A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases

The goal of SBRT is to deliver appropriate metastasis directed radiotherapy while minimizing
exposure of surrounding normal tissues. The dose used to treat a given metastasis will be based on the location of the metastasis, as normal tissue toxicity is likely to arise from the organs at risk surrounding the metastasis. The starting dose level for each metastatic location has been
selected based on available evidence and expert consensus. Patients who are being considered
for this protocol will be evaluated by a multi-disciplinary committee (see sections 3.1.6 and 3.1.7).
This will ensure any baseline evaluations are performed that are deemed needed for the
particular patient.
Metastatic lesions with the following distribution are eligible to be treated with SBRT on this
 3-4 radiographically distinct metastases of any distribution in the allowed
anatomical sites OR
 2 radiographically distinct metastases that must be anatomically close (i.e., with
less than or equal to 5cm of normal tissue between them) OR
 3 or 4 distinct metastases, 2 or 3 to be treated with SBRT and the other (s)
having been surgically removed.
All metastases must be located in the metastatic locations listed in Section 6.4.1. See Section 3.0 for more details on eligibility.
SBRT must begin within 4 weeks of study registration. SBRT for all metastases should be
completed within 3 weeks of the first dose of SBRT. It is recommended that metastases are
treated on an every other day schedule. Not all metastases need to receive radiation therapy on the same day.
Phase I
Multiple Tumor Types
Benjamin Bridges , M.D.
NSABP (National Surgical Adjuvant Breast and Bowel Project)
Melissa Pomeroy

The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.