Quality assurance in the randomized multicentre phase III trial EORTC-1709-BTG/CCTG CE.8 (MIRAGE) for glioblastoma: Results of the radiotherapy delineation benchmark case procedure.

Purpose: The multicentre randomised phase III trial EORTC-1709-BTG/CCTG CE.8 (MIRAGE) (NCT03345095) analysed the addition of the proteasome inhibitor marizomib to temozolomide-based chemoradiotherapy with 60 Gy in 30 fractions in patients with newly diagnosed glioblastoma. Here, we analysed the benchmark case procedure for delineation and planning radiotherapy quality assurance (RTQA) that was performed before patient inclusion.

Radiotherapy quality assurance for the PEACE 1 trial: An individual case review analysis.

Purpose: Radiotherapy quality assurance (RTQA) is essential for ensuring adherence to trial protocols. This paper summarizes the individual case review (ICR) results from the PEACE-1 trial, a phase-III study investigates standard of care (androgen deprivation therapy with or without docetaxel) with or without local radiotherapy; and with or without abiraterone acetate plus prednisone in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Materials And Methods: Participating institutions submitted radiotherapy (RT) plans for central review, assessing protocol compliance in target volume and organs at risk (OARs) delineation, as well as dose specifications.

Real-World Pattern-of-Care Analysis of Primary Cutaneous Lymphomas Radiation Therapy Among European Organisation for Research and Treatment of Cancer Members.

Purpose: We aim to determine the current treatment patterns and recommendations among physicians for cutaneous lymphomas and to identify the types of skin lymphomas for which existing radiation regimens need improvement.

Methods And Materials: A questionnaire from the European Organisation for Research and Treatment of Cancer was distributed to all members of the Cutaneous Lymphoma Tumour Group and Radiation Oncology Scientific Council. This online survey included 13 questions regarding treatment practices for patients with cutaneous lymphoma.

Stereotactic Body Radiotherapy for Centrally Located Inoperable Early-Stage NSCLC: EORTC 22113-08113 LungTech Phase II Trial Results.

Introduction: The international phase II single-arm LungTech trial 22113-08113 of the European Organization for Research and Treatment of Cancer assessed the safety and efficacy of stereotactic body radiotherapy (SBRT) in patients with centrally located early-stage NSCLC.

Methods: Patients with inoperable non-metastatic central NSCLC (T1-T3 N0 M0, ≤7cm) were included. After prospective central imaging review and radiation therapy quality assurance for any eligible patient, SBRT (8 × 7.

Assessment of bias in scoring of AI-based radiotherapy segmentation and planning studies using modified TRIPOD and PROBAST guidelines as an example.

Background And Purpose: Studies investigating the application of Artificial Intelligence (AI) in the field of radiotherapy exhibit substantial variations in terms of quality. The goal of this study was to assess the amount of transparency and bias in scoring articles with a specific focus on AI based segmentation and treatment planning, using modified PROBAST and TRIPOD checklists, in order to provide recommendations for future guideline developers and reviewers.

Materials And Methods: The TRIPOD and PROBAST checklist items were discussed and modified using a Delphi process.

Knowledge-based versus deep learning based treatment planning for breast radiotherapy.

Background And Purpose: To improve radiotherapy (RT) planning efficiency and plan quality, knowledge-based planning (KBP) and deep learning (DL) solutions have been developed. We aimed to make a direct comparison of these models for breast cancer planning using the same training, validation, and testing sets.

Materials And Methods: Two KBP models were trained and validated with 90 RT plans for left-sided breast cancer with 15 fractions of 2.

Health-related quality of life in men with oligometastatic prostate cancer following metastases-directed stereotactic body radiotherapy: Real-world data from the E-RADIatE OligoCare cohort.

Objective: To evaluate the impact of metastases-directed stereotactic body radiotherapy (SBRT) on health-related quality of life (HRQoL) in men with oligometastatic prostate cancer (PCa) using real-world data from the OligoCare cohort.

Materials And Methods: OligoCare is a pragmatic, observational cohort designed to assess the impact of metastases-directed SBRT on patients with oligometastatic disease (OMD). We report an interim analyses of the secondary endpoint HRQoL, assessed using the EORTC QLQ-C30, within six months of metastases-directed SBRT for oligometastatic disease in men with PCa among the first 1600 registered patients.

