Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease

NCT05534321 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 74 participants
Start Date 2022-08-29
Est. Completion 2027-09
Phase Phase 1

Sponsor

Baptist Health South Florida

82 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05534321

The ClinicalTrials.gov registry entry for NCT05534321 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baptist Health South Florida, which has 82 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05534321 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05534321?

The interventions under investigation include: Prophylactic Radiotherapy (RADIATION), Standard of care systemic therapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05534321?

This trial is sponsored by Baptist Health South Florida, which has 82 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial