Journal article
The Surveillance After Extremity Tumor Surgery (SAFETY) trial: protocol for a pilot study to determine the feasibility of a multi-centre randomised controlled trial
BMJ open, Vol.9(9), pp.e029054-e029054
09/01/2019
DOI: 10.1136/bmjopen-2019-029054
PMCID: PMC6756324
PMID: 31537562
Abstract
Introduction Following the treatment of patients with soft tissue sarcomas (STS) that are not metastatic at presentation, the high risk for local and systemic disease recurrence necessitates post-treatment surveillance. Systemic recurrence is most often detected in the lungs. The most appropriate surveillance frequency and modality remain unknown and, as such, clinical practice is highly varied. We plan to assess the feasibility of conducting a multi-centre randomised controlled trial (RCT) that will evaluate the effect on overall 5-year survival of two different surveillance frequencies and imaging modalities in patients with STS who undergo surgical excision with curative intent.
Methods and analysis The Surveillance After Extremity Tumor Surgery trial will be a multi-centre 2x2 factorial RCT. Patients with non-metastatic primary Grade II or III STS treated with excision will be allocated to one of four treatment arms(1): chest radiograph (CXR) every 3 months for 2 years(2); CXR every 6 months for 2 years(3); chest CT every 3 months for 2 years or(4) chest CT every 6 months for 2years. The primary outcome of the pilot study is the feasibility of a definitive RCT based on a combination of feasibility endpoints. Secondary outcomes for the pilot study include the primary outcome of the definitive trial (overall survival), patient-reported outcomes on anxiety, satisfaction and quality of life, local recurrence-free survival, metastasis-free survival, treatment-related complications and net healthcare costs related to surveillance.
Ethics and dissemination This trial received provisional ethics approval from the McMaster/Hamilton Health Sciences Research Ethics Board on 7 August 2019 (Project number 7562). Final ethics approval will be obtained prior to commencing patient recruitment. Once feasibility has been established and the definitive protocol is finalised, the study will transition to the definitive study.
Details
- Title: Subtitle
- The Surveillance After Extremity Tumor Surgery (SAFETY) trial: protocol for a pilot study to determine the feasibility of a multi-centre randomised controlled trial
- Creators
- Michelle Ghert - McMaster Univ, Dept Surg, Hamilton, ON, CanadaMohit Bhandari - McMaster Univ, Dept Surg, Hamilton, ON, CanadaAnthony Bozzo - McMaster Univ, Dept Surg, Hamilton, ON, CanadaP. D. Sander Dijkstra - Leiden Univ, Med Ctr, Dept Orthopaed, Leiden, NetherlandsAnthony Griffin - Mt Sinai Hosp, Musculoskeletal Oncol Unit, Toronto, ON, CanadaRobert Grimer - Univ Birmingham, Dept Surg, Birmingham, W Midlands, EnglandJames Hayden - Oregon Hlth & Sci Univ, Dept Orthopaed & Rehabil, Portland, OR 97201 USAArlene Manherz - McMaster Univ, Dept Surg, Hamilton, ON, CanadaKarim Masrouha - McMaster Univ, Dept Surg, Hamilton, ON, CanadaPaula McKay - McMaster Univ, Dept Surg, Hamilton, ON, CanadaBenjamin Miller - Univ Iowa, Dept Orthopaed & Rehabil, Iowa City, IA USANaveen Parasu - McMaster Univ, Dept Radiol, Hamilton, ON, CanadaAjay Puri - Tata Mem Hosp, Dept Surg Oncol, Mumbai, Maharashtra, IndiaR. Lor Randall - Univ Calif Davis, Dept Orthopaed Surg, Sacramento, CA 95817 USAPatricia Schneider - McMaster Univ, Dept Surg, Hamilton, ON, CanadaSheila Sprague - McMaster Univ, Dept Surg, Hamilton, ON, CanadaNina Szpakowski - McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, CanadaLehana Thabane - McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, CanadaRobert Turcotte - McGill Univ, Dept Surg, Montreal, PQ, CanadaRoberto Velez - Hosp Valle De Hebron, Dept Orthopaed Surg, Barcelona, Catalunya, SpainDavid Wilson - McMaster Univ, Dept Surg, Hamilton, ON, CanadaKevin Zbuk - McMaster Univ, Dept Oncol, Hamilton, ON, CanadaGordon Guyatt - McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, CanadaSAFETY Investigators
- Resource Type
- Journal article
- Publication Details
- BMJ open, Vol.9(9), pp.e029054-e029054
- DOI
- 10.1136/bmjopen-2019-029054
- PMID
- 31537562
- PMCID
- PMC6756324
- NLM abbreviation
- BMJ Open
- ISSN
- 2044-6055
- eISSN
- 2044-6055
- Publisher
- Bmj Publishing Group
- Number of pages
- 10
- Grant note
- Canadian Cancer Society Research Institute (CCSRI) Innovation Grants Hamilton Academic Health Science Organiza-tion (HAHSO)
- Language
- English
- Date published
- 09/01/2019
- Academic Unit
- Orthopedics and Rehabilitation
- Record Identifier
- 9984304684802771
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