Proton Beam Radiation for Brain Tumor
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
Must not be taking: Chemotherapy
Disqualifiers: Prior radiation, Different malignancy, Pregnancy, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
This research study is studying proton radiation as a possible treatment for brain tumor that requires radiation. The radiation involved in this study is: -Proton Radiation
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does allow the use of Vincristine alongside the treatment.
What data supports the effectiveness of the treatment Proton Beam Therapy for brain tumors?
Proton Beam Therapy is promising for brain tumors as it can minimize damage to surrounding healthy tissues and reduce the risk of secondary cancers, especially in pediatric cases. It is considered superior to traditional radiation in certain brain and skull-base tumors, with studies showing it helps maintain cognitive function and quality of life.12345
Is proton beam therapy safe for humans?
Proton beam therapy (PBT) has been used in over 60,000 patients worldwide and is considered safe for treating various conditions, including brain tumors and prostate cancer. Studies have shown that PBT can help reduce side effects compared to traditional radiation therapy by sparing surrounding healthy tissues, although some side effects may still occur.25678
How is proton beam therapy different from other treatments for brain tumors?
Proton beam therapy is unique because it uses positively charged particles (protons) that allow for precise targeting of tumors, minimizing damage to surrounding healthy tissues. This makes it especially beneficial for treating brain tumors located near sensitive areas, reducing the risk of side effects like neurocognitive decline and secondary cancers compared to traditional radiation therapy.1291011
Eligibility Criteria
This trial is for children and teenagers aged 3 to 18 with certain types of brain tumors that need radiation treatment. They should have a life expectancy of at least one year, adequate blood counts, and no prior high-dose radiation therapy. Pregnant teens or those who could become pregnant must not be sexually active or must test negative for pregnancy.Inclusion Criteria
I have a cancer diagnosis that requires radiation to the brain and spine.
Signed informed consent document and assent when appropriate
Your hemoglobin level is higher than 10 grams per liter and your platelet count is greater than 80,000 per microliter.
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Exclusion Criteria
Any major uncontrolled or poorly controlled intercurrent illness that would limit compliance with study requirements
I have received radiation therapy of more than 500 cGy.
I am receiving chemotherapy, but not Vincristine.
See 2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation
Participants receive proton beam radiation therapy once daily, 5 days per week, with a focus on sparing the bony spine
6-8 weeks
Daily visits (in-person) for radiation treatment
Follow-up
Participants are monitored for safety, effectiveness, and changes in growth and development after radiation treatment
5 years
Annual visits (in-person) for evaluations and imaging
Treatment Details
Interventions
- Proton Beam (Proton Therapy)
Trial OverviewThe study is testing proton beam radiation as a potential treatment option for pediatric brain tumors. Proton radiation aims to target the tumor while sparing healthy bone tissue, potentially reducing growth issues caused by traditional radiation treatments.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Proton RadiotherapyExperimental Treatment1 Intervention
* Patients will be treated with Proton Beam once daily 5 days per week.
* Doses will be prescribed such that maximum possible coverage is achieved
Proton Beam is already approved in European Union, United States, Japan, Canada for the following indications:
🇪🇺 Approved in European Union as Proton Therapy for:
- Brain tumors
- Spinal tumors
- Pediatric cancers
- Eye tumors
- Prostate cancer
- Breast cancer
- Lung cancer
- Liver cancer
🇺🇸 Approved in United States as Proton Beam Therapy for:
- Brain tumors
- Spinal tumors
- Pediatric cancers
- Eye tumors
- Prostate cancer
- Breast cancer
- Lung cancer
- Liver cancer
🇯🇵 Approved in Japan as Proton Therapy for:
- Brain tumors
- Spinal tumors
- Pediatric cancers
- Eye tumors
- Prostate cancer
- Breast cancer
- Lung cancer
- Liver cancer
🇨🇦 Approved in Canada as Proton Therapy for:
- Brain tumors
- Spinal tumors
- Pediatric cancers
- Eye tumors
- Prostate cancer
- Breast cancer
- Lung cancer
- Liver cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
MD Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Proton Radiotherapy for Skull-Base Malignancies: Imaging Considerations of Radiotherapy and Complications. [2023]Proton therapy (PT) is a form of highly conformal external-beam radiotherapy used to mitigate acute and late effects following radiotherapy. Indications for treatment include both benign and malignant skull-base and central nervous system pathologies. Studies have demonstrated that PT shows promising results in minimizing neurocognitive decline and reducing second malignancies with low rates of central nervous system necrosis. Future directions and advances in biologic optimization may provide additional benefits beyond the physical properties of particle dosimetry.
[Is proton beam therapy the future of radiotherapy? Part I: clinical aspects]. [2018]Proton beam therapy uses positively charged particles, protons, whose physical properties improve dose-distribution (Bragg peak characterized by a sharp distal and lateral penumbra) compared with conventional photon-based radiation therapy (X-ray). These ballistic advantages apply to the treatment of deep-sited tumours located close to critical structures and requiring high-dose levels. [60-250 MeV] proton-beam therapy is now widely accepted as the "gold standard" in specific indications in adults--ocular melanoma, chordoma and chondrosarcoma of the base of skull --and is regarded as a highly promising treatment modality in the treatment of paediatric malignancies (brain tumours, sarcomas…). This includes the relative sparing of surrounding normal organs from low and mid-doses that can cause deleterious side-effects such as radiation-induced secondary malignancies. Other clinical studies are currently testing proton beam in dose-escalation evaluations, in prostate, lung, hepatocellular cancers, etc. Clinical validation of these new indications appears necessary. To date, over 60,000 patients worldwide have received part or all of their radiation therapy program by proton beams, in approximately 30 treatment facilities.
