NCT05534321 Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease
| NCT ID | NCT05534321 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Baptist Health South Florida |
| Condition | Spine Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2022-08-29 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 74 participants in total. It began in 2022-08-29 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Histologically-confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on cross-sectional imaging. 2. Has high-risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risk metastases are defined as: 1. Bulkiest sites of spinal osseous disease ≥ 2cm, 2. Disease at junctional levels, including the thoracic apex (Occiput to C2, C7-T1, T12-L2, and L5- S1) 3. Disease with posterior element involvement, including interspinous, unilateral, or bilateral facet joints. 4. Vertebral body compression deformity \> 50%. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2. 4. Age ≥ 18 years. 5. Able to provide informed consent. 6. Patients at reproductive potential must agree to practice an effective contraceptive method. Women of childbearing potential must not be pregnant or lactating. Exclusion Criteria: 1. Previous RT to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances. 2. Serious medical co-morbidities precluding RT. 3. Pregnant or lactating women. 4. Target lesion(s) is/are complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture. 5. Leptomeningeal disease. 6. Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.
Contact & Investigator
Rupesh R Kotecha, MD
PRINCIPAL INVESTIGATOR
Miami Cancer Institute
Frequently Asked Questions
Who can join the NCT05534321 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spine Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05534321 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05534321 currently recruiting?
Yes, NCT05534321 is actively recruiting participants. Contact the research team at rupeshk@baptisthealth.net for enrollment information.
Where is the NCT05534321 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT05534321 clinical trial?
NCT05534321 is sponsored by Baptist Health South Florida. The principal investigator is Rupesh R Kotecha, MD at Miami Cancer Institute. The trial plans to enroll 74 participants.