Proton Beam Radiation Therapy for Brain Tumor

Not currently recruiting at 1 trial location
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether proton beam radiation can effectively treat germ cell tumors in the brain and spinal area. Proton beam therapy, a type of radiation, targets tumors more precisely, potentially reducing damage to surrounding healthy tissue and leading to fewer side effects compared to traditional photon radiation. The trial seeks participants aged 3 to 25 with a confirmed germ cell tumor in the central nervous system who have not undergone certain types of radiation therapy. As an unphased trial, this study offers a unique opportunity to advance treatment options for germ cell tumors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that proton beam radiation therapy is safe for brain tumor treatment?

Research has shown that proton beam radiation therapy can be safer for healthy brain tissue compared to traditional radiation methods. Studies indicate that this treatment controls tumors just as effectively but with less risk to healthy areas. For example, one study found a low risk of serious harm to the brainstem (the lower part of the brain) in patients who received proton beam therapy, suggesting it is well-tolerated.

Another study highlighted that proton therapy focuses directly on the tumor, resulting in less radiation affecting the surrounding healthy tissues. This can lead to fewer side effects compared to other radiation treatments. While all treatments can have side effects, proton beam therapy has demonstrated promising results in protecting healthy tissue.12345

Why are researchers excited about this trial?

Proton beam radiation therapy is unique because it uses positively charged particles, called protons, to precisely target brain tumors. Unlike traditional radiation therapies that use X-rays, protons can be controlled to release their energy directly at the tumor site, minimizing damage to surrounding healthy tissues. Researchers are excited about this treatment because it has the potential to reduce side effects and improve outcomes by focusing the radiation dose more accurately, making it a promising option for treating brain tumors.

What evidence suggests that proton beam radiation is effective for brain tumors?

Research has shown that proton beam therapy, which participants in this trial will receive, effectively treats brain tumors. Studies have found that it controls tumors in the brain and spine while reducing side effects like tiredness. It also protects healthy tissue better than traditional radiation, allowing higher doses to safely target the tumor. This can lead to better survival rates and quality of life for patients. Overall, proton beam therapy shows promise in managing brain tumors with fewer negative effects on the body.678910

Who Is on the Research Team?

SM

Shannon MacDonald, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for young people aged 3 to 25 with a confirmed diagnosis of germ cell tumors in the central nervous system. They should have a life expectancy over 12 months, be able to perform daily activities (ECOG status 0-2), and not necessarily have measurable disease. Participants must agree to use contraception.

Inclusion Criteria

Life expectancy of greater than 12 months
I can care for myself and am up and about more than 50% of my waking hours.
Serum and lumbar CSF must be obtained to evaluate for AFP and HCG
See 5 more

Exclusion Criteria

Pregnant females
I have received radiation therapy to my brain or spinal cord.
I have had another type of cancer, but it meets certain conditions.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparation

Scans are done to prepare participants for radiation treatment and plan the best way to deliver radiation to the tumor

1 week

Radiation Treatment

Participants receive proton beam radiation therapy once a day, 5 days a week, for 4-8 weeks

4-8 weeks
5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Proton Beam radiation
Trial Overview The study tests proton beam radiation therapy's effectiveness on CNS germ cell tumors, aiming to kill tumor cells while sparing normal tissue. It compares this method's outcomes and side effects against those from traditional photon radiation therapy.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Proton beam radiationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Dana-Farber Cancer Institute

Collaborator

Trials
1,128
Recruited
382,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Citations

A review of proton beam therapy's role in glioma managementPBT significantly reduces neurocognitive decline and enhances quality of life while achieving comparable or superior survival outcomes across various glioma ...
Proton Beam Therapy Can Target Brain and Spine Tumors ...“The trial showed that proton craniospinal irradiation resulted in improved control of the cancer in the brain and spine, and better overall ...
Proton Therapy for Brain & Spine CancerCompared to those assigned to x-rays, patients treated with proton therapy had a statistically lower rate of fatigue (24% vs. 58%) and on average had fewer ...
Therapeutic Outcomes and Toxicity Mitigation of Proton ...Across the 10 studies that met inclusion criteria, proton therapy consistently demonstrated effectiveness in tumor control while significantly ...
Proton therapy for brain tumours in the area of evidence ...This review details the indication of brain tumors for proton therapy and give a list of the open prospective trials for these challenging tumors.
Therapeutic Outcomes and Toxicity Mitigation of Proton Beam ...PBT demonstrated equivalent tumor control and survival outcomes compared to conventional therapies while offering significantly reduced risks of ...
Brainstem Toxicity Following Proton Beam Radiation Therapy ...This study revealed a low incidence of symptomatic brainstem toxicity and related mortality among pediatric brain tumor patients undergoing proton beam ...
Proton or photon? Comparison of survival and toxicity of two ...Our aim was to determine which of the two major irradiation options, proton (PT) or photon (XRT), was the least harmful yet effective for children with brain ...
Side effects of Proton Beam Therapy (PBT)It does less damage to the healthy tissue around the tumour and the rest of the brain. This means it causes fewer side-effects, however, there are a few side- ...
Tracking Outcomes in Proton Therapy for CancerA proton beam delivers a targeted dose of radiation directly to the tumor or desired target—but very little radiation to surrounding tissues.
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