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1.
Lancet Oncol ; 25(7): e318-e330, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38936390

RESUMO

Robust time-to-event endpoint definitions are crucial for the assessment of treatment effect and the clinical value of trial interventions. Here, the Head and Neck Cancer International Group investigated endpoint use in phase 3 trials and trials considered potentially practice-changing published between 2008 and 2021 in the curative-intent setting for patients with mucosal head and neck squamous cell carcinoma. Of the 92 trials reviewed, we show that all core components of endpoint reporting were heterogeneous, including definitions of common terms, such as overall survival and progression-free survival. Our report highlights the urgent need for harmonisation of fundamental components of clinical trial endpoints and the engagement of all stakeholders to ensure the transparent reporting of endpoint details.


Assuntos
Consenso , Determinação de Ponto Final , Neoplasias de Cabeça e Pescoço , Carcinoma de Células Escamosas de Cabeça e Pescoço , Humanos , Carcinoma de Células Escamosas de Cabeça e Pescoço/patologia , Carcinoma de Células Escamosas de Cabeça e Pescoço/terapia , Carcinoma de Células Escamosas de Cabeça e Pescoço/mortalidade , Neoplasias de Cabeça e Pescoço/terapia , Neoplasias de Cabeça e Pescoço/patologia , Neoplasias de Cabeça e Pescoço/mortalidade , Determinação de Ponto Final/normas , Ensaios Clínicos Fase III como Assunto , Intervalo Livre de Progressão
2.
Int J Radiat Oncol Biol Phys ; 67(5): 1430-7, 2007 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-17208385

RESUMO

INTRODUCTION: We have assessed the planning target volume (PTV) margins required for adequate treatment of the prostate in the absence of daily localization imaging based on the statistical analysis of a large data set obtained from 5 years of use of a two-dimensional ultrasound pretreatment localization device. METHODS AND