Individualized Stereotactic Body Radiotherapy of Liver Metastases

NCT01239381 | Completed Results DMC

• 2 other identifiers: 10-139Other
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Solid Tumor; Liver Metastases

Keywords

proton radiation; stereotactic body radiotherapy; SBRT

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (6)

• Median Follow-up Time

  1 year

• Median Overall Survival

  2 years

• Median Progression Free Survival

  1 years

• 2-year Local Control Rate

  2 years

• 1 Year Local Control Rate Among Participants With Colorectal Cancer

  1 year

Study Arms (1)

SBRT-Proton

EXPERIMENTAL

Stereotactic body radiotherapy by proton radiation

Radiation: Stereotactic body radiotherapy-proton

Interventions

Stereotactic body radiotherapy-proton RADIATION

Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks

SBRT-Proton

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Brigham and Women's Hospital: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institue

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 28954285 DERIVED

Results Point of Contact

• Title: Theodore S Hong, MD, physician radiation oncology
• Organization: Massachusetts General Hospital

TSHONG1@mgh.harvard.edu

617-726-6050

Study Officials

• Hannah J. Roberts, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: November 11, 2010
• Study Start: October 5, 2010
• Primary Completion: January 1, 2016
• Study Completion: September 1, 2017
• Last Updated: September 30, 2025
• Results First Posted: July 13, 2017

Record last verified: 2025-09

Locations

US (2)