Challenges for Quality Assurance of Target Volume Delineation in Clinical Trials

In recent years, new radiotherapy techniques have emerged that aim to improve treatment outcome and reduce toxicity. The standard method of evaluating such techniques is to conduct large scale multicenter clinical trials, often across continents. A major challenge for such trials is quality assuranc...

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Published in:Frontiers in oncology Vol. 7; p. 221
Main Authors: Chang, Amy Tien Yee, Tan, Li Tee, Duke, Simon, Ng, Wai-Tong
Format: Journal Article
Language:English
Published: Switzerland Frontiers Media S.A 25-09-2017
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Abstract In recent years, new radiotherapy techniques have emerged that aim to improve treatment outcome and reduce toxicity. The standard method of evaluating such techniques is to conduct large scale multicenter clinical trials, often across continents. A major challenge for such trials is quality assurance to ensure consistency of treatment across all participating centers. Analyses from previous studies have shown that poor compliance and protocol violation have a significant adverse effect on treatment outcomes. The results of the clinical trials may, therefore, be confounded by poor quality radiotherapy. Target volume delineation (TVD) is one of the most critical steps in the radiotherapy process. Many studies have shown large inter-observer variations in contouring, both within and outside of clinical trials. High precision techniques, such as intensity-modulated radiotherapy, image-guided brachytherapy, and stereotactic radiotherapy have steep dose gradients, and errors in contouring may lead to inadequate dose to the tumor and consequently, reduce the chance of cure. Similarly, variation in organ at risk delineation will make it difficult to evaluate dose response for toxicity. This article reviews the literature on TVD variability and its impact on dosimetry and clinical outcomes. The implications for quality assurance in clinical trials are discussed.
AbstractList In recent years, new radiotherapy techniques have emerged that aim to improve treatment outcome and reduce toxicity. The standard method of evaluating such techniques is to conduct large scale multicenter clinical trials, often across continents. A major challenge for such trials is quality assurance to ensure consistency of treatment across all participating centers. Analyses from previous studies have shown that poor compliance and protocol violation have a significant adverse effect on treatment outcomes. The results of the clinical trials may, therefore, be confounded by poor quality radiotherapy. Target volume delineation (TVD) is one of the most critical steps in the radiotherapy process. Many studies have shown large inter-observer variations in contouring, both within and outside of clinical trials. High precision techniques, such as intensity-modulated radiotherapy, image-guided brachytherapy, and stereotactic radiotherapy have steep dose gradients, and errors in contouring may lead to inadequate dose to the tumor and consequently, reduce the chance of cure. Similarly, variation in organ at risk delineation will make it difficult to evaluate dose response for toxicity. This article reviews the literature on TVD variability and its impact on dosimetry and clinical outcomes. The implications for quality assurance in clinical trials are discussed.
Author Ng, Wai-Tong
Chang, Amy Tien Yee
Duke, Simon
Tan, Li Tee
AuthorAffiliation 3 Department of Oncology, Cambridge University Hospitals NHS Trust , Cambridge , United Kingdom
1 Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital , Hong Kong , Hong Kong
2 Department of Clinical Oncology, University of Hong Kong , Hong Kong
AuthorAffiliation_xml – name: 2 Department of Clinical Oncology, University of Hong Kong , Hong Kong
– name: 3 Department of Oncology, Cambridge University Hospitals NHS Trust , Cambridge , United Kingdom
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  fullname: Chang, Amy Tien Yee
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  givenname: Li Tee
  surname: Tan
  fullname: Tan, Li Tee
  organization: Department of Oncology, Cambridge University Hospitals NHS Trust, Cambridge, United Kingdom
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  givenname: Simon
  surname: Duke
  fullname: Duke, Simon
  organization: Department of Oncology, Cambridge University Hospitals NHS Trust, Cambridge, United Kingdom
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  givenname: Wai-Tong
  surname: Ng
  fullname: Ng, Wai-Tong
  organization: Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong, Hong Kong
BackLink https://www.ncbi.nlm.nih.gov/pubmed/28993798$$D View this record in MEDLINE/PubMed
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Keywords clinical trial
contouring guidelines
peer review
target volume delineation variability
education program
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Edited by: Stephanie E. Combs, Technische Universität München, Germany
Specialty section: This article was submitted to Radiation Oncology, a section of the journal Frontiers in Oncology
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Snippet In recent years, new radiotherapy techniques have emerged that aim to improve treatment outcome and reduce toxicity. The standard method of evaluating such...
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SubjectTerms clinical trial
contouring guidelines
education program
Oncology
peer review
target volume delineation variability
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Title Challenges for Quality Assurance of Target Volume Delineation in Clinical Trials
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