Clinical Trial

Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease

Study acronym: PROMISSeD
Recruiting Phase 1/2
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2022-09-06; most recent amendment 2026-02-13.
Trial Details
NCT Number NCT05534321
Lead Sponsor Baptist Health South Florida
Conditions Spine Metastases
Enrollment 74 participants
Start Date 2022-08-29
Primary Completion 2026-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-02-17