Margin-Based Vs. Robust Photon Radiotherapy Planning in IMRT of HN-SQCC

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Description

This is a prospective randomized pilot clinical trial, stratified by primary tumor site, to evaluate the degree of xerostomia and quality of life (QOL) in subjects with HN-SQCC treated with radiation therapy under margin-based and robust radiotherapy treatment plans. Margin-based plans will use both...

This is a prospective randomized pilot clinical trial, stratified by primary tumor site, to evaluate the degree of xerostomia and quality of life (QOL) in subjects with HN-SQCC treated with radiation therapy under margin-based and robust radiotherapy treatment plans. Margin-based plans will use both biological (biological optimization) and physical objectives whereas robust planning will use physical objectives for sparing of the parotid glands. Intensity-modulated radiation therapy (IMRT) and standard chemotherapy will be used. QOL (quality of life) will be measured using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 questionnaire and EORTC QLQ-H&N35 (head and neck) module before radiotherapy (baseline) and then 3, 6, 9 and 12 months after radiotherapy. Xerostomia will be measured in study subjects using two patient-reported scoring systems completed by each subject before radiotherapy and then 3, 6, 9, and 12 months after radiotherapy: Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) LENT/SOMA grading system and the University of Michigan's Xerostomia Questionnaire (XQ). The data collected by this randomized pilot clinical trial will be used to inform the design of, and decision-making for, future larger studies that seek to compare different methods of radiotherapy planning in the treatment of HN-SQCC.

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