Proton Radiation Therapy for Acoustic Neuroma

TG
Overseen ByTarin Grillo
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using radiation to treat acoustic neuroma, a type of non-cancerous brain tumor. The focus is on fractionated proton radiation, designed to precisely target the tumor and minimize damage to surrounding healthy tissues. The goal is to determine if this method can better preserve hearing and control tumor growth compared to standard treatments. Eligible participants have a confirmed acoustic neuroma, have not received radiation treatment near their ear, and still maintain useful hearing in the affected ear. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of people.

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).

What prior data suggests that fractionated proton radiation is safe for treating acoustic neuroma?

Research has shown that fractionated proton radiation therapy is generally safe and well-tolerated. Studies have found that this treatment effectively controls tumor growth while minimizing side effects. For instance, one study found that patients with vestibular schwannomas (a type of non-cancerous brain tumor) who received this therapy experienced good tumor control with fewer side effects compared to traditional radiation treatments. Another study reported similar results, noting that patients handled the therapy well. Overall, fractionated proton radiation appears to be a promising and safe option for treating conditions like acoustic neuroma.12345

Why do researchers think this study treatment might be promising?

Fractionated proton radiation therapy is unique because it uses proton beams instead of traditional X-rays to target acoustic neuromas. Researchers are excited about this treatment because it may reduce side effects compared to conventional radiation therapy. Unlike standard treatments, which often affect surrounding healthy tissues, proton therapy delivers radiation more precisely, potentially sparing nearby structures and leading to fewer complications.

What evidence suggests that fractionated proton radiation is effective for acoustic neuroma?

Research has shown that fractionated proton radiation therapy effectively treats acoustic neuroma, a type of non-cancerous brain tumor. Studies have found that this treatment successfully controls the tumor, with success rates between 84% and 100%. This method also has few side effects, particularly in protecting important nerves, including those related to hearing. Patients receiving this treatment preserve their hearing better compared to traditional radiation methods. Overall, fractionated proton radiation therapy shows promise for managing tumor growth while minimizing side effects.26789

Who Is on the Research Team?

Member Detail - DF/HCC

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.
See 9 more

Exclusion Criteria

You have had a bad reaction to radiotherapy in the past.
I am not taking any medications known to affect hearing.
My tumor is larger than 3cm.
See 8 more

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?
1Treatment groups
Experimental Treatment
Group I: Fractionated Proton RadiationExperimental Treatment2 Interventions

Find a Clinic Near You

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

Fractionated Proton Beam Therapy for Acoustic NeuromasFractionated proton therapy of 50.4 Gy offers excellent local control and minimal cranial nerve toxicities. Improved rates of hearing preservation
Long-Term Outcomes of Fractionated Stereotactic Proton ...The reported tumor control rate for VS treated with definitive fractionated radiotherapy in a large series ranges from 84% to 95% [14, 15, 23, 24].
Effectiveness and Toxicity of Fractionated Proton Beam ...These data demonstrate excellent effectiveness with 100% local control in a median follow-up period of 3.6 years with a promising cranial nerve functional ...
Hearing Outcomes Using Fractionated Proton Radiation ...In this research study, we are looking to determine the effects of fractionated proton radiotherapy on long-term hearing preservation and controlling tumor ...
Fractionated Proton Radiation Therapy and Hearing ...Our study showed that fractionated proton therapy for vestibular schwannoma was very well-tolerated. One patient reported CN V dysfunction (G1 ...
Effectiveness and Toxicity of Fractionated Proton Beam ...A case series supported the fact that fractionated PRT for vestibular schwannoma is well tolerated and provides good local control (17). A ...
Long-Term Outcomes of Fractionated Stereotactic Proton ...Our results show that standard-fractionated stereotactic PT for VS is well tolerated and offers good local control. Further investigation is ...
Outcome after Radiotherapy for Vestibular Schwannomas ...A recent review investigating the outcome of large VS after RT showed that tumor control was achieved in 89%, 94% and 91% of patients respectively. NF2 patients ...
Chapter 28 - Proton therapy for vestibular schwannomasThis chapter discusses the treatment of vestibular schwannoma using proton beam therapy (PBT), which has been used in stereotactic radiosurgery, ...
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