Individualized Stereotactic Body Radiotherapy of Liver Metastases
Status: Recruiting
Phase: Phase 2
Diagnosis: Radiation Oncology
NCT ID: NCT01239381
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-139
Stereotactic body radiation therapy (SBRT) is a technique that is used to deliver radiation, whether with protons or photons, to sites in the body. All participants in this study will be treated with SBRT; some will receive proton radiation and some will receive photon radiation. Proton beam radiation uses tiny particles to deliver radiation to tumors. Photon beam radiation uses high-energy x-rays to deliver radiation to tumors. The purpose of this research study is to determine if SBRT will prevent tumor growth and reduce the treatment side effects for liver metastases. We will also be looking to see if there is a difference in the radiation side effects when SBRT is given with protons or photons.
Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital, Massachusetts General Hospital/ North Shore Cancer Center
Overall PI:
Harvey Mamon, MD, PhD,
Brigham and Women's Hospital
Site-responsible Investigators:
Theodore Hong, MD,
Massachusetts General Hospital
Contacts:
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Eligibility Criteria
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
arrhythmia.
- Only solid tumors are permitted. Thus, individuals with a liver mass from a
diagnosis of lymphoma or leukemia are excluded