Recommendation on the technical and dosimetric data to be included in stereotactic body radiation therapy clinical trial publications based on a systematic review.

The results of phase II and III trials on Stereotactic Body Radiation Therapy (SBRT) increased adoption of SBRT worldwide. The ability to replicate clinical trial outcomes in routine practice depends on the capability to reproduce technical and dosimetric procedures used in the clinical trial. In this systematic review, we evaluated if peer-reviewed publications of clinical trials in SBRT reported sufficient technical data to ensure safe and robust implementation in real world clinics.

A Quality Control Study on Involved Node Radiation Therapy in the European Organisation for Research and Treatment of Cancer/Lymphoma Study Association/Fondazione Italiana Linfomi H10 Trial on Stages I and II Hodgkin Lymphoma: Lessons Learned.

Purpose: Involved node radiation therapy (INRT) was introduced in the European Organisation for Research and Treatment of Cancer/Lymphoma Study Association/Fondazione Italiana Linfomi H10 trial, a large multicenter trial in early-stage Hodgkin Lymphoma. The present study aimed to evaluate the quality of INRT in this trial.

Methods And Materials: A retrospective, descriptive study was initiated to evaluate INRT in a representative sample encompassing approximately 10% of all irradiated patients in the H10 trial.

Radiotherapy quality assurance in paediatric clinical trials: first report from six QUARTET-affiliated trials.

Background And Purpose: SIOP Europe's QUARTET project launched in 2016; aiming to improve access to high-quality radiotherapy for children and adolescents treated within clinical trials across Europe. The aim of this report is to present the profile of institutions participating in six QUARTET-affiliated trials and a description of the initial individual case review (ICR) outcomes.

Methods: This is a two-part analysis.

Tomotherapy for cranio-spinal irradiation.

Tomotherapy is a method of delivering rotational IMRT offering various advantages, notably for complex and large targets such as the cranio-spinal axis. This systematic literature review reports on main clinical outcomes and toxicities in patients with various cancer types that received whole craniospinal axis irradiation (CSI) using Tomotherapy and offers a comprehensive comparison between Tomotherapy and other radiotherapy delivery techniques. Databases including PubMed, PubMed Central, Embase, and Cochrane were searched using the keywords "tomotherapy" AND "craniospinal".

QUARTET: A SIOP Europe project for quality and excellence in radiotherapy and imaging for children and adolescents with cancer.

The European Society for Paediatric Oncology (SIOPE) Radiation Oncology Working Group presents the QUARTET Project: a centralised quality assurance programme designed to standardise care and improve the quality of radiotherapy and imaging for international clinical trials recruiting children and adolescents with cancer throughout Europe. QUARTET combines the paediatric radiation oncology expertise of SIOPE with the infrastructure and experience of the European Organisation for Research and Treatment of Cancer to deliver radiotherapy quality assurance programmes for large, prospective, international clinical trials. QUARTET-affiliated trials include children and adolescents with brain tumours, neuroblastoma, sarcomas including rhabdomyosarcoma, and renal tumours including Wilms' tumour.

Critical impact of radiotherapy protocol compliance and quality in the treatment of retroperitoneal sarcomas: Results from the EORTC 62092-22092 STRASS trial.

Background: The European Organization for Research and Treatment of Cancer 22092-62092 STRASS trial failed to demonstrate the superiority of neoadjuvant radiotherapy (RT) over surgery alone in patients with retroperitoneal sarcoma. Therefore, an RT quality-assurance program was added to the study protocol to detect and correct RT deviations. The authors report results from the trial RT quality-assurance program and its potential effect on patient outcomes.

Development of staffing, workload and infrastructure in member departments of the European Organisation for Research and Treatment of Cancer (EORTC) radiation oncology group.

Purpose: The EORTC Radiation Oncology Group uses a Facility Questionnaire (FQ) to collect information from its member radiation oncology departments. We analysed the FQ database for patient-related workload, staffing levels and infrastructure to determine developments in radiation oncology departments in the clinical trials community.

