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.

Highlights

  • The last 20 years has seen the emergence of novel anticancer treatments which have the potential to improve clinical outcomes for patients

  • This article reviews the literature on Target volume delineation (TVD) variability and its impact on dosimetry and clinical outcomes

  • Examples include intensity-modulated radiotherapy (IMRT), which allows the radiotherapy dose to be conformed to the target volume while sparing nearby organs at risk (OAR), and image-guided radiotherapy, which improves the precision of treatment delivery and allows smaller margins to be added to the target volume for delivery uncertainty [3]

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Summary

Challenges for Quality Assurance of Target volume Delineation in Clinical Trials

Reviewed by: Stefan Rieken, University Hospital Heidelberg, Germany Paul Stephen Rava, UMass Memorial Medical Center, United States. New radiotherapy techniques have emerged that aim to improve treatment outcome and reduce toxicity. 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. Many studies have shown large inter-observer variations in contouring, both within and outside of clinical trials. High precision techniques, such as intensitymodulated radiotherapy, image-guided brachytherapy, and stereotactic radiotherapy have steep dose gradients, and errors in contouring may lead to inadequate dose to the tumor and reduce the chance of cure. This article reviews the literature on TVD variability and its impact on dosimetry and clinical outcomes. Specialty section: This article was submitted to Radiation Oncology, a section of the journal

INTRODUCTION
MAGNITUDE OF TVD VARIABILITY
CAUSES OF TVD VARIABILITY
ASSESSMENT OF TVD VARIABILITY
DOSIMETRIC IMPACT OF TVD
CLINICAL IMPACT OF TVD VARIABILITY
Contouring Guidelines and Atlases
Contouring Workshops and Educational Programs
Peer Review
MINIMIZING TVD VARIABILITY IN CLINICAL TRIALS
Findings
DISCUSSION
Full Text
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