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NCT Number: NCT05534321

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 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.

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Key information

Conditions

Spine Metastases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Miami Cancer Institute at Baptist Health South Florida

Miami, Florida, 33176, United States

Location status: Recruiting

Location contact

Rupesh Kotecha, MD

CONTACT

[email protected]

786-596-2000

Rupesh Kotecha, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically-confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on cross-sectional imaging.
  • Has high-risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risk metastases are defined as:
  • Bulkiest sites of spinal osseous disease ≥ 2cm,
  • Disease at junctional levels, including the thoracic apex (Occiput to C2, C7-T1, T12-L2, and L5- S1)
  • Disease with posterior element involvement, including interspinous, unilateral, or bilateral facet joints.
  • Vertebral body compression deformity > 50%.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
  • Age ≥ 18 years.
  • Able to provide informed consent.
  • Patients at reproductive potential must agree to practice an effective contraceptive method. Women of childbearing potential must not be pregnant or lactating.

Exclusion criteria

  • Previous RT to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
  • Serious medical co-morbidities precluding RT.
  • Pregnant or lactating women.
  • Target lesion(s) is/are complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture.
  • Leptomeningeal disease.
  • Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.

Treatment and study plan

Prophylactic Radiotherapy

Radiation

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

Drug

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 outcomes

  1. Number of patients who have skeletal-related events (SREs)

    Time frame: 1 year

    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)

Secondary outcomes

  1. Number of skeletal-related event (SRE) hospitalizations

    Time frame: 1 year

    Number of hospitalizations attributed to skeletal-related events (SREs)

  2. Pain-related quality of life

    Time frame: 3 months, 6 months, and 12 months, optionally within 1 week of a skeletal-related event (SRE)

    Pain-related quality of life using the Brief Pain Inventory (BPI) form. The BPI is a 17-item patient self-rating scale assessing demographic data, use of medications, as well as the sensory and reactive components of pain. The scale is from 0-10, and there are breakpoints between scores of 4 and 5 and between 6 and 7, indicating that mild pain correlates with scores of 1-4, moderate pain with 5-6, and severe pain with scores of 7-10.

  3. Health care utilities and quality of life

    Time frame: 3 months, 6 months, and 12 months, optionally within 1 week of a skeletal-related event (SRE)

    Health care utilities and quality of life using the EuroQol Group EQ-5D-5L form and FACT-G questionnaires. It has been developed to generate a generic cardinal index of health, thus giving it considerable potential for future use in economic evaluation. The EQ-5D-5L is a two-part, patient-completed questionnaire. The first part consists of 5 items covering 5 dimensions including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on 3 levels including: 1=no problems; 2= moderate problems; and 3=extreme problems. The second component is the visual analog scale, where the participant rates their own overall health on a scale of 0 (worst health) to 100 (best health).

  4. Pain-free survival (PFS)

    Time frame: Until 1 year

    Pain-free survival (PFS) is defined as the time from study entry to until the start of opioid use or until death.

  5. Overall survival (OS)

    Time frame: Until 1 year

    Overall survival (OS) is defined as the time from study entry until death.

  6. Adverse event frequency and severity

    Time frame: 3 months, 6 months, and 12 months

    Evaluate CTCAE v5 toxicity events in the upfront RT arm by tabulating all toxicities and summarizing the CTCAE v5 scores.

Study contacts

Contact information is provided by the study sponsor or research team.

Pimental

CONTACT

17865962000

Rupesh R Kotecha, MD

CONTACT

[email protected]

17865962000

Sponsors and collaborators

Lead sponsor

Baptist Health South Florida

Other

Registry information

Official study title

Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease (PROMISSeD Trial)

Acronym: PROMISSeD

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Sep 9, 2022
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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