Prophylactic Radiotherapy for Spine Metastases
Phase-Based Progress Estimates
Effectiveness
Safety
Miami Cancer Institute at Baptist Health South Florida, Miami, FL
Spine Metastases+2 More
Prophylactic Radiotherapy - RadiationEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
Early palliative care has been shown to improve the quality of life and even survival for patients with metastatic cancer. More and more supportive oncology teams in cancer centers now advocate for early integration of radiation therapy (RT) in a patient's palliative management course. While multiple randomized studies have evaluated the efficacy of different RT regimens in the treatment of symptomatic bone lesions, few studies have examined the impact of early, upfront RT for asymptomatic or minimally symptomatic (non- opioid dependent) spine metastases and its efficacy in preventing skeletal-related events (SREs). Since the pathophysiology of spinal metastatic disease is distinct from other bony metastatic disease, the proposed trial seeks to understand whether it is beneficial to patients with minimally symptomatic disease to undergo upfront RT to reduce the risks of SREs and their sequelae, including hospitalizations.
Eligible Conditions
- Spine Metastases
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: 1 year
1 year
Number of patients who have skeletal-related events (SREs)
Number of skeletal-related event (SRE) hospitalizations
Month 12
Adverse event frequency and severity
Month 12
Health care utilities and quality of life
Pain-related quality of life
Until 1 year
Overall survival (OS)
Pain-free survival (PFS)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Standard of Care Systemic Therapy or Surveillance
1 of 2
Prophylactic Radiation Therapy
1 of 2
Active Control
Experimental Treatment
74 Total Participants · 2 Treatment Groups
Primary Treatment: Prophylactic Radiotherapy · No Placebo Group · Phase 1 & 2
Prophylactic Radiation Therapy
Radiation
Experimental Group · 1 Intervention: Prophylactic Radiotherapy · Intervention Types: RadiationStandard of Care Systemic Therapy or Surveillance
Drug
ActiveComparator Group · 1 Intervention: Standard of care systemic therapy · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Closest Location: Miami Cancer Institute at Baptist Health South Florida · Miami, FL
2022First Recorded Clinical Trial
2 TrialsResearching Spine Metastases
1 CompletedClinical Trials
Who is running the clinical trial?
Baptist Health South FloridaLead Sponsor
37 Previous Clinical Trials
7,247 Total Patients Enrolled
2 Trials studying Spine Metastases
140 Patients Enrolled for Spine Metastases
Rupesh R Kotecha, MDPrincipal InvestigatorMiami Cancer Institute
2 Previous Clinical Trials
220 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have a performance status of 0 - 2.
Bulkiest sites of spinal osseous disease ≥ 2 cm.
You have disease with posterior element involvement, including interspinous, unilateral, or bilateral facet joints.
The vertebral body compression deformity is greater than 50%.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Jensen, Mark P, Judith A Turner, Joan M Romano, and Lloyd D Fisher. 1999. “Comparative Reliability and Validity of Chronic Pain Intensity Measures”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s0304-3959(99)00101-3.
- Mirels, Hilton. 2003. “The Classic: Metastatic Disease in Long Bones A Proposed Scoring System for Diagnosing Impending Pathologic Fractures”. Clinical Orthopaedics and Related Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.blo.0000093045.56370.dd.
- Rosen, Lee S., David Gordon, N. Simon Tchekmedyian, Ronald Yanagihara, Vera Hirsh, Maciej Krzakowski, Marek Pawlicki, et al.. 2004. “Long-term Efficacy and Safety of Zoledronic Acid in the Treatment of Skeletal Metastases in Patients with Nonsmall Cell Lung Carcinoma and Other Solid Tumors”. Cancer. Wiley. doi:10.1002/cncr.20308.
- Lüftner, Diana, Vito Lorusso, Ignacio Duran, Guy Hechmati, Cristina Garzon-Rodriguez, John Ashcroft, Amit Bahl, et al.. 2014. “Health Resource Utilization Associated with Skeletal-related Events in Patients with Advanced Breast Cancer: Results from a Prospective, Multinational Observational Study”. Springerplus. Springer Science and Business Media LLC. doi:10.1186/2193-1801-3-328.
- Cella, D F, D S Tulsky, G Gray, B Sarafian, E Linn, A Bonomi, M Silberman, S B Yellen, P Winicour, and J Brannon. 1993. “The Functional Assessment of Cancer Therapy Scale: Development and Validation of the General Measure.”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.1993.11.3.570.
