Proton Radiation Therapy for Acoustic Neuroma

Overseen By Tarin Grillo

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: ARBs, ACE inhibitors, Ototoxic drugs

Disqualifiers: Tumors > 3cm, Uncontrolled illness, Pregnancy, HIV, Major ear disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

In this research study we are looking at another type of radiation called proton radiation which is known to spare surrounding normal tissues from radiation. The proton radiation will be delivered using fractionated stereotactic radiotherapy (FSRT) to improve localization of the small tumor target. Proton radiation delivers minimal radiation beyond the area of the tumor. This may reduce side effects that patients would normally experience with conventional radiation therapy. In this research study, we are looking to determine the effects of fractionated proton radiotherapy on long-term hearing preservation and controlling tumor growth.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on losartan, other angiotensin II type I receptor blockers, ACE inhibitors, or medications known to cause ototoxicity (harm to the ear).

Is proton radiation therapy safe for humans?

Proton radiation therapy has been studied for treating acoustic neuromas, and while it aims to control tumors and preserve hearing, there can be complications like hearing loss. Safety data suggests that while it is generally safe, there is a risk of side effects such as cranial nerve injuries and hearing issues, which should be monitored. ^{1 2 3 4 5}

How is fractionated proton radiation therapy different from other treatments for acoustic neuroma?

Fractionated proton radiation therapy for acoustic neuroma is unique because it uses precise proton beams to target the tumor, which helps in preserving hearing and minimizing damage to surrounding nerves. This approach allows for better control of the tumor while reducing the risk of complications compared to traditional radiation therapies. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Fractionated proton radiation for Acoustic Neuroma?

Research shows that fractionated proton radiation therapy is effective in controlling tumor growth and preserving hearing in patients with acoustic neuroma, with studies indicating successful outcomes in maintaining tumor control and minimizing complications. ^{1 2 3 6 7}

Who Is on the Research Team?

Helen A Shih, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults with measurable vestibular schwannoma who have 'useful hearing' and a life expectancy over 5 years. They must not have had prior radiotherapy near the internal acoustic canal, be on certain blood pressure medications, or have major ear diseases. Participants need to agree to use contraception and undergo regular hearing tests.

Inclusion Criteria

I can breathe through my nose while using a special device that keeps my head still.

Willing and able to comply with comprehensive audiologic testing, at baseline prior to radiation therapy, at 6 months from treatment completion, and at annual timepoints for 5 years after completion

Your blood pressure should be above 100 mm Hg when measured while sitting and resting. If it's below 110 mm Hg, we may check the other arm as well. If we check both arms, we'll use the higher value to calculate the average.

Exclusion Criteria

You have had a bad reaction to radiotherapy in the past.

My tumor is larger than 3cm.

I am not currently taking losartan, any ARB, or ACE inhibitor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Proton radiation delivered daily using fractionated stereotactic radiotherapy (FSRT) for approximately 5.5 weeks

5.5 weeks

Daily visits for radiation

Follow-up

Participants are monitored for safety and effectiveness after treatment, with visits 6 months after treatment and annually for 5 years

5 years

1 visit at 6 months, annual visits for 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Fractionated proton radiation

Trial Overview The study is testing fractionated proton radiation therapy's ability to preserve hearing in patients with vestibular schwannoma while controlling tumor growth. Proton radiation aims to minimize damage to surrounding tissues compared to conventional therapies.

How Is the Trial Designed?

Group I: Fractionated Proton Radiation Experimental Treatment 2 Interventions

Single arm study, delivering fractionated radiation with a technique (proton therapy) that may be associated with reduced side effects

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+

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

Long-term results of stereotactic proton beam radiotherapy for acoustic neuromas. [2021]

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

Fractionated Proton Beam Therapy for Acoustic Neuromas: Tumor Control and Hearing Preservation. [2022]

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

Long-Term Outcomes of Fractionated Stereotactic Proton Therapy for Vestibular Schwannoma: A Case Series. [2022]

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

Fractionated proton beam radiotherapy for acoustic neuroma. [2019]

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

Twenty years' experience in the treatment of acoustic neuromas with fractionated radiotherapy: a review of 45 cases. [2018]

6. Ireland pubmed.ncbi.nlm.nih.gov

Cochlear-optimized treatment planning in photon and proton radiosurgery for vestibular schwannoma patients. [2023]

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

A Rare Case of Unilateral Auditory Neuropathy Induced by Proton Therapy. [2023]