Recruiting
Phase 1
Phase 2

Radiotherapy

Sponsor:

Baptist Health South Florida

Code:

NCT05534321

Conditions

Spine Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prophylactic Radiotherapy

Standard of care systemic therapy

Study Details

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.

Conditions

Spine Metastases

Study ID

NCT05534321

Start date

Aug 29, 2022

Status verified date

Oct, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Standard of Care Systemic Therapy or Surveillance

Patients randomized to arm 1 will undergo appropriate systemic therapy as determined by their oncology team. These patients will either continue the current therapy or be transitioned to a new standard of care therapy at the discretion of the treating oncologist. If randomized to arm 1, these patients may also undergo palliative radiation therapy for progressive or painful lesions (a skeletal related event as defined in the study) at the time of symptom development\*(not upfront palliative radiation therapy)

experimental: Prophylactic Radiation Therapy

Patients randomized to Arm 2 of the study will undergo upfront prophylactic radiotherapy to ≤ 5 highest risk bone metastases followed by standard of care, as defined by:

1. Bulkiest sites of disease ≥ 2cm (can include paraspinal disease extension)
2. Disease in junctional spine (Occ-C2, C7-T1, T12-L1, L5-S1)
3. Disease with posterior element involvement (facet(s), interspinous)
4. Compression Deformity > 50%

Interventions

Prophylactic Radiotherapy

Radiation therapy will be delivered according to department standards. For this protocol, total dose and dose fractionation may be delivered at the discretion of the treating radiation oncologist according to department standards. All techniques including conventional, three-dimensional conformal radiation therapy (3D-CRT), intensity-modulated radiation therapy (IMRT), and stereotactic radiosurgery/stereotactic body radiation therapy (SRS/SBRT) techniques may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards.

Standard of care systemic therapy

Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating medical oncologist. Patients may receive systemic therapy concurrently and there are no restrictions on initiation of systemic agents after radiotherapy including immunotherapy and hormonal therapy, the timing of which will be determined by a consensus between the treating medical and radiation oncologists.

Primary outcome measure

  • Number of patients who have skeletal-related events (SREs) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Rupesh R Kotecha, MD

(786) 596-2000rupeshk@baptisthealth.net

Kristy Reyes

(786) 596-2000Kristina.Reyes@baptisthealth.net

Locations

Baptist Health Herbert Wertheim Cancer Institute

Recruiting

Miami, Florida, United States, 33176

Contacts

Rupesh Kotecha, MD

786-596-2000RupeshK@baptisthealth.net

Principal Investigator:

Rupesh Kotecha, MD

More Information

Sponsor

Baptist Health South Florida

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • Radiotherapy (RT)
  • Palliative radiotherapy
  • High-risk asymptomatic spine metastases
  • Minimal asymptomatic spine metastases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Baptist Health South Florida on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.