This phase III trial compares the effect of single to multi-fraction stereotactic radiosurgery for the treatment of patients with solid tumor that has spread to spine (metastases). Spinal metastases are cancer cells that travel to the spine from another area of the body. When these cells grow uncontrollably, a tumor develops. Spine metastases have traditionally been managed with surgery and conventional radiation therapy with intent of relieving symptoms. However, radiation using conventional approaches is associated with low rates of complete response to pain and local control. Information gathered from this study may help researchers learn how stereotactic radiosurgery may be effective for treating patients with spine metastases.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06173401.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo AltoStatus: Active
Contact: Erqi Pollom
Phone: 650-498-0484
PRIMARY OBJECTIVE:
I. To determine whether fractionated stereotactic radiosurgery (SRS) for spine metastases is associated with improved local tumor control at 1 year following SRS compared to single-fraction SRS.
SECONDARY OBJECTIVES:
I. To compare health-related quality of life (HRQOL) following SRS (EuroQol-5 Dimension [EQ-5D], European Organization for Research and Treatment of Cancer QOL-C30 [EORTC QLQ-C30] and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients with Bone Metastases [EORTC QLQ-BM22]).
II. To describe pain associated with treated area at baseline, 1-2 weeks after SRS, and at 1, 3, 6, 12 months following SRS.
III. To determine 1-year rate Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher adverse effects, following SRS.
IV. To determine 1-year rate of vertebral compression fracture (VCF), following SRS.
V. To determine 2-year rate of local failure following SRS.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo spine SRS in 1 treatment fraction for 1 day in the absence of disease progression or unacceptable toxicity. Patients also undergo positron emission tomography (PET) and/or magnetic resonance imaging (MRI) and/or computed tomography (CT) during screening.
ARM II: Patients undergo spine SRS in 2 treatment fractions for 2 days in the absence of disease progression or unacceptable toxicity. Patients also undergo PET and/or MRI and/or CT during screening.
After completion of study treatment, patients are followed up at 1-2 weeks, 1 month, 3, 6, 12, 18 and 24 months.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorErqi Pollom