- Degen, Jeffrey W., Gregory J. Gagnon, Jean-Marc Voyadzis, Donald A. McRae, Michael Lunsden, Sonja Dieterich, Inge Molzahn, and Fraser C. Henderson. 2005. “Cyberknife Stereotactic Radiosurgical Treatment of Spinal Tumors for Pain Control and Quality of Life”. Journal of Neurosurgery: Spine. Journal of Neurosurgery Publishing Group (JNSPG). doi:10.3171/spi.2005.2.5.0540.
- Mundy, Gregory R.. 2002. “Metastasis to Bone: Causes, Consequences and Therapeutic Opportunities”. Nature Reviews Cancer. Springer Science and Business Media LLC. doi:10.1038/nrc867.
- Stopeck, Alison, Michael Rader, David Henry, Mark Danese, Marc Halperin, Ze Cong, Yi Qian, Roger Dansey, and Karen Chung. 2012. “Cost-effectiveness of Denosumab Vs Zoledronic Acid for Prevention of Skeletal-related Events in Patients with Solid Tumors and Bone Metastases in the United States”. Journal of Medical Economics. Informa UK Limited. doi:10.3111/13696998.2012.675380.
- Daut, Randall L., Charles S. Cleeland, and Randall C. Flanery. 1983. “Development of the Wisconsin Brief Pain Questionnaire to Assess Pain in Cancer and Other Diseases”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/0304-3959(83)90143-4.
- Zimmermann, Camilla, Nadia Swami, Monika Krzyzanowska, Breffni Hannon, Natasha Leighl, Amit Oza, Malcolm Moore, et al.. 2014. “Early Palliative Care for Patients with Advanced Cancer: A Cluster-randomised Controlled Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(13)62416-2.
- Badia, Xavier, Michael Herdman, and Paul Kind. 1998. “The Influence of Ill-health Experience on the Valuation of Health”. Pharmacoeconomics. Springer Science and Business Media LLC. doi:10.2165/00019053-199813060-00005.
- Rabin, Rosalind, and Frank de Charro. 2001. “EQ-SD: A Measure of Health Status from the Euroqol Group”. Annals of Medicine. Informa UK Limited. doi:10.3109/07853890109002087.
- Rothrock, R, Bilsky, M, Laufer. Abstract 614, Responder-Analysis of Pain Relief After Surgery for the Treatment of Spinal Metastatic Tumors, Spinal Tumor Surgery 2, November 6, 2021, Paris, FR
- Rades, Dirk, Barbara Šegedin, Antonio J. Conde-Moreno, Raquel Garcia, Ana Perpar, Michaela Metz, Harun Badakhshi, et al.. 2016. “Radiotherapy with 4 Gy × 5 Versus 3 Gy × 10 for Metastatic Epidural Spinal Cord Compression: Final Results of the SCORE-2 Trial (ARO 2009/01)”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2015.64.0862.
- Duran, I., M.G. Fink, A. Bahl, H. Hoefeler, A. Mahmood, D. Lüftner, H. Ghazal, et al.. 2016. “Health Resource Utilisation Associated with Skeletal-related Events in Patients with Bone Metastases Secondary to Solid Tumours: Regional Comparisons in an Observational Study”. European Journal of Cancer Care. Wiley. doi:10.1111/ecc.12452.
- Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.
- Cleeland CS. Measurement of pain by subjective report. In: Chapman CR; Loeser JD, editors. Issues in pain measurement. New York: Raven Press; 1989: 391-403.
- Lutz, Stephen, Tracy Balboni, Joshua Jones, Simon Lo, Joshua Petit, Shayna E. Rich, Rebecca Wong, and Carol Hahn. 2017. “Palliative Radiation Therapy for Bone Metastases: Update of an ASTRO Evidence-based Guideline”. Practical Radiation Oncology. Elsevier BV. doi:10.1016/j.prro.2016.08.001.
- Saad, Fred, and Allan Lipton. 2005. “Zoledronic Acid Is Effective in Preventing and Delaying Skeletal Events in Patients with Bone Metastases Secondary to Genitourinary Cancers”. BJU International. Wiley. doi:10.1111/j.1464-410x.2005.05740.x.
- Lutz, Stephen T., Joshua Jones, and Edward Chow. 2014. “Role of Radiation Therapy in Palliative Care of the Patient with Cancer”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2014.55.1143.
- Saad, F., D. M. Gleason, R. Murray, S. Tchekmedyian, P. Venner, L. Lacombe, J. L. Chin, J. J. Vinholes, J. A. Goas, and M. Zheng. 2004. “Long-term Efficacy of Zoledronic Acid for the Prevention of Skeletal Complications in Patients with Metastatic Hormone-refractory Prostate Cancer”. JNCI Journal of the National Cancer Institute. Oxford University Press (OUP). doi:10.1093/jnci/djh141.
- 2022. "Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05534321.
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