Actively Recruiting
Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease
Led by Baptist Health South Florida · Updated on 2026-02-17
74
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Early palliative care has been shown to improve the quality of life and even survival for patients with metastatic cancer. More and more supportive oncology teams in cancer centers now advocate for early integration of radiation therapy (RT) in a patient's palliative management course. While multiple randomized studies have evaluated the efficacy of different RT regimens in the treatment of symptomatic bone lesions, few studies have examined the impact of early, upfront RT for asymptomatic or minimally symptomatic (non- opioid dependent) spine metastases and its efficacy in preventing skeletal-related events (SREs). Since the pathophysiology of spinal metastatic disease is distinct from other bony metastatic disease, the proposed trial seeks to understand whether it is beneficial to patients with minimally symptomatic disease to undergo upfront RT to reduce the risks of SREs and their sequelae, including hospitalizations.
CONDITIONS
Official Title
Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed solid tumor cancer with more than 5 metastatic sites seen on imaging
- Presence of high-risk spinal bone metastases that are asymptomatic or minimally symptomatic and not requiring opioids
- High-risk metastases include largest sites of spinal bone disease ≥ 2 cm, disease at spine junction levels, involvement of posterior spine elements, or vertebral body compression deformity > 50%
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Age 18 years or older
- Ability to provide informed consent
- Patients able to use effective contraception if of reproductive potential, and women of childbearing potential must not be pregnant or breastfeeding
You will not qualify if you...
- Previous radiation therapy to the planned treatment site that prevents safe treatment planning
- Serious medical conditions that prevent receiving radiation therapy
- Pregnant or breastfeeding women
- Bone metastases complicated by spinal cord compression or risk of pathological fracture
- Presence of leptomeningeal disease
- Patients whose participation would cause unacceptable delays in their planned treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Miami Cancer Institute at Baptist Health South Florida
Miami, Florida, United States, 33176
Actively Recruiting
Research Team
R
Rupesh R Kotecha, MD
CONTACT
P
Pimental
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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