Materials & Methods: We exported the FQ database in August 2019.

Organ at risk delineation for radiation therapy clinical trials: Global Harmonization Group consensus guidelines.

Background And Purpose: The Global Quality Assurance of Radiation Therapy Clinical Trials Harmonization Group (GHG) is a collaborative group of Radiation Therapy Quality Assurance (RTQA) Groups harmonizing and improving RTQA for multi-institutional clinical trials. The objective of the GHG OAR Working Group was to unify OAR contouring guidance across RTQA groups by compiling a single reference list of OARs in line with AAPM TG 263 and ASTRO, together with peer-reviewed, anatomically defined contouring guidance for integration into clinical trial protocols independent of the radiation therapy delivery technique.

Materials And Methods: The GHG OAR Working Group comprised of 22 multi-professional members from 6 international RTQA Groups and affiliated organizations conducted the work in 3 stages: (1) Clinical trial documentation review and identification of structures of interest (2) Review of existing contouring guidance and survey of proposed OAR contouring guidance (3) Review of survey feedback with recommendations for contouring guidance with standardized OAR nomenclature.

Generalizability assessment of head and neck cancer NTCP models based on the TRIPOD criteria.

This review aimed to provide an overview of the level of maturity of normal tissue complication probability (NTCP) models for head and neck cancer (HNC) patients. A systematic literature review was performed to retrieve NTCP models for HNC toxicities. Patient population characteristics, NTCP model and the predictors, treatment technique and endpoint definition were extracted per article.

Impact of deviations in target volume delineation - Time for a new RTQA approach?

The international radiotherapy community has recognised that non-adherence to RT protocols can influence trial endpoints. However this conclusion is based on studies predominantly assessing the impact of deviations in dosimetric or treatment delivery protocol parameters rather than target volume delineation (TVD). This review evaluates the assessment of TVD within Radiation Therapy Quality Assurance (RTQA) programmes in clinical trials and the clinical impact of TVD protocol deviations.

Radiotherapy practice for paediatric brain tumours across Europe and quality assurance initiatives: Current situation, international survey and future perspectives.

Aim: The aim of the study is to analyse radiotherapy quality assurance (RTQA) processes in the treatment of paediatric central nervous system (CNS) tumours across Europe.

Methods: The RTQA aspects of major past and current European trials for paediatric CNS tumours were reviewed based on study protocols and publications. A survey among radiation oncologists and paediatric oncologists about the practices of RTQA in paediatric CNS tumours across European countries was also performed.

Radiotherapy quality assurance of SBRT for patients with centrally located lung tumours within the multicentre phase II EORTC Lungtech trial: Benchmark case results.

Purpose: To report on the benchmark case (BC) study performed in the context of the European Organisation for Research and Treatment of Cancer prospective multicentre Lungtech trial of SBRT for patients with inoperable centrally located lung tumours.

Methods And Materials: Target volume and organs at risk (OARs) delineations first needed to be acceptable before the treatment plan was reviewed. Retrospectively, Dice similarity coefficients of the OARs and the target volumes were calculated and a set of gold standard contours adapted for each institution margins was applied on the accepted dose submissions to evaluate the influence of acceptable delineation variations on dosimetry.

Radiotherapy quality assurance for the RTOG 0834/EORTC 26053-22054/NCIC CTG CEC.1/CATNON intergroup trial "concurrent and adjuvant temozolomide chemotherapy in newly diagnosed non-1p/19q deleted anaplastic glioma": Individual case review analysis.

Background: The EORTC phase III 26053-22054/ RTOG 0834/NCIC CTG CEC.1/CATNON intergroup trial was designed to evaluate the impact on concurrent and adjuvant temozolomide chemotherapy in newly diagnosed non-1p/19q deleted anaplastic gliomas. The primary endpoint was overall survival.

A virtual dosimetry audit - Towards transferability of gamma index analysis between clinical trial QA groups.

Purpose: Quality assurance (QA) for clinical trials is important. Lack of compliance can affect trial outcome. Clinical trial QA groups have different methods of dose distribution verification and analysis, all with the ultimate aim of ensuring trial compliance.