Clinical trial NCT06549478: Biology-Guided Radiation Therapy for the Treatment of Patients with Bone Metastases
Official title: A Pilot Study of BgRT for Bone Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Metastatic Malignant Neoplasm in the Bone
Metastatic Malignant Solid Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-08-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 1 year follow-up
measure: Pain response
timeFrame: Up to 1 year follow-up
Secondary outcomes:
measure: Rates of re-irradiation
timeFrame: At 1 year follow-up
measure: Radiographic evidence of disease progression
timeFrame: Up to 1 year follow-up
measure: Patient-reported health related quality of life (QOL)
timeFrame: Up to 1 year follow-up
measure: Incidence of clinician-related chronic toxic effects
timeFrame: Up to 1 year follow-up
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Yi-Jen Chen
role: PRINCIPAL_INVESTIGATOR
References: