Biology-Guided Radiation Therapy for the Treatment of Patients with Bone Metastases

City of Hope

Status and phase

Enrolling

Phase 1

Conditions

Metastatic Malignant Neoplasm in the Bone

Metastatic Malignant Solid Neoplasm

Treatments

Other: Questionnaire Administration

Procedure: Computed Tomography

Procedure: Positron Emission Tomography

Radiation: Image Guided Radiation Therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06549478

P30CA033572 (U.S. NIH Grant/Contract)

NCI-2024-06473 (Registry Identifier)

23937

Details and patient eligibility

About

This clinical trial tests the safety and effectiveness of a single-dose treatment of biology-guided radiation therapy (BgRT) in treating patients with painful cancer that has spread from where it first started (primary site) to the bone (bone metastases). Bone metastases can result in significant pain and reduction in quality of life. Single fraction radiation therapy (SFRT) can produce equivalent pain relief compared to multi-fraction radiation therapy, but SFRT treatments generally lead to higher rates of retreatment. BgRT is a new and innovative form of radiation delivery that uses a signal generated by positron emission tomography to guide external beam radiation therapy. It is a technology breakthrough that uses live, continuously updated data throughout the entire treatment session to determine exactly where to deliver radiotherapy to biologically active tumors. Giving BgRT may be safe and effective in treating patients with painful bone metastases.

Full description

PRIMARY OBJECTIVE:

I. To evaluate pain response by 14 gray (Gy) single fraction (SF)-BgRT for patients with painful bone metastases.

SECONDARY OBJECTIVE:

I. To evaluate patient-reported health related quality of life (QOL), clinician-rated toxicity per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0, radiographic evidence of disease progression at treated sites, and rate of re-irradiation.

OUTLINE:

Patients undergo a single fraction of BgRT on day 0. Patients undergo positron emission tomography (PET)/computed tomography (CT) on study and optionally during follow up.

After completion of study treatment, patients are followed up at 2 weeks, 3 months and then every 3 months for up to 1 year.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Documented informed consent of the participant and/or legally authorized representative
- Assent, when appropriate, will be obtained per institutional guidelines
Age: ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Pathologic diagnosis of cancer
Painful bone metastases from any solid cancers (i.e., a score of at least 2 on a 0-10 scale, 0 representing no pain and 10 representing maximum pain)
Concurrent treatment of up to 3 radiation fields is allowed
Standardized uptake value maximum (SUVmax) of the target bone lesions on diagnostic PET > 6
Size of the target bone lesion 1.5-5 cm
Pre-screening assessment confirms that the intervention can be administered without exceeding dose constraint guidelines
Patients with brain metastases can be included but brain metastases must be treated prior to enrollment and follow up magnetic resonance imaging (MRI) 3 months after treatment shows stable findings
Life expectancy ≥ 6 months in the opinion of the treating investigators
Off systemic therapy for at least one week prior and one week after study intervention
Patients able to complete pain assessment and quality of life surveys who do not have cognitive impairment

Exclusion criteria

Patients with prior radiation therapy to the treatment sites
Untreated spinal cord compression
Pathologic fracture at the evaluated site
Serious medical comorbidities precluding radiotherapy
Unable to undergo a PET/CT scan
Pregnant and/or breastfeeding women are excluded from this study as these agents may have the potential for teratogenic or abortifacient effects
Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics, patients who exhibit cognitive impairments/ who are unable to complete study materials: assessments/questionnaires)