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

29 Participants Needed

Trial Summary

What is the purpose of this trial?

Some cancers can spread, or metastasize, to the brain. When they do, treatment often involves surgery and/or radiation. Optimal treatment of brain metastases would maximize disease control and minimize toxicity (or side effects), and improve the quality of life of patients. A common type of radiation used for brain metastases is called whole brain radiation, which treats not just the cancer that can be seen on scans (i.e., gross disease), but the smaller sites of cancer that may not be visible (i.e. subclinical disease). Fractionation is used to describe repetitive treatments in which small doses (fractions) of a total planned dose are given at separate clinic visits. The most common dosing regimen is 30 Gray (Gy), using 3 Gy per fraction over 10 fractions. Previous studies have suggested that using intensity modulated radiation therapy (IMRT) may be a safer way to deliver higher doses to gross disease and lower doses to the rest of the brain that may contain subclinical disease. This approach may spare the rest of the brain from radiation complications and side effects. The goal of this study is to determine whether using IMRT to treat brain metastases is more effective than current standard whole brain radiation in controlling gross disease and whether patient quality of life and hair loss is improved compared to previous studies using whole brain radiation.

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 data supports the effectiveness of the treatment Intensity Modulated Radiotherapy (IMRT) for brain cancer?

Research shows that IMRT can closely target brain tumors while sparing healthy tissue, potentially reducing side effects and improving tumor control. Studies on high-grade gliomas, a type of brain cancer, suggest that IMRT may enhance tumor response and control compared to other radiotherapy methods. ^{1 2 3 4 5}

Is intensity-modulated radiotherapy (IMRT) generally safe for humans?

IMRT is generally considered safe for humans, as it allows precise targeting of radiation to minimize exposure to healthy tissues. However, it is complex and requires careful planning and safety checks to prevent errors or machine malfunctions that could lead to serious accidents. ^{3 6 7 8 9}

How does the treatment IMRT for brain cancer differ from other treatments?

Intensity Modulated Radiotherapy (IMRT) is unique because it allows for precise targeting of brain tumors, delivering radiation that closely conforms to the shape of the tumor while minimizing exposure to surrounding healthy tissue. This precision helps to spare organs at risk and reduce side effects compared to traditional radiotherapy methods. ^{2 3 8 10 11}

Research Team

Ben Liem, MD

Principal Investigator

University of New Mexico Comprehensive Cancer Center

Eligibility Criteria

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

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.

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

Exclusion Criteria

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

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

Contraindication to Magnetic Resonance (MR) imaging

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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) 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]

References

1. United States 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? [2022]

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

Comparison of intensity-modulated tomotherapy with stereotactically guided conformal radiotherapy for brain tumors. [2019]

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

Intensity-modulated radiotherapy in high-grade gliomas: clinical and dosimetric results. [2019]

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

Simultaneous integrated boost intensity-modulated radiotherapy in patients with high-grade gliomas. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Intensity modulated radiotherapy (IMRT) decreases treatment-related morbidity and potentially enhances tumor control. [2019]

6. Italy pubmed.ncbi.nlm.nih.gov

Oral complications of head and neck radiotherapy: prevalence and management. [2017]

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

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

8. England pubmed.ncbi.nlm.nih.gov

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

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

Safety considerations for IMRT: executive summary. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Dosimetric investigation of whole-brain radiotherapy with helical intensity modulated radiation therapy and volumetric modulated arc therapy for scalp sparing. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Clinical use of intensity-modulated radiotherapy: part I. [2005]