Comparing two types of 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 phase III randomized controlled trial aims to compare Stereotactic Body Radiation Therapy (SBRT) with conventional palliative radiation therapy (CRT) in patients suffering from painful non-spine bone metastases. The study will enroll 230 participants who will receive either SBRT or CRT over five treatment sessions. Participants will be monitored for pain relief and radiological progression at 3 and 6 months post-treatment. The goal is to determine which treatment provides better pain management while minimizing damage to surrounding healthy tissues.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologic confirmation of solid tumour.
* Patient with a dominant painful non-spine bone metastasis and a worst minimum pain score of 2 using the BPI attributed to that dominant site
* Expected overall survival of greater than 6 months as determined by the treating physician
* Suitable for protocol defined SBRT and CRT.
* Stable pain with no immediate plan to alter analgesic regimen.
* ECOG performance status of 0-2.
* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrolment in the trial to document their willingness to participate

Exclusion Criteria:

* Metastases of the hands, feet, cranium or spine (including sacrum) as the dominant/index pain site.
* Bone metastasis arising from a small cell or germ cell.
* Radionuclide therapy within 30 days of randomization.
* Patient treated with prior palliative RT to the dominant painful bone metastasis site (prior radiation exposure is permitted if prior to development of the dominant metastasis and would not influence the applicability of either treatment arm of the current study).
* Received systemic chemotherapy within 1 week of the protocol RT, or who are expected/planned to receive chemotherapy within one week of completing protocol RT.
* Participants with an unstable pathologic fracture at the dominant painful bone metastasis, or for whom surgical fixation would be the preferred intervention if possible.
* Pregnant or lactating individuals.

Where it's running

• Arthur J.E. Child Comprehensive Cancer Centre
  Calgary, Alberta, Canada Recruiting
• BCCA - Vancouver
  Vancouver, British Columbia, Canada Recruiting
• Juravinski Cancer Centre at Hamilton Health Sciences
  Hamilton, Ontario, Canada Recruiting
• Kingston Health Sciences Centre
  Kingston, Ontario, Canada Recruiting
• London Health Sciences Centre Research Inc.
  London, Ontario, Canada Recruiting
• Stronach Regional Health Centre at Southlake
  Newmarket, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Wendy Parulekar
• Email: wparulekar@ctg.queensu.ca
• Phone: 613-533-6430

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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.