Solid TumorNCT01239381
Individualized Stereotactic Body Radiotherapy of Liver Metastases
A study testing Stereotactic body radiotherapy-proton in people with Solid Tumor and Liver Metastases, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
Stereotactic body radiation therapy (SBRT) is a technique that is used to deliver radiation, to sites in the body. All participants in this study will be treated with SBRT using proton beam radiation. Proton beam radiation uses tiny particles to deliver radiation to tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Liver Metastases
- What is being tested?
- Stereotactic body radiotherapy-proton
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Oct 2010to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institue
Boston, Massachusetts, 02115
About this study
Official title: Phase II Study of Individualized Stereotactic Body Radiotherapy of Liver Metastases
Stereotactic body radiation therapy (SBRT) is a technique that is used to deliver radiation, to sites in the body. All participants in this study will be treated with SBRT using proton beam radiation. Proton beam radiation uses tiny particles to deliver radiation to tumors. The purpose of this research study is to determine if SBRT with protons will prevent tumor growth and reduce the treatment side effects for liver metastases.
Read the detailed description
- Participants receiving SBRT with protons, will receive radiation treatment as an outpatient at the Francis H. Burr Proton Therapy Center at Massachusetts General Hospital.
- Not everyone who participates in this study will be receiving the same dose of radiation. The dose received will be determined by the size and location of the tumor(s).
- Participants will receive 2-3 SBRT treatments per week for two weeks.
- During radiation therapy visits the following tests/procedures will be performed: vital signs, physical examination, routine blood tests, research blood tests, and radiation planning.
- Follow-up assessments will be performed once at 9 weeks after study treatment, then at 6 months, 12 months, 18 months and 24 months after treatment.
- Conditions
- Solid Tumor, Liver Metastases
- Being tested
- Stereotactic body radiotherapy-proton
- Keywords
- proton radiation, stereotactic body radiotherapy, SBRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiotherapy-protonRadiation
Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks
| Study group | Role | What they receive |
|---|---|---|
| SBRT-Proton | Experimental | Stereotactic body radiotherapy by proton radiation Receives: Radiation: Stereotactic body radiotherapy-proton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control Rate
The percentage of participants with local control at primary tumor site at one year. Local is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). Local control is defined as achieving either Complete response (CR), Partial Response (PR), or Stable Disease (SD).
- (CR): Disappearance of entire lesion, with no additional evidence of disease.
- (PR): At least a 30% decrease in the (sum of) the longest diameter (LD) of the primary lesion, taken as reference the baseline sum LD.
- (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Measured: 1 year
Secondary outcomes (6)
Median Follow-up Time
The median follow-up time among the 39 participants still alive at the time of analysis, measured from the start of treatment until the time of analysis.
Measured: 1 year
Median Overall Survival
The median overall survival (in months) of participants as measured from the start of treatment.
Measured: 2 years
Median Progression Free Survival
The median amount of time participants survived without cancer progression following the start of study treatment. Progression was assessed using RECIST v1.0. Progressive Disease (PD) is defined as at least a 20% increase in the Longest Diameter (LD) of the lesion, taken as the reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Measured: 1 years
2-year Local Control Rate
The percentage of participants with local control 2 years after the start of study treatment.
Measured: 2 years
1 Year Local Control Rate Among Participants With Colorectal Cancer
The percentage of participants with local control at one year among the participants with colorectal cancer as the primary cancer.
