Early palliative radiation versus observation for high-risk asymptomatic or minimally symptomatic bone metastases: study protocol for a randomized controlled trial

Daniel B. Rosen, Cory D. Benjamin, Joanna C. Yang, Connor Doyle, Zhigang Zhang, Chris A. Barker, Max Vaynrub, T. Jonathan Yang, Erin F. Gillespie

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

Background: In patients with metastatic cancer, the bone is the third-most common site of involvement. Radiation to painful bone metastases results in high rates of pain control and is an integral part of bone metastases management. Up to one-third of inpatient consults are requested for painful bone metastases, and up to 60% of these patients had evidence of these lesions visible on prior imaging. Meanwhile recent advances have reduced potential side effects of radiation. Therefore, there is an opportunity to further improve outcomes for patients using prophylactic palliative radiation to manage asymptomatic bone metastases. Methods/study design: In this trial, 74 patients with metastatic solid tumors and high-risk asymptomatic or minimally symptomatic bone metastases will be enrolled and randomized to early palliative radiation or standard of care. This will be the first trial to assess the efficacy of prophylactic palliative radiation in preventing skeletal related events (SREs), the primary endpoint. This endpoint was selected to encompass patient-centered outcomes that impact quality of life including pathologic fracture, spinal cord compression, and intervention with surgery or radiation. Secondary endpoints include hospitalizations, Bone Pain Index, pain-free survival, pain-related quality of life, and side effects of radiation therapy. Discussion: In this study, we propose a novel definition of high-risk bone metastases most likely to benefit from preventive radiation and use validated questionnaires to assess pain and impact on quality of life and health resource utilization. Observations from early patient enrollment have demonstrated robustness of the primary endpoint and need for minor modifications to Bone Pain Index and data collection for opioid use and hospitalizations. With increasing indications for radiation in the oligometastatic setting, this trial aims to improve patient-centered outcomes in the polymetastatic setting. Trial registration: ISRCTN Number/Clinical trials.gov, ID:NCT03523351. Registered on 14 May 2018.

Original languageEnglish
Article number1115
JournalBMC Cancer
Volume20
Issue number1
DOIs
StatePublished - Dec 2020

Keywords

  • Bone metastasis
  • Patient-centered outcomes
  • Radiation therapy
  • Skeletal-related events (SRE)

Fingerprint

Dive into the research topics of 'Early palliative radiation versus observation for high-risk asymptomatic or minimally symptomatic bone metastases: study protocol for a randomized controlled trial'. Together they form a unique fingerprint.

Cite this