IMPT for Brain Tumor

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a specialized radiation therapy called Intensity Modulated Proton Therapy (IMPT) for treating meningiomas, which are tumors on the brain's lining. It focuses on two types: atypical meningiomas (grade II) and malignant meningiomas (grade III). The trial aims to assess the effectiveness and safety of this therapy for these conditions. Individuals with a confirmed diagnosis of these brain tumors who have undergone specific surgeries or biopsies may qualify for this study. As an unphased trial, it offers patients the chance to contribute to groundbreaking research in a specialized treatment area.

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 prior data suggests that Intensity Modulated Proton Therapy (IMPT) is safe for treating brain tumors?

Research shows that Intensity Modulated Proton Therapy (IMPT) is generally safe for treating brain tumors. Studies have found that proton beam therapy, similar to IMPT, effectively controls tumors over the long term with few side effects, especially for tumors at the base of the skull.

One study found that patients who received higher doses of proton therapy had a 92.8% rate of tumor control over five years, indicating that the treatment is effective and well-tolerated. Another study focused on IMPT for meningiomas, a type of brain tumor, and suggested that IMPT can precisely target tumors, reducing harm to healthy brain tissue.

Overall, these findings support the safety of IMPT for brain tumors, with low rates of serious side effects reported. This makes it a promising option for those considering this type of treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Intensity Modulated Proton Therapy (IMPT) because it offers a precise and powerful approach to treating brain tumors like meningiomas. Unlike traditional radiation therapies, which can affect surrounding healthy tissues, IMPT uses protons to deliver radiation directly to the tumor with pinpoint accuracy. This means less collateral damage to nearby brain tissue, potentially reducing side effects and improving patient outcomes. Additionally, IMPT's ability to modulate intensity allows for tailored treatment doses, which can be especially beneficial for complex cases or tumors located near critical brain structures. This precision and customization make IMPT a promising option for patients with Grade II and Grade III meningiomas.

What evidence suggests that Intensity Modulated Proton Therapy (IMPT) might be an effective treatment for meningioma?

Research has shown that Intensity Modulated Proton Therapy (IMPT) effectively targets brain tumors while minimizing harm to nearby healthy tissue. Studies have found that IMPT significantly lowers the radiation dose to critical areas, reducing overall exposure to normal brain tissue by 1.37 to 6.97 times. In this trial, participants with grade II meningiomas will receive IMPT at a starting dose, while those with grade III meningiomas will receive a pre-determined dose specific to their cohort. For patients with grade II or III meningiomas, the average rate of tumor control is about 52%. Additionally, for more aggressive meningiomas, the average time before the tumor grows again is about 25.7 months, with better outcomes seen in grade II tumors. IMPT's precise targeting of radiation makes it a promising option for treating complex brain tumors like meningiomas. ^{2 3 6 7 8}

Who Is on the Research Team?

Helen A Shih, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: 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 II: 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+

Published Research Related to This Trial

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]

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) 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]

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]

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) 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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0936655525001323

Effectiveness of Intensity Modulate Proton Therapy in ... IMPT significantly reduced both Dmax and Dmean for most OARs (p < 0.05) and lowered integral dose to normal brain tissue (p < 0.0001) by a factor of 1.37–6.97 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7769250/

Proton Therapy for Intracranial Meningioma for the Treatment ... For WHO grade II or III patients, the outcome of only 97 patients has been published, reporting a median tumor local control rate of 52% (range, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03180502

Study Details | NCT03180502 | Proton Beam or Intensity- ... Intensity-modulated or photon beam radiation therapy uses high-energy x-ray beams shaped to treat the tumor and may also cause less damage to normal tissue.

4. redjournal.org redjournal.org/article/S0360-3016%2824%2903525-9/fulltext

Radiation Therapy for Meningiomas – Where Do We Stand ... The reported median progression-free survival for 31 high-grade meningiomas was 25.7 months, with more favorable outcomes observed in grade 2 ...

5. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-015-0384-x

Dose-painting intensity-modulated proton therapy for ... We investigated the potential of dose-painting intensity-modulated proton beam-therapy (IMPT) for intermediate- and high-risk meningioma.

6. thegreenjournal.com thegreenjournal.com/article/S0167-8140(25)04601-8/fulltext

Prospective clinical trial of upright image-guided proton ... This study evaluates the feasibility, safety, early clinical outcomes, and dosimetric advantages of upright fixed-beamline IGAPT compared to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7066950/

Proton therapy for brain tumours in the area of evidence ... The observed 5 year local tumour control was 92.8 and 63.0% for patients treated with ≥69.6 and<69.6 Gy, respectively. Likewise, an analysis of 863 chordoma ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03180502

Study Details | NCT03180502 | Proton Beam or Intensity- ... This randomized phase II clinical trial studies the side effects and how well proton beam or intensity-modulated radiation therapy works in preserving brain ...