radiotherapy (IMRT), Varian RapidArc volumetric modulated arc therapy (RapidArc), and helical TomoTherapy (TomoTherapy).

2. England pubmed.ncbi.nlm.nih.gov

Evaluating the Heterogeneity of Hippocampal Avoidant Whole Brain Radiotherapy Treatment Effect: A Secondary Analysis of NRG CC001. [2023] Hippocampal avoidant whole brain radiotherapy (HA-WBRT) is the standard of care for patients needing WBRT for brain metastases (BM). This study, using existing data from NRG Oncology CC001 including baseline tumor characteristics and patient-reported MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) scores, sought to identify subgroups of patients that demonstrate differential neuroprotective treatment response to HA-WBRT.

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

Incidence of Hippocampal Metastases: Laterality and Implications for Unilateral Hippocampal Avoiding Whole Brain Radiotherapy. [2022] Hippocampi sparing whole brain radiotherapy (WBRT) is an evolving approach in the treatment of patients with multiple brain metastases, pursuing mitigation of verbal memory decline as a consequence of hippocampal radiation injury. Accumulating data are showing different postradiotherapy changes in the left and right hippocampus with a theoretical proposal of only unilateral (dominant, left) hippocampal sparing during WBRT.

4. Germany pubmed.ncbi.nlm.nih.gov

Whole brain irradiation with hippocampal sparing and dose escalation on multiple brain metastases: Local tumour control and survival. [2022] Hippocampal-avoidance whole brain radiotherapy (HA-WBRT) for multiple brain metastases may prevent treatment-related cognitive decline, compared to standard WBRT. Additionally, simultaneous integrated boost (SIB) on individual metastases may further improve the outcome. Here, we present initial data concerning local tumour control (LTC), intracranial progression-free survival (PFS), overall survival (OS), toxicity and safety for this new irradiation technique.

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

Hippocampal-sparing whole-brain radiotherapy: a "how-to" technique using helical tomotherapy and linear accelerator-based intensity-modulated radiotherapy. [2022] Sparing the hippocampus during cranial irradiation poses important technical challenges with respect to contouring and treatment planning. Herein we report our preliminary experience with whole-brain radiotherapy using hippocampal sparing for patients with brain metastases.

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

Hippocampal-Sparing Whole-Brain Radiotherapy for Lung Cancer. [2022] Brain metastases occur in 20% to 40% of lung cancer patients. Whole-brain radiotherapy (WBRT) has long been considered the treatment of choice for many patients with lung cancer, because of its wide availability, ease of delivery, and effectiveness in prolonging survival. However, WBRT is also associated with several side effects, such as decline in memory and other cognitive functions. There exists significant preclinical and clinical evidence that radiation-induced injury to the hippocampus correlates with neurocognitive decline of patients who receive WBRT. Technological advances in treatment planning and delivery facilitate the use of hippocampal-sparing (HS) WBRT as prophylactic cranial irradiation or the primary treatment modality for lung cancer patients with brain metastases. In this review, we provide a detailed and comprehensive discussion of the safety profile, techniques for hippocampus-sparing, and the clinical evidence of HS-WBRT for lung cancer patients.

7. Thailand pubmed.ncbi.nlm.nih.gov

Hippocampal Sparing Whole Brain Radiotherapy and Integrated Simultaneous Boost vs Stereotactic Radiosurgery Boost: A Comparative Dosimetric Planning Study. [2017] Whole brain radiotherapy (WBRT) and stereotactic radiosurgery were frequently used to palliate patients with brain metastases. It remains controversial which modality or combination of therapy is superior especially in the setting of limited number of brain metastases. The availability of newer medical therapy that improves survival highlighted the importance of reducing long term radiation toxicity associated with WBRT. In this study, we aim to demonstrate the hippocampal sparing technique with whole brain and integrated simultaneous boost Materials and Methods: Planning data from 10 patients with 1-5 brain metastases treated with SRS were identified. Based on the contouring guideline from RTOG atlas, we identified and contoured the hippocampus with 5mm isocentric expansion to form the hippocampal avoidance structure. The plan was to deliver hippocampal sparing whole brain radiotherapy (HSWBRT) of 30 Gy in 10 fractions and simultaneous boost to metastatic lesions of 30 Gy in 10 fractions each.