Prophylactic Radiotherapy for Spine Metastases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Miami Cancer Institute at Baptist Health South Florida, Miami, FL
Spine Metastases+2 More
Prophylactic Radiotherapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions

  • Spine Metastases

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Spine Metastases

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 1 year

1 year
Number of patients who have skeletal-related events (SREs)
Number of skeletal-related event (SRE) hospitalizations
Month 12
Adverse event frequency and severity
Month 12
Health care utilities and quality of life
Pain-related quality of life
Until 1 year
Overall survival (OS)
Pain-free survival (PFS)

Trial Safety

Safety Progress

1 of 3

Other trials for Spine Metastases

Trial Design

2 Treatment Groups

Standard of Care Systemic Therapy or Surveillance
1 of 2
Prophylactic Radiation Therapy
1 of 2
Active Control
Experimental Treatment

74 Total Participants · 2 Treatment Groups

Primary Treatment: Prophylactic Radiotherapy · No Placebo Group · Phase 1 & 2

Prophylactic Radiation Therapy
Radiation
Experimental Group · 1 Intervention: Prophylactic Radiotherapy · Intervention Types: Radiation
Standard of Care Systemic Therapy or Surveillance
Drug
ActiveComparator Group · 1 Intervention: Standard of care systemic therapy · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Closest Location: Miami Cancer Institute at Baptist Health South Florida · Miami, FL
Photo of Miami 1Photo of Miami 2Photo of Miami 3
2022First Recorded Clinical Trial
2 TrialsResearching Spine Metastases
1 CompletedClinical Trials

Who is running the clinical trial?

Baptist Health South FloridaLead Sponsor
37 Previous Clinical Trials
7,247 Total Patients Enrolled
2 Trials studying Spine Metastases
140 Patients Enrolled for Spine Metastases
Rupesh R Kotecha, MDPrincipal InvestigatorMiami Cancer Institute
2 Previous Clinical Trials
220 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a performance status of 0 - 2.
Bulkiest sites of spinal osseous disease ≥ 2 cm.
You have disease with posterior element involvement, including interspinous, unilateral, or bilateral facet joints.
The vertebral body compression deformity is greater than 50%.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References