Early palliative radiation versus observation for high-risk asymptomatic or minimally symptomatic bone metastases: study
- PDF / 821,144 Bytes
- 12 Pages / 595.276 x 790.866 pts Page_size
- 91 Downloads / 133 Views
STUDY PROTOCOL
Open Access
Early palliative radiation versus observation for high-risk asymptomatic or minimally symptomatic bone metastases: study protocol for a randomized controlled trial Daniel B. Rosen1†, Cory D. Benjamin1†, Joanna C. Yang1, Connor Doyle1, Zhigang Zhang2, Chris A. Barker1, Max Vaynrub3, T. Jonathan Yang1* and Erin F. Gillespie1,4*
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. Keywords: Bone metastasis, Radiation therapy, Skeletal-related events (SRE), Patient-centered outcomes
* Correspondence: [email protected]; [email protected] † D. B. Rosen and C. D. Benjamin contributed equally to this work. 1 Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, Box 22, New York, NY 10065, USA Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or
Data Loading...
