IMRT for Brain Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New Mexico Cancer Care Alliance

Must not be taking: Chemotherapy, Targeted therapies

Disqualifiers: Leptomeningeal metastases, Brainstem involvement, others

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

Compensation: Varies

Number of Visits: 15

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat brain cancer that has spread from other parts of the body. It focuses on intensity modulated radiation therapy (IMRT), which targets tumors with high doses while minimizing harm to healthy brain tissue. Researchers aim to determine if this method better controls cancer and improves quality of life compared to the current standard, which treats the whole brain. Suitable candidates for this trial have multiple brain tumors from non-blood-related cancers and have not received prior radiation therapy to the brain, except for radiosurgery. As an unphased trial, this study offers patients the chance to contribute to innovative research that could lead to improved treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot have chemotherapy or targeted therapies during the radiation treatment or within one week after finishing it.

What prior data suggests that this method is safe for treating brain metastases?

Research has shown that Intensity Modulated Radiotherapy (IMRT) is generally safe for treating brain metastases. IMRT delivers high doses of radiation directly to cancerous areas while minimizing exposure to healthy brain tissue. This precision often results in fewer side effects compared to traditional whole brain radiation.

Previous studies found that IMRT is well-tolerated, with low levels of radiation-related side effects. Patients usually experience fewer negative effects from the treatment. Although these studies do not demonstrate improved survival rates, they confirm the safety of IMRT in targeting tumors.

Overall, IMRT offers a promising option for those considering radiation therapy for brain metastases, focusing on safety and reducing side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard brain cancer treatments that involve traditional radiotherapy, Intensity Modulated Radiotherapy (IMRT) offers a more precise approach. IMRT is unique because it can deliver varying intensities of radiation, allowing for higher doses to target the tumor more accurately while sparing surrounding healthy tissue. Researchers are excited about this approach because it has the potential to reduce side effects and improve the overall effectiveness of treatment by focusing radiation on the cancerous areas more precisely. This precision not only enhances the potential for better outcomes but also maintains a higher quality of life for patients during treatment.

What evidence suggests that IMRT is effective for brain cancer?

Research has shown that Intensity Modulated Radiotherapy (IMRT), the treatment under study in this trial, effectively treats brain cancer. Studies indicate that IMRT controls cancer in the treated area with a 96% success rate over two years. It targets the tumor more precisely while reducing radiation to healthy brain areas, which helps lower the risk of complications and side effects. Other studies have also found that IMRT reduces radiation to critical brain areas like the brainstem and the optic chiasm, potentially leading to fewer side effects and a better quality of life for patients. ^{1 4 6 7 8}

Who Is on the Research Team?

Ben Liem, MD

Principal Investigator

University of New Mexico Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a performance status indicating they can care for themselves and are not bedridden. They must understand the study, consent to it, use birth control if of childbearing potential, and have a negative pregnancy test. Participants should have multiple brain metastases from solid tumors (excluding small cell lung cancer and germ cell malignancy) diagnosed within the last five years.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

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

I had surgery for brain metastases and still have some cancer seen on an MRI.

Exclusion Criteria

I have cancer that has spread to the lining of my brain and spinal cord.

Contraindication to Magnetic Resonance (MR) imaging

I am scheduled for chemotherapy or targeted therapy during or right after brain radiation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Intensity Modulated Radiotherapy (IMRT) is delivered to a dose of 60 Gray (Gy)/45 Gy to gross disease and 30 Gy to subclinical sites over 15 fractions

3 weeks

15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of memory and alopecia

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Intensity Modulated Radiotherapy

Trial Overview

The trial tests Intensity Modulated Radiotherapy (IMRT) as an alternative to standard whole brain radiation for patients with brain metastases from primary cancers. It aims to see if IMRT better controls visible tumors while reducing side effects like hair loss and improving quality of life.

How Is the Trial Designed?

Group I: Intensity Modulated Radiotherapy (IMRT) Experimental Treatment 1 Intervention

Radiation therapy to a dose of 60 Gray (Gy)/45 Gy to gross disease and 30 Gy to subclinical sites, delivered over 15 fractions

Who Is Running the Clinical Trial?

New Mexico Cancer Care Alliance

Lead Sponsor

Trials

71

Recruited

52,500+

New Mexico Cancer Research Alliance

Lead Sponsor

Trials

71

Recruited

52,500+

Published Research Related to This Trial

Intensity Modulated Radiation Therapy (IMRT) is now the primary technique for delivering radiation treatment, allowing for higher doses to be targeted precisely while protecting surrounding healthy tissue.

The updated consensus emphasizes the importance of quality and safety in IMRT planning and delivery, requiring a team-based approach and comprehensive quality assurance programs to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Intensity Modulated Radiation Therapy: An ASTRO Safety White Paper Update. Moran, JM., Bazan, JG., Dawes, SL., et al.[2023]

Intensity-modulated radiotherapy (IMRT) for high-grade gliomas improves target conformity and reduces radiation exposure to critical normal tissues compared to conventional three-dimensional conformal radiotherapy (3D-CRT), with significant dose reductions for structures like the optic nerves and brainstem.

