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Phase II Study of Individualized Stereotactic Body Radiotherapy of Liver Metastases

Phase 2
18 Years
Open (Enrolling)
Solid Tumor, Liver Metastases

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Trial Information

Phase II Study of Individualized Stereotactic Body Radiotherapy of Liver Metastases

- Participants receiving SBRT with protons, will receive radiation treatment as an
outpatient at the Francis H. Burr Proton Therapy Center at Massachusetts General
Hospital. Participants receiving SBRT with photons, will receive radiation treatment
as an outpatient at Brigham and Women's 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

- 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.

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

- 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

- Only solid tumors are permitted. Thus, individuals with a liver mass from a
diagnosis of lymphoma or leukemia are excluded

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local Control Rate

Outcome Description:

To demonstrate a 1 year local control rate of greater than 70%

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Theodore S. Hong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

June 2010

Completion Date:

Related Keywords:

  • Solid Tumor
  • Liver Metastases
  • photon radiation
  • proton radiation
  • stereotactic body radiotherapy
  • SBRT
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms



Massachusetts General HospitalBoston, Massachusetts  02114-2617
Dana-Farber Cancer InstitueBoston, Massachusetts  02115