Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease

NCT05534321 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2021-KOT-002
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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)

  1 year

Secondary Outcomes (6)

• Number of skeletal-related event (SRE) hospitalizations

  1 year

• Pain-related quality of life

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

• Health care utilities and quality of life

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

• Pain-free survival (PFS)

  Until 1 year

• Overall survival (OS)

  Until 1 year

Study Arms (2)

Standard of Care Systemic Therapy or Surveillance

ACTIVE COMPARATOR

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)

Drug: Standard of care systemic therapy

Prophylactic Radiation Therapy

EXPERIMENTAL

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%

Radiation: Prophylactic Radiotherapy

Interventions

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.

Prophylactic Radiation Therapy

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.

Standard of Care Systemic Therapy or Surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baptist Health South Florida: lead

Study Sites (1)

Miami Cancer Institute at Baptist Health South Florida

Miami, Florida, 33176, United States

RECRUITING

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Study Officials

• Rupesh R Kotecha, MD

  Miami Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rupesh R Kotecha, MD

CONTACT

17865962000; rupeshk@baptisthealth.net

Pimental

CONTACT

17865962000

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: August 29, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)