Precision proton beam aims to zap liver tumors with fewer side effects
NCT ID NCT00976898
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested proton beam radiation, a highly targeted form of radiotherapy, in 83 people with liver cancer that could not be surgically removed. The goal was to see if this precise approach could control tumors while reducing damage to healthy tissue. Participants received daily treatments for three weeks, and researchers tracked tumor control and survival over two years.
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 offer a more precise and safer radiation option for people with liver cancer that cannot be removed by surgery.
- What could go wrong
- This is a small, early-phase study with no comparison group. Results may not apply to all liver cancer patients, and some may still experience side effects or tumor regrowth.
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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83 people
The number who actually took part.
- Start date
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Aug 2009
- Finished
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Jul 2018
- 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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18 years and older
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Biopsy proven unresectable or locally recurrent hepatocellular cancer or intrahepatic cholangiocarcinoma. Patients with a single lesion must be 12cm or less in greatest dimension. For patients with two lesions, no lesion may be greater than 10cm in greatest dimension. For patients with three lesions, no lesion may be greater than 6cm in greatest dimension. Patients may have single or multinodular tumors (up to 3). There must be no evidence of extrahepatic tumor. Portal vein involvement or thrombosis is allowed. * Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as 20mm or greater with conventional techniques or as 10mm or greater with spiral CT scan. * Patients may have had prior chemotherapy, targeted biological therapy, surgery, transarterial chemoembolization (TACE), radiofrequency ablation, or cryosurgery for their disease as long as it is greater than 4 weeks from first protocol radiation treatment (6 weeks for nitrosoureas or mitomycin C). Patients may not have had prior radiation to the affected area. * 18 years of age or older * Expected survival must be greater than three months * ECOG Performance Status of 0, 1 or 2 * Normal organ and marrow function as outlined in the protocol * If patient has underlying cirrhosis, only Child-Pugh classification Group A or Group B patients should be included in this study. * Patients must be either surgically sterile or post-menopausal. Male and female patients of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of the study participation. * Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin Exclusion Criteria: * Women who are pregnant or lactating * Patients with evidence of non-hepatic metastatic disease * Local conditions or systemic illnesses which would reduce the local tolerance to radiation treatment, such as serious local injuries, active collagen vascular disease, etc. * Prior liver directed radiation treatment * Patients may have no serious medical illness, which may limit survival to less than 3 months * Patients may have no serious psychiatric illness/social situations which would limit compliance with study requirements * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Patients may not be receiving any other study agents * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
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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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University of Pennsylvania, Roberts Proton Facility
Philadelphia, Pennsylvania, United States
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University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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