IMRT achieves these benefits without increasing the total integral dose to nontarget tissues by more than 0.5%, resulting in an overall reduction of 7-10% in integral dose, which is crucial for minimizing potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy (IMRT) and conventional three-dimensional conformal radiotherapy for high-grade gliomas: does IMRT increase the integral dose to normal brain? Hermanto, U., Frija, EK., Lii, MJ., et al.[2022]

Intensity-modulated radiotherapy (IMRT) has been shown to significantly reduce toxicity-related side effects compared to conventional radiotherapy in various cancers, including head and neck and breast cancers, based on evidence from 61 studies involving over 7,000 patients.

IMRT not only maintains better quality of life by preserving functions like saliva production in head and neck cancer patients but also allows for safer dose escalation in prostate cancer, indicating its efficacy in improving treatment outcomes across multiple tumor sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the clinical evidence for intensity-modulated radiotherapy. Staffurth, J.[2022]

The study compared intensity-modulated radiotherapy (IMRT) using the Peacock system with stereotactically guided conformal radiotherapy (SCRT) in five patients with medium-sized convex-shaped brain tumors, finding that IMRT provided slightly better planning target volume (PTV) coverage.

While the doses to organs at risk (OAR) were higher with the Peacock method, all doses remained below clinically acceptable thresholds, indicating that IMRT can be a safe option for treating these tumors, though further improvements in planning methods may enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of intensity-modulated tomotherapy with stereotactically guided conformal radiotherapy for brain tumors. Khoo, VS., Oldham, M., Adams, EJ., et al.[2019]

In a study of 20 patients undergoing intensity-modulated radiotherapy (IMRT) for head and neck cancer, acute side effects were common, with 19 patients experiencing xerostomia (dry mouth) and 18 reporting mucositis (inflammation of the mucous membranes).

Long-term effects included persistent xerostomia in 11 out of 14 patients and an increase in trismus (restricted jaw movement) in 4 patients, indicating that while some acute symptoms improved, certain complications remained significant after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral complications of head and neck radiotherapy: prevalence and management. Germano, F., Melone, P., Testi, D., et al.[2017]

Intensity modulated radiation therapy (IMRT) has shown promising results in treating various tumors, including prostate, head and neck, and brain cancers, based on a retrospective review of 185 patients.

IMRT not only effectively targets tumors while minimizing damage to surrounding healthy tissues, but it also allows for dose escalation, which can improve tumor control and reduce treatment-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity modulated radiotherapy (IMRT) decreases treatment-related morbidity and potentially enhances tumor control. Teh, BS., Mai, WY., Grant, WH., et al.[2019]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3097603/

Intensity modulated radiotherapy: advantages, limitations ...

The 2-year local control and overall survival reported are 96% and 92 %, respectively. Excellent short-term results have also been achieved by other centres ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5722415/

Intensity modulated radiation therapy versus three ...

In the present study, IMRT improved tumor coverage and simultaneously reduced radiation dose to the normal brain, brainstem, and optic chiasm. Data comparing ...

3.

ro-journal.biomedcentral.com

ro-journal.biomedcentral.com/articles/10.1186/1748-717X-2-26

Standard fractionation intensity modulated radiation therapy ...

Median survival was 8.7 months, with 37 patients (88%) deceased at last contact. Nonparametric analysis showed no survival difference in IMRT-boost vs. IMRT- ...

4.

bcbsri.com

bcbsri.com/providers/sites/providers/files/policies/2024/07/2023%20DRAFT%20UPDATE%20Intensity-Modulated%20Radiotherapy.Effective.10.1.24.pdf

Intensity-modulated radiotherapy (IMRT) has been ...

For individuals who have benign brain tumors who receive IMRT, the evidence includes case series. Relevant outcomes are OS, DSS, functional outcomes, and ...

5.

ascopubs.org

ascopubs.org/doi/10.1200/jco.2004.22.90140.1532

Intensity modulated radiotherapy in high grade gliomas

However, the use of IMRT resulted in a decreased dose to spinal cord, optic chiasm and brain stem by 19%, 4.5% and 8% respectively due to its improved dose ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00328575

Using Intensity Modulated Radiation Therapy (IMRT) for ...

IMRT is capable of generating complex 3-D dose distribution to conform closely to the target volume by modulating the radiation beam.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3473526/

The developing role for intensity-modulated radiation therapy ...

Recent literature has demonstrated the safety and efficacy of delivering very high focal doses of radiation (by radiosurgical techniques) to the gross tumour ...

8.

bcbsm.com

bcbsm.com/amslibs/content/dam/public/mpr/mprsearch/pdf/2047282.pdf

INTENSITY MODULATED RADIATION THERAPY (IMRT)

Case series results have consistently shown low radiation toxicity but have not demonstrated better tumor control or improved survival with ...