Measured: 1 year
Median Survival Among Participants With Colorectal Cancer
The median amount of time participants survived from the start of treatment, among the participants with colorectal cancer.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study start5 Oct 2010
- Primary completion1 Jan 2016
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Hannah Roberts, Massachusetts General Hospital
- Investigators
- Hannah J. Roberts, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239381
- Sponsor's protocol ID
- 10-139
- Other IDs
- Other
- Status last verified
- Sep 2025
- First submitted
- 14 Jun 2010
- Last updated
- 30 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hong TS, Wo JY, Borger DR, Yeap BY, McDonnell EI, Willers H, Blaszkowsky LS, Kwak EL, Allen JN, Clark JW, Tanguturi S, Goyal L, Murphy JE, Wolfgang JA, Drapek LC, Arellano RS, Mamon HJ, Mullen JT, Tanabe KK, Ferrone CR, Ryan DP, Iafrate AJ, DeLaney TF, Zhu AX. Phase II Study of Proton-Based Stereotactic Body Radiation Therapy for Liver Metastases: Importance of Tumor Genotype. J Natl Cancer Inst. 2017 Sep 1;109(9). doi: 10.1093/jnci/djx031.
PubMed 28954285
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Individualized Stereotactic Body Radiotherapy of Liver Metastases
- ClinicalTrials.gov ID
- NCT01239381
- Acronym / sponsor ID
- 10-139
- Conditions
- Solid Tumor, Liver Metastases
- Keywords
- proton radiation, stereotactic body radiotherapy, SBRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital, National Cancer Institute (NCI)
- Study start
- 5 Oct 2010 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Posted 13 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stereotactic body radiation therapy (SBRT) is a technique that is used to deliver radiation, to sites in the body. All participants in this study will be treated with SBRT using proton beam radiation. Proton beam radiation uses tiny particles to deliver radiation to tumors. The purpose of this research study is to determine if SBRT with protons will prevent tumor growth and reduce the treatment side effects for liver metastases.
Detailed description
- Participants receiving SBRT with protons, will receive radiation treatment as an outpatient at the Francis H. Burr Proton Therapy Center at Massachusetts General Hospital.
- Not everyone who participates in this study will be receiving the same dose of radiation. The dose received will be determined by the size and location of the tumor(s).
- Participants will receive 2-3 SBRT treatments per week for two weeks.
- During radiation therapy visits the following tests/procedures will be performed: vital signs, physical examination, routine blood tests, research blood tests, and radiation planning.
- Follow-up assessments will be performed once at 9 weeks after study treatment, then at 6 months, 12 months, 18 months and 24 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT-Proton | Experimental | Radiation: Stereotactic body radiotherapy-protonStereotactic body radiotherapy by proton radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic body radiotherapy-protonDose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks | Radiation | SBRT-Proton |
Primary outcome
Local Control Rate
Time frame: 1 year
The percentage of participants with local control at primary tumor site at one year. Local is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). Local control is defined as achieving either Complete response (CR), Partial Response (PR), or Stable Disease (SD). * (CR): Disappearance of entire lesion, with no additional evidence of disease. * (PR): At least a 30% decrease in the (sum of) the longest diameter (LD) of the primary lesion, taken as reference the baseline sum LD. * (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
6 secondary outcomes
Median Follow-up Time
Time frame: 1 year
Median Overall Survival
Time frame: 2 years
Median Progression Free Survival
Time frame: 1 years
2-year Local Control Rate
Time frame: 2 years
1 Year Local Control Rate Among Participants With Colorectal Cancer
Time frame: 1 year
Median Survival Among Participants With Colorectal Cancer
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28954285Hong TS, Wo JY, Borger DR, Yeap BY, McDonnell EI, Willers H, Blaszkowsky LS, Kwak EL, Allen JN, Clark JW, Tanguturi S, Goyal L, Murphy JE, Wolfgang JA, Drapek LC, Arellano RS, Mamon HJ, Mullen JT, Tanabe KK, Ferrone CR, Ryan DP, Iafrate AJ, DeLaney TF, Zhu AX. Phase II Study of Proton-Based Stereotactic Body Radiation Therapy for Liver Metastases: Importance of Tumor Genotype. J Natl Cancer Inst. 2017 Sep 1;109(9). doi: 10.1093/jnci/djx031.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah J. Roberts, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic body radiotherapy-proton in people with Solid Tumor and Liver Metastases, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Control Rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01239381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.