N. Groom

Protocol for the CONVERT trial—Concurrent ONce-daily VErsus twice-daily RadioTherapy: an international 2-arm randomised controlled trial of concurrent chemoradiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited stage small cell lung cancer (LS-SCLC) and good performance status

Introduction Concurrent ONce-daily VErsus twice-daily RadioTherapy (CONVERT) is the only multicentre, international, randomised, phase III trial open in Europe and Canada looking at optimisation of chemoradiotherapy (RT) in limited stage small cell lung cancer (LS-SCLC). Following on from the Turrisi trial of once-daily versus twice-daily (BD) concurrent chemoradiotherapy, there is a real need for a new phase III trial using modern conformal RT techniques and investigating higher once-daily radiation dose. This trial has the potential to define a new standard chemo-RT regimen for patients with LS-SCLC and good performance status. Methods and analysis 447 patients with histologically or cytologically proven diagnosis of SCLC were recruited from 74 centres in eight countries between 2008 and 2013. Patients were randomised to receive either concurrent twice-daily RT(45 Gy in 30 twice-daily fractions over 3 weeks) or concurrent once-daily RT(66 Gy in 33 once-daily fractions over 6.5 weeks) both starting on day 22 of cycle 1. Patients are followed up until death. The primary end point of the study is overall survival and secondary end points include local progression-free survival, metastasis-free survival, acute and late toxicity based on the Common Terminology Criteria for Adverse Events V.3.0, chemotherapy and RTdose intensity. Ethics and dissemination The trial received ethical approval from NRES Committee North West—Greater Manchester Central (07/H1008/229). There is a trial steering committee, including independent members and an independent data monitoring committee. Results will be published in a peer-reviewed journal and presented at international conferences. Trial registration number ISRCTN91927162; Pre-results.

Protocol for the isotoxic intensity modulated radiotherapy (IMRT) in stage III non-small cell lung cancer (NSCLC): a feasibility study

Introduction The majority of stage III patients with non-small cell lung cancer (NSCLC) are unsuitable for concurrent chemoradiotherapy, the non-surgical gold standard of care. As the alternative treatment options of sequential chemoradiotherapy and radiotherapy alone are associated with high local failure rates, various intensification strategies have been employed. There is evidence to suggest that altered fractionation using hyperfractionation, acceleration, dose escalation, and individualisation may be of benefit. The MAASTRO group have pioneered the concept of ‘isotoxic’ radiotherapy allowing for individualised dose escalation using hyperfractionated accelerated radiotherapy based on predefined normal tissue constraints. This study aims to evaluate whether delivering isotoxic radiotherapy using intensity modulated radiotherapy (IMRT) is achievable. Methods and analysis Isotoxic IMRT is a multicentre feasibility study. From June 2014, a total of 35 patients from 7 UK centres, with a proven histological or cytological diagnosis of inoperable NSCLC, unsuitable for concurrent chemoradiotherapy will be recruited. A minimum of 2 cycles of induction chemotherapy is mandated before starting isotoxic radiotherapy. The dose of radiation will be increased until one or more of the organs at risk tolerance or the maximum dose of 79.2 Gy is reached. The primary end point is feasibility, with accrual rates, local control and overall survival our secondary end points. Patients will be followed up for 5 years. Ethics and dissemination The study has received ethical approval (REC reference: 13/NW/0480) from the National Research Ethics Service (NRES) Committee North West—Greater Manchester South. The trial is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice (GCP). The trial results will be published in a peer-reviewed journal and presented internationally. Trial registration number NCT01836692; Pre-results.

Is pre-trial quality assurance necessary? Experiences of the CONVERT Phase III randomized trial for good performance status patients with limited-stage small-cell lung cancer

OBJECTIVE This study is an analysis of the pre-trial quality assurance (QA) exercises submitted by clinicians from radiotherapy (RT) centres across Europe and Canada to qualify for participation in the CONVERT trial. METHODS QA exercises submitted by 64 clinicians at 64 RT centres were included in this analysis. The exercises included the completion of a trial-specific questionnaire and submission of a treatment plan, for both trial arms, for a patient fitting the eligibility criteria of the trial. This article describes the QA programme set up for the CONVERT trial and identifies deviations from the trial protocol. Patient eligibility, disease and critical structure outlining and treatment planning technique were assessed. RESULTS Results from QA trial-specific questionnaires received between February 2008 and September 2011, returned as part of the QA exercise, indicated that the majority of centres (70.3%) were using 6-MV photons and type B treatment planning system algorithms (57.8%). 90.6% of clinicians assessed submitted data for patients who fitted the eligibility criteria for the trial. There were inconsistencies in outlining of gross tumour volume (GTV) and organs at risk, mainly heart and oesophagus, and in the use of margins around the GTV. CONCLUSION Such a QA programme helps to ensure that centres conform to trial protocol and should reduce inconsistencies in RT planning that may confound the results of the CONVERT trial. ADVANCES IN KNOWLEDGE Few studies reporting pre-trial QA have been published to date. This article outlines the importance of such a QA programme in the context of multicentre Phase III studies.

PO-0985: How accurate is lung IMRT and VMAT delivery? A multicentre audit as part of the Isotoxic IMRT trial

Conclusions: Results exhibited a good synchronization between 4D-PET and the system used to register the respiratory wave, accurate enough to use it for clinical purpose. For the 4 types of movement, the cranio-caudal displacement between the syringe from the 4D-PET and ANZAI were less than 2.30 mm. Moreover, mean difference showed that in most of the cases, curves were out of phase. This might lead to a systematic error in the tumour position. It could be interesting to run more measurements for different cycles and 4D-PET acquisitions if we want to modify the margins for the GTV due to the use of 4D-PET for tumor contouring.