Proton beam may spare healthy brain tissue in young tumor patients
NCT ID NCT01049230
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether proton beam radiation can effectively treat germ cell tumors in the brain while causing fewer side effects than standard photon radiation. About 45 participants aged 3 to 25 will receive daily proton radiation for 4 to 8 weeks. Researchers will track side effects and how long the tumor stays under control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Proton beam radiation
- What this could lead to
- If successful, this could show that proton radiation is a safer way to treat brain germ cell tumors with fewer long-term side effects than standard radiation.
- What could go wrong
- This is a small, early-phase study with only 45 participants, so results may not apply to everyone. The treatment still carries risks of radiation side effects, and it is not a cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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45 people
The number who actually took part.
- Start date
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Jun 2010
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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3 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed germ cell tumor or elevated AFP or B-HCG in the setting of radiographic disease consistent with a germ cell tumor. Disease must be confined to the central nervous system. * Participants do not need to have measurable disease. Most patients will not have measurable disease at the time of treatment. * 3 years of age or older and 25 years of age or younger at the time of diagnosis because this study evaluates this disease entity in the pediatric population which may differ from the adult population. * Life expectancy of greater than 12 months. * ECOG performance status of 0, 1 or 2 * Baseline MRI of the brain and spinal axis with gadolinium and prior to any chemotherapy is required. If surgical resection is performed a post-operative MRI is required. If the patient receives chemotherapy prior to radiation, a post-chemotherapy MRI of the brain is required. If spinal involvement was seen on initial MRI and prior to chemotherapy, a MRI of the spine is required after chemotherapy and prior to radiation. * Serum and lumbar CSF must be obtained to evaluate for alpha fetoprotein (AFP) and beta human chorionic gonadotropin (HCG). This is needed to stratify patients into pure GCT and NGGCT. * Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Exclusion Criteria: * Patients will be ineligible if any prior therapeutic radiation therapy \> 200 cGy has been delivered to the central nervous system. * Patients will be ineligible if chemotherapy was completed greater than 1 year from the planned start date of radiation therapy or if the patient is referred for radiation therapy after a relapse following a regimen with chemotherapy alone. * Individuals with a history of a different malignancy are ineligible except for the following circumstances: Disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals diagnosed and treated within the past 5 years for cervical cancer in situ and basal cell or squamous cell carcinoma of the skin. * Pregnant females
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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