Biology-guided radiation therapy for painful bone metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of a single-dose biology-guided radiation therapy (BgRT) for patients suffering from painful bone metastases due to cancer. The study aims to assess pain response and quality of life improvements following treatment, utilizing advanced imaging techniques to precisely target biologically active tumors. Participants will receive a single fraction of BgRT and will be monitored for pain relief, quality of life, and any adverse effects over a year. The innovative approach of BgRT allows for real-time adjustments during treatment based on live imaging data.

Why it matters

Who can join: the full rules

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)

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting

Study contacts

• Principal investigator: Yi-Jen Chen — City of Hope Medical Center
• Study coordinator: Yi-Jen Chen, MD
• Email: yichen@coh.org
• Phone: 626-218-4589

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.