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

Lambrecht, M.; Clementel, E.; Sonke, Jan‐Jakob; Nestle, Ursula; Adebahr, S.; Gückenberger, Matthias; Andratschke, Nicolaus; Weber, Damien Charles; Verheij, Marcel; Hurkmans, Coen

doi:10.1016/j.radonc.2018.10.025

Cited by 13 publications

(14 citation statements)

References 14 publications

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“…A robust QA process is particularly important in the setting of high dose per fraction radiotherapy, where small differences in actual versus expected dose can result in significant toxicities to normal tissue. This has been emphasized in previous studies involving hypofractionation [ 25 ]. Consistent review is therefore considered invaluable in this trial and resulted in substantial changes to the workflow process thus far.…”

Section: Discussionmentioning

confidence: 84%

A pilot study of stereotactic boost for malignant epidural spinal cord compression: clinical significance and initial dosimetric evaluation

et al. 2020

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Purpose Metastatic epidural spinal cord compression (MESCC) is a devastating complication of advanced malignancy, which can result in neurologic complications and significant deterioration in overall function and quality of life. Most patients are not candidates for optimal surgical decompression and as a result, receive urgent 3D conformal radiotherapy (3DCRT) to prevent or attempt to reverse neurologic progression. Multiple trials indicate that response and ambulatory rates after 3DCRT are inferior to surgery. The advent of stereotactic body radiation therapy (SBRT) has created a method with which a “radiosurgical decompression” boost may facilitate improve outcomes for MESCC patients. Methods We are conducting a pilot study to investigate SBRT boost after urgent 3D CRT for patients with MESCC. The aim of the study is to establish feasibility of this two-phase treatment regimen, and secondarily to characterize post-treatment ambulation status, motor response, pain control, quality of life and survival. Discussion We describe the study protocol and present a case report of one patient. A quality assurance review was conducted after the first seven patients, and resultant dose-constraints were revised to improve safety and feasibility of planning through more conservative organ at risk constraints. There have been no severe adverse events (grade 3–5) to date. We have illustrated clinical and dosimetric data of an example case, where a patient regained full strength and ambulatory capacity. Conclusions Our study aims to determine if SBRT is a feasible option in addition to standard 3DCRT for MESCC patients, with the goal to consider future randomized trials if successful. Having a robust quality assurance process in this study ensures translatability going forward if future trials with multicenter and increased patient representation are to be considered. Trial registration clinicaltrials.gov; registration no. NCT03529708; https://clinicaltrials.gov/ct2/show/NCT03529708; First posted May 18, 2018.

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Section: Discussionmentioning

confidence: 84%

A pilot study of stereotactic boost for malignant epidural spinal cord compression: clinical significance and initial dosimetric evaluation

et al. 2020

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“…This highlights the importance of commencing a thorough QAprogramme before initiating multi-centre trials, minimizing these variabilities. Additionally, the QA-programme should be followed by checks throughout the trial period [9,11,14]. In this study, we prospectively store clinical data and treatment plans, making the data immediately available for analysis in case high rates of severe toxicity require the trial to be halted.…”

Section: Discussionmentioning

confidence: 99%

“…The dosimetric effect of variations in tumour delineations, was investigated as part of the pre-trial QA of the Lungtech trial. It was found that delineation variations lead to higher dosimetric variability than variations in the multi-centre treatment plans [9,14]. Over-dosage of the heart was observed in a retrospective evaluation of delineations submitted for the CONVERT trial.…”

Section: Discussionmentioning

confidence: 99%

“…A metaanalysis from 2019 estimated the risk of grade 3 toxicity after SBRT of central NSCLC to 12% [6].The high risk of lethal toxicity, calls for high demands to study design and quality assurance (QA). For clinical trials with multi-centre collaboration, it is important to secure consistent delineation of target and OAR in addition to consensus on the dose delivery as more coherent interpretation of the trial outcome is obtained by standardisation prior to trial initiation [9][10][11][12][13][14][15]. However, trial QA may be insufficient and is often unpublished [1,4,16].…”

Section: Introductionmentioning

confidence: 99%

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Thorough design and pre-trial quality assurance (QA) decrease dosimetric impact of delineation and dose planning variability in the STRICTLUNG and STARLUNG trials for stereotactic body radiotherapy (SBRT) of central and ultra-central lung tumours

Hoffmann

Persson

Nygård

et al. 2022

Radiotherapy and Oncology

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“…However, 9 cardiac and unknown causes of death in a group of 63 patients elicits caution about the true extent of the risk of major toxicity that may accompany this schedule (56). Results on the safety of this approach from prospective trials, such as the EORTC Lungtech trial (57,58) and the Canadian Sunset trial (59) are eagerly awaited.…”

Section: Hypofractionation: Sbrtmentioning

confidence: 99%

Dose and fractionation schedules in radiotherapy for non-small cell lung cancer

Kępka¹,

Socha²

2021

Transl Lung Cancer Res

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In the field of radiotherapy (RT), the issues of total dose, fractionation, and overall treatment time for non-small cell lung cancer (NSCLC) have been extensively investigated. There is some evidence to suggest that higher treatment intensity of RT, when given alone or sequentially with chemotherapy (CHT), is associated with improved survival. However, there is no evidence that the outcome is improved by RT at a higher dose and/or higher intensity when it is used concurrently with CHT. Moreover, some reports on the combination of full dose CHT with a higher biological dose of RT warn of the significant risk posed by such intensification. Stereotactic body radiotherapy (SBRT) provides a high rate of local control in the management of early-stage NSCLC through the use of high ablative doses. However, in centrally located tumors the use of SBRT may carry a risk of serious damage to the great vessels, bronchi, and esophagus, owing to the high ablative doses needed for optimal tumor control. There is a similar problem with moderate hypofractionation in radical RT for locally advanced NSCLC, and more evidence needs to be gathered regarding the safety of such schedules, especially when used in combination with CHT. In this article, we review the current evidence and questions related to RT dose/fractionation in NSCLC.

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

Cited by 13 publications

References 14 publications

A pilot study of stereotactic boost for malignant epidural spinal cord compression: clinical significance and initial dosimetric evaluation

A pilot study of stereotactic boost for malignant epidural spinal cord compression: clinical significance and initial dosimetric evaluation

Thorough design and pre-trial quality assurance (QA) decrease dosimetric impact of delineation and dose planning variability in the STRICTLUNG and STARLUNG trials for stereotactic body radiotherapy (SBRT) of central and ultra-central lung tumours

Dose and fractionation schedules in radiotherapy for non-small cell lung cancer

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