Individual patient information to select patients for different radiation techniques. [2017]Proton therapy is an emerging technique in radiotherapy which results in less dose to the normal tissues with similar target dose than photon therapy, the current standard. Patient-level simulation models support better decision making on which patients would benefit most.
An evidence based review of proton beam therapy: the report of ASTRO's emerging technology committee. [2018]Proton beam therapy (PBT) is a novel method for treating malignant disease with radiotherapy. The purpose of this work was to evaluate the state of the science of PBT and arrive at a recommendation for the use of PBT. The emerging technology committee of the American Society of Radiation Oncology (ASTRO) routinely evaluates new modalities in radiotherapy and assesses the published evidence to determine recommendations for the society as a whole. In 2007, a Proton Task Force was assembled to evaluate the state of the art of PBT. This report reflects evidence collected up to November 2009. Data was reviewed for PBT in central nervous system tumors, gastrointestinal malignancies, lung, head and neck, prostate, and pediatric tumors. Current data do not provide sufficient evidence to recommend PBT in lung cancer, head and neck cancer, GI malignancies, and pediatric non-CNS malignancies. In hepatocellular carcinoma and prostate cancer and there is evidence for the efficacy of PBT but no suggestion that it is superior to photon based approaches. In pediatric CNS malignancies PBT appears superior to photon approaches but more data is needed. In large ocular melanomas and chordomas, we believe that there is evidence for a benefit of PBT over photon approaches. PBT is an important new technology in radiotherapy. Current evidence provides a limited indication for PBT. More robust prospective clinical trials are needed to determine the appropriate clinical setting for PBT.
Health-related quality of life in patients with primary brain tumors during and three months after treatment with proton beam therapy. [2022]Proton beam therapy (PBT) is increasingly administered to patients with primary brain tumors. Benefits of new treatments must be weighed against side effects and possible deterioration in health-related quality of life (HRQoL). The aim of this study was to describe and compare HRQoL, including acute symptom experiences and associated factors, in patients with malignant and benign brain tumors treated with PBT.
Multi-institutional Phase II study of proton beam therapy for organ-confined prostate cancer focusing on the incidence of late rectal toxicities. [2022]Proton beam therapy (PBT) is theoretically an excellent modality for external beam radiotherapy, providing an ideal dose distribution. However, it is not clear whether PBT for prostate cancer can clinically control toxicities. The purpose of the present study was to estimate prospectively the incidence of late rectal toxicities after PBT for organ-confined prostate cancer.
Early toxicity and patient reported quality-of-life in patients receiving proton therapy for localized prostate cancer: a single institutional review of prospectively recorded outcomes. [2019]We report prospectively captured clinical toxicity and patient reported outcomes in a single institutional cohort of patients treated for prostate cancer with proton beam therapy (PBT). This is the largest reported series of patients treated mostly with pencil beam scanning PBT.
Development and validation of NTCP models for acute side-effects resulting from proton beam therapy of brain tumours. [2019]The limited availability of proton beam therapy (PBT) requires individual treatment selection strategies, such as based on normal tissue complication probability (NTCP). We developed and externally validated NTCP models for common acute side-effects following PBT in brain tumour patients in effort to provide guidance on optimising patient quality of life.
Assessment of Proton Beam Therapy Use Among Patients With Newly Diagnosed Cancer in the US, 2004-2018. [2022]Proton beam therapy (PBT) is a potentially superior technology to photon radiotherapy for tumors with complex anatomy, those surrounded by sensitive tissues, and childhood cancers.
Radiotherapy by particle beams (hadrontherapy) of intracranial tumours: a survey on pathology. [2019]A review of the principal contributions of radio-therapy of brain tumours by beam particles is carried out. Neutrons, protons and light ions are considered along with their pros and cons in relation to types and locations of brain tumours. A particular emphasis is given to the pathologic studies of their effects directly o n tumours and on the normal nervous tissue, considering mainly the relevant action mechanisms of the radiation types and the requirements of the clinical therapeutic strategies. For comparison the main features of the pathologic effects of radiotherapy by photons are described. From the review it emerges that the new modality of radiation by protons and light ions, because of their peculiar physical characteristics, may represent a new way of destroying the tumour and sparing normal nervous tissue, especially when deeply located and irregularly shaped tumours are concerned. More neuropathological studies are needed in order to better understand the potentiality of the new treatment of modalities.
Proton minibeam radiation therapy widens the therapeutic index for high-grade gliomas. [2023]Proton minibeam radiation therapy (pMBRT) is a novel strategy which has already shown a remarkable reduction in neurotoxicity as to compared with standard proton therapy. Here we report on the first evaluation of tumor control effectiveness in glioma bearing rats with highly spatially modulated proton beams. Whole brains (excluding the olfactory bulb) of Fischer 344 rats were irradiated. Four groups of animals were considered: a control group (RG2 tumor bearing rats), a second group of RG2 tumor-bearing rats and a third group of normal rats that received pMBRT (70 Gy peak dose in one fraction) with very heterogeneous dose distributions, and a control group of normal rats. The tumor-bearing and normal animals were followed-up for 6 months and one year, respectively. pMBRT leads to a significant tumor control and tumor eradication in 22% of the cases. No substantial brain damage which confirms the widening of the therapeutic window for high-grade gliomas offered by pMBRT. Additionally, the fact that large areas of the brain can be irradiated with pMBRT without significant side effects, would allow facing the infiltrative nature of gliomas.