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NCT05534321 · ClinicalTrials.gov registry record · Phase 1
Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease
A Phase 1 study of Spine Metastases, sponsored by Baptist Health South Florida.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
- 1
- Study location
NCT05534321: Recruiting Phase 1 study of Spine Metastases, sponsored by Baptist Health South Florida.
NCT05534321 is a Phase 1 study of Spine Metastases that is actively recruiting participants, run by Baptist Health South Florida. The registered enrollment target is 74 participants, below the 482-participant average among 7 other Spine Metastases trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05534321, a Phase 1 study of Spine Metastases, is actively recruiting participants, sponsored by Baptist Health South Florida.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Number of skeletal related events (SREs), which will be defined as pathological fractures, spinal cord compression, or interventions (palliative RT, interventional procedures, or spine surgery)
Conditions Studied
Interventions
- RADIATION Prophylactic Radiotherapy
- DRUG Standard of care systemic therapy
Study Locations (1)
Florida
- Miami Cancer Institute at Baptist Health South Florida - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2022-08-29 |
| Est. Completion | 2027-09 |
| Phase | Phase 1 |
What NCT05534321 shows while recruiting
NCT05534321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 482-participant average among 7 other Spine Metastases trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Spine Metastases appearing as the primary indexed condition, and to 2 interventions - of which Prophylactic Radiotherapy is the first listed.
NCT05534321 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05534321 about?
NCT05534321 is a clinical study titled "Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease". 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 multipl...
What is the current status of trial NCT05534321?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2022-08-29. Estimated completion is 2027-09.
What conditions does trial NCT05534321 study?
This clinical trial studies the following conditions: Spine Metastases.
What interventions are being tested in trial NCT05534321?
The interventions under investigation include: Prophylactic Radiotherapy (RADIATION), Standard of care systemic therapy (DRUG).
Who is sponsoring clinical trial NCT05534321?
This trial is sponsored by Baptist Health South Florida, which has 40 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05534321 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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