IMPT for Brain Tumor

Recruiting at 1 trial location

Overseen By Helen A Shih, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Investigational agents

Disqualifiers: Prior cranial irradiation, Uncontrolled illness, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is studying radiation therapy as a possible treatment for meningioma or tumor on the lining of the brain. The study drug or intervention involved in this research study is Intensity Modulated Proton Therapy (IMPT)

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot be on any other investigational drugs while participating in this study.

What data supports the effectiveness of the treatment Intensity Modulated Proton Therapy (IMPT) for brain tumors?

Research suggests that Intensity Modulated Proton Therapy (IMPT) can better target tumors while sparing healthy brain tissue, as seen in its use for other conditions like head and neck cancers and pediatric brain tumors. This means it might reduce side effects compared to traditional radiation methods. ^{1 2 3 4 5}

Is Intensity Modulated Proton Therapy (IMPT) safe for humans?

Research shows that Intensity Modulated Proton Therapy (IMPT) generally results in fewer side effects compared to traditional radiation methods, as it targets tumors more precisely and spares normal tissues. This has been observed in various conditions, including brain tumors, head and neck cancers, and lung cancer, suggesting it is generally safe for humans. ^{1 2 6 7 8}

How is Intensity Modulated Proton Therapy (IMPT) different from other treatments for brain tumors?

IMPT is unique because it can precisely target brain tumors while minimizing damage to surrounding healthy tissues, thanks to its ability to adjust the intensity and depth of proton beams. This precision is particularly beneficial for sparing critical areas like the hippocampus, which is important for memory. ^{2 3 5 7 9}

Research Team

Helen A Shih, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Adults with high-grade meningiomas, a type of brain tumor, can join this trial. They must not be pregnant or breastfeeding and agree to use contraception. Participants should have an acceptable general health status (ECOG ≤ 2) and have had certain surgeries for their tumors. Those with other cancers may qualify if they've been cancer-free for 3 years.

Inclusion Criteria

Women of child-bearing potential and all men must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of proton therapy.

My meningioma is confirmed to be atypical or malignant by a biopsy.

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

Exclusion Criteria

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

I am not pregnant or breastfeeding.

I had cancer before, but it's been 3 years and it was not likely to come back, or it was a minor skin cancer or cervical cancer in situ treated within the last 3 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Intensity Modulated Proton Therapy (IMPT) for treatment of high-grade meningiomas

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

• Intensity Modulated Proton Therapy (IMPT)

Trial Overview The trial is testing Intensity Modulated Proton Therapy (IMPT), a form of radiation therapy, as a treatment option for patients with atypical or malignant meningiomas that are WHO grade II/III after surgery.

Participant Groups

Group I: Grade III (Malignant) Meningiomas, STR Experimental Treatment 1 Intervention

Patient will be treated at a pre determined dose of Intensity Modulated Proton Therapy (IMPT) for the specific cohort.

Group II: Grade III (Malignant) Meningiomas, GTR Experimental Treatment 1 Intervention

Patient will be treated at a pre determined dose of Intensity Modulated Proton Therapy (IMPT) for the specific cohort.

Group III: Grade II (Atypical) Meningiomas, STR Experimental Treatment 1 Intervention

Patient will be treated at the starting dose of Intensity Modulated Proton Therapy (IMPT) which is pre-determined.

Intensity Modulated Proton Therapy (IMPT) is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Intensity Modulated Proton Therapy for:

• Various cancers including brain tumors, prostate cancer, pediatric cancers

Approved in European Union as Intensity Modulated Proton Therapy for:

• Various cancers including brain tumors, prostate cancer, pediatric cancers

Approved in Japan as Intensity Modulated Proton Therapy for:

• Various cancers including brain tumors, prostate cancer, pediatric cancers

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Proton therapy (IMPT) provides better dose distribution and sparing of healthy tissues compared to photon therapy (IMRT) for pediatric patients with intracranial tumors, particularly benefiting younger patients with supratentorial tumors.

Infratentorial tumors showed significant sparing of the optic chiasm with IMPT, while brainstem sparing was less pronounced, indicating that IMPT can effectively reduce radiation exposure to critical structures in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Target Location, Size, and Patient Age on Normal Tissue Sparing- Proton and Photon Therapy in Paediatric Brain Tumour Patient-Specific Approach. Dell'Oro, M., Short, M., Wilson, P., et al.[2020]

Proton radiation therapy, particularly intensity-modulated proton therapy (IMPT), offers better dose localization compared to conventional photon radiation therapy, potentially reducing damage to surrounding healthy tissues in patients with head and neck and skull base tumors.

Initial clinical experiences suggest that IMPT may lead to fewer acute and long-term toxicities, and ongoing multi-institutional trials aim to further establish its effectiveness in treating these complex tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton radiation therapy for head and neck cancer. Chan, AW., Liebsch, NJ.[2018]

Intensity modulated proton therapy (IMPT) significantly reduces the radiation dose to the hippocampus compared to volumetric modulated arc therapy (VMAT), with pediatric patients receiving a mean dose reduction from 13.7 Gy to 5.4 GyE and adults from 11.7 Gy to 4.4 GyE.

IMPT maintains equivalent target coverage while improving dose homogeneity, suggesting it may provide better protection for sensitive brain structures during whole brain radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advantages of intensity modulated proton therapy during hippocampal avoidance whole brain radiation therapy. Stoker, J., Vora, S., Patel, A., et al.[2022]

In a study of 79 patients with locally advanced non-small cell lung cancer (LA-NSCLC), intensity-modulated proton therapy (IMPT) showed similar overall survival rates compared to intensity-modulated radiation therapy (IMRT) after one year, with rates of 68% for IMPT and 65% for IMRT.

Both treatment methods resulted in low rates of severe toxicities, with only 15% of IMPT and 9% of IMRT patients experiencing grade 3 or 4 toxicities three months post-treatment, indicating that IMPT is as safe as IMRT in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Outcomes of Patients With Locally Advanced Non-small Cell Lung Cancer Treated With Intensity-Modulated Proton Therapy Versus Intensity-Modulated Radiation Therapy: The Mayo Clinic Experience. Yu, NY., DeWees, TA., Liu, C., et al.[2022]

Intensity modulated proton therapy (IMPT) was successfully used in 34 patients with lung and mediastinal cancers, showing significant improvements in sparing normal tissues compared to both intensity modulated radiation therapy (IMRT) and passive scattering proton therapy (PSPT).

IMPT achieved lower doses to critical organs like the lungs and heart while maintaining higher doses to the tumor, demonstrating effective motion management and robust treatment planning through advanced 4D CT simulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical implementation of intensity modulated proton therapy for thoracic malignancies. Chang, JY., Li, H., Zhu, XR., et al.[2022]

In a study of 163 patients with Stage III non-small cell lung cancer (NSCLC), intensity-modulated proton therapy (IMPT) significantly reduced the risk of severe pneumonitis and cardiac events compared to intensity-modulated radiation therapy (IMRT).

IMPT demonstrated better dosimetric sparing of the lungs and heart without compromising overall survival or tumor control, making it a potentially safer treatment option for patients with poor pre-treatment lung function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiopulmonary Toxicity Following Intensity-Modulated Proton Therapy (IMPT) Versus Intensity-Modulated Radiation Therapy (IMRT) for Stage III Non-Small Cell Lung Cancer. Yu, NY., DeWees, TA., Voss, MM., et al.[2023]

Intensity-modulated proton therapy (IMPT) showed significant dosimetric advantages over intensity-modulated radiotherapy (IMRT) in sparing adjacent organs at risk (OAR) in 15 out of 29 OAR for 10 patients with nasopharyngeal carcinoma.

With a median follow-up of 24.5 months, IMPT achieved a 100% locoregional control rate and an 88.9% overall survival rate, suggesting excellent clinical outcomes that warrant further investigation into potential reductions in toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated proton therapy for nasopharyngeal carcinoma: Decreased radiation dose to normal structures and encouraging clinical outcomes. Lewis, GD., Holliday, EB., Kocak-Uzel, E., et al.[2022]

Intensity modulated proton therapy (IMPT) demonstrated a high local control rate of 94% and an overall survival rate of 78% in a study of 37 patients with hepatocellular carcinoma (HCC) over a median follow-up of 21 months.

The treatment was found to be safe, with only 3% of patients experiencing significant acute toxicity, and 16% showing a minor increase in liver function scores, indicating that IMPT is a feasible option for HCC management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity Modulated Proton Therapy for Hepatocellular Carcinoma: Initial Clinical Experience. Bhangoo, RS., Mullikin, TC., Ashman, JB., et al.[2022]

Intensity-modulated proton therapy (IMPT) combined with chemotherapy showed a high clinical complete response rate of 84% in 19 patients with esophageal carcinoma, indicating its efficacy in treating this type of cancer.

With a median follow-up of 17 months, patients experienced a median overall survival of 39.2 months, and the treatment was associated with acceptable levels of acute toxicity, primarily esophagitis and fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of intensity modulated proton therapy and concurrent chemotherapy in esophageal carcinoma: a single institutional experience. Prayongrat, A., Xu, C., Li, H., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Influence of Target Location, Size, and Patient Age on Normal Tissue Sparing- Proton and Photon Therapy in Paediatric Brain Tumour Patient-Specific Approach. [2020]

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

Proton radiation therapy for head and neck cancer. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Advantages of intensity modulated proton therapy during hippocampal avoidance whole brain radiation therapy. [2022]

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

Early Outcomes of Patients With Locally Advanced Non-small Cell Lung Cancer Treated With Intensity-Modulated Proton Therapy Versus Intensity-Modulated Radiation Therapy: The Mayo Clinic Experience. [2022]

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

Clinical implementation of intensity modulated proton therapy for thoracic malignancies. [2022]

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

Cardiopulmonary Toxicity Following Intensity-Modulated Proton Therapy (IMPT) Versus Intensity-Modulated Radiation Therapy (IMRT) for Stage III Non-Small Cell Lung Cancer. [2023]

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

Intensity-modulated proton therapy for nasopharyngeal carcinoma: Decreased radiation dose to normal structures and encouraging clinical outcomes. [2022]

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

Intensity Modulated Proton Therapy for Hepatocellular Carcinoma: Initial Clinical Experience. [2022]

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

Clinical outcomes of intensity modulated proton therapy and concurrent chemotherapy in esophageal carcinoma: a single institutional experience. [2022]