Proton beam zaps liver tumors: new hope for cancer patients?
NCT ID NCT01239381
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a precise type of radiation called proton beam therapy for people whose cancer has spread to the liver. 92 adults with 1 to 4 liver tumors received this treatment. The goal was to see if it could stop tumor growth and cause fewer side effects than standard radiation.
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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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92 people
The number who actually took part.
- Started
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Oct 2010
- Finished
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Sep 2017
- 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.
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: * Biopsy-proven cancer diagnosis of a solid tumor with 1-4 liver metastases. There is no upper size limit. Liver metastases may be diagnosed by imaging alone, no liver biopsy is required. Extrahepatic disease is allowed if it have been stable for 3 months prior to study entry, the dominant disease burden is intrahepatic and the patient is referred for definitive radiation therapy to the disease in the liver * Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension 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 the prior therapy occured greater than 3 weeks elapsed before the first radiation treatment. Patients may not have had prior liver directed radiation, including radioembolization. * 18 years of age or older * Expected survival must be greater than three months * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Patients must have at least 800mL of uninvolved liver * Normal organ and marrow function as outlined in the protocol * If patient has underlying cirrhosis, only Child-Pugh classification Group A patients should be included in this study. Clinical assessment of ascites and encephalopathy is required. Child-Pugh classification must be determined for all study participants at the time of eligibility analysis. * 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: * Women who are pregnant or lactating * Patients with gross ascites or encephalopathy * 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, including selective internal radiation * No serious medical illness, which may limit survival to less than 3 months * No serious psychiatric illness which would limit compliance with treatment * Participants who have had chemotherapy or radiotherapy within 3 weeks prior to starting study treatment or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier * Participants may not be receiving any other investigational agents, or any other anti-cancer therapy during treatment * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia. * Only solid tumors are permitted. Thus, individuals with a liver mass from a diagnosis of lymphoma or leukemia are excluded
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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 Institue
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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