Targeted Radiation Therapy for Brain Cancer

(CogRT Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Sahaja Acharya, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Pregnancy, Down's syndrome, Autism, others

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this trial is to determine whether it is possible to minimize radiation dose to parts of the brain that are important for thinking and learning in children who require radiation to treat their tumor, and if this will help reduce neurocognitive (thinking and learning) impairments in these patients. Patients with newly diagnosed brain or head and neck tumors who are having radiation therapy will have neurocognitive testing and MRI imaging (both research and for regular care) done as part of their participation in the study. Survivors of childhood brain tumors who completed radiation therapy at least two years before joining the study, and have not had a recurrence, will have neurocognitive testing and research MRIs completed. Healthy children will also be enrolled and have research MRIs done. The researchers will use the radiation plan to determine how much radiation was delivered to different parts of the brain. The investigators will use the MRIs to determine how the normal brain is changing after treatment; and how this compares to patients who had standard radiation treatment or who never had a brain tumor. The neurocognitive testing will be compared among different groups to see how different treatment plans affect performance on neurocognitive tests.

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 coordinators or your doctor.

What data supports the effectiveness of the treatment Targeted Radiation Therapy for Brain Cancer?

Research shows that advanced radiation techniques like stereotactic radiosurgery (SRS) and intensity-modulated radiotherapy (IMRT) are effective in treating brain tumors by precisely targeting cancer cells while sparing healthy tissue. These methods have been used successfully for brain metastases and other brain tumors, suggesting potential benefits for primary brain cancer as well. ^{1 2 3 4 5}

Is targeted radiation therapy generally safe for humans?

Research shows that targeted radiation therapies like image-guided radiation therapy (IGRT) and intensity-modulated radiation therapy (IMRT) are generally safe, with improvements in safety and reduced side effects over time. These therapies are used in various conditions, including prostate cancer, and have been shown to decrease acute toxicities (short-term side effects) compared to older methods. ^{6 7 8 9 10}

How is targeted radiation therapy different from other treatments for brain cancer?

Targeted radiation therapy for brain cancer is unique because it focuses radiation precisely on the tumor, minimizing damage to surrounding healthy brain tissue. This approach includes advanced techniques like stereotactic radiosurgery and intensity-modulated radiotherapy, which allow for more accurate targeting compared to traditional methods. ^{1 2 3 11 12}

Research Team

Sahaja Acharya, MD

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria

This trial is for children and young adults aged 1 to <26 with new brain or head and neck tumors needing radiation therapy. It includes those who finished radiation at least two years ago without recurrence, and healthy kids for comparison.

Inclusion Criteria

I am between 5 and 25 years old and can undergo imaging tests without needing sedation.

I was diagnosed with a brain tumor before 26, had brain radiation over 2 years ago, and my tumor hasn't come back since.

I am between 1 and 25 years old with a brain tumor receiving radiation therapy.

Exclusion Criteria

STRATUM B: Inability to undergo neuro-cognitive testing, including children lacking English comprehension or with premorbid neurological/neurodevelopmental disorders such as Down's syndrome or autism

I am not pregnant, can undergo brain function tests, and do not have conditions like Down's syndrome or autism.

I have a major psychiatric, neurologic, or medical condition.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Patients undergo radiation therapy planned according to dose constraints to specific brain substructures

1 month

Neurocognitive Testing and MRI

Neurocognitive testing and MRI imaging are conducted to assess brain changes and cognitive outcomes

baseline to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of tumor recurrence and cognitive outcomes

up to 5 years

Treatment Details

Interventions

• Radiation Therapy (Radiation Therapy)

Trial Overview The study tests if targeting radiation more precisely to protect brain areas important for thinking can reduce learning impairments. Participants undergo neurocognitive testing and MRI scans to assess the impact of different radiation plans.

Participant Groups

Group I: Stratum C (healthy controls matched to Stratum A) Experimental Treatment 2 Interventions

Healthy patients who are matched to Stratum A patients

Group II: Stratum B (patients ≥ 2 years after standard radiation therapy) Experimental Treatment 2 Interventions

Patients who completed radiation therapy under standard planning procedures ≥ 2 years ago.

Group III: Stratum A (new diagnosis, substructure informed radiation therapy) Experimental Treatment 3 Interventions

Patients will undergo radiation therapy which has been planned according to dose constraints to specific brain substructures.

Radiation Therapy is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Sibley Memorial Hospital Washington, United States

Johns Hopkins Hospital Baltimore, MD

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Patients Recruited

33,600+

United States Department of Defense

Collaborator

Trials

940

Patients Recruited

339,000+

Clark Charitable Foundation

Collaborator

Trials

2

Patients Recruited

410+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation techniques in neuro-oncology. Khuntia, D., Tomé, WA., Mehta, MP.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical and health economic assessment of radiosurgery for the treatment of brain metastasis. Müller-Riemenschneider, F., Schwarzbach, C., Bockelbrink, A., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving radiotherapy for brain tumors. Woo, SY., Maor, MH.[2005]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated stereotactic radiotherapy vs. stereotactic conformal radiotherapy for the treatment of meningioma located predominantly in the skull base. Baumert, BG., Norton, IA., Davis, JB.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of image-guided radiotherapy for locally advanced rectal cancer. Nguyen, NP., Ceizyk, M., Almeida, F., et al.[2011]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. Qi, XS., Albuquerque, K., Bailey, S., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased acute toxicities of intensity-modulated radiation therapy for localized prostate cancer with prostate-based versus bone-based image guidance. Nakamura, K., Mizowaki, T., Inokuchi, H., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxicity and patient-reported symptom score after conventional versus moderately hypofractionated proton therapy for prostate cancer. Iizumi, T., Ishikawa, H., Sekino, Y., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in toxicity in high risk prostate cancer patients treated with image-guided intensity-modulated radiotherapy compared to 3D conformal radiotherapy without daily image guidance. Sveistrup, J., af Rosenschöld, PM., Deasy, JO., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of acute and chronic toxicity for men with low-risk prostate cancer treated with intensity-modulated radiation therapy or (125)I permanent implant. Eade, TN., Horwitz, EM., Ruth, K., et al.[2022]

Radiotherapy is an important treatment option for both malignant and benign intracranial tumors, often used alongside neurosurgery to improve outcomes.

Stereotactic radiosurgery, particularly using gamma knife technology, is a highly precise method for irradiating tumors and is increasingly combined with systemic therapies to effectively treat metastatic lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiosurgical techniques for the treatment of brain neoplasms: A short review. Velnar, T., Bosnjak, R.[2020]

Targeted radiotherapy presents a promising alternative to traditional external beam radiotherapy for malignant brain tumors, as it aims to increase the precision of radiation delivery to tumor cells while minimizing damage to surrounding healthy brain tissue.

This approach could potentially enhance treatment efficacy by focusing on tumor cells specifically, reducing the risk of adverse effects associated with excessive radiation exposure to normal central nervous system tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted radiotherapy of brain tumours. Zalutsky, MR.[2022]

References

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

Radiation techniques in neuro-oncology. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Medical and health economic assessment of radiosurgery for the treatment of brain metastasis. [2021]

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

Improving radiotherapy for brain tumors. [2005]

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

Intensity-modulated stereotactic radiotherapy vs. stereotactic conformal radiotherapy for the treatment of meningioma located predominantly in the skull base. [2022]

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

Effectiveness of image-guided radiotherapy for locally advanced rectal cancer. [2011]

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

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]

7. Japan pubmed.ncbi.nlm.nih.gov

Decreased acute toxicities of intensity-modulated radiation therapy for localized prostate cancer with prostate-based versus bone-based image guidance. [2018]

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

Acute toxicity and patient-reported symptom score after conventional versus moderately hypofractionated proton therapy for prostate cancer. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Improvement in toxicity in high risk prostate cancer patients treated with image-guided intensity-modulated radiotherapy compared to 3D conformal radiotherapy without daily image guidance. [2021]

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

A comparison of acute and chronic toxicity for men with low-risk prostate cancer treated with intensity-modulated radiation therapy or (125)I permanent implant. [2022]

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

Radiosurgical techniques for the treatment of brain neoplasms: A short review. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Targeted radiotherapy of brain tumours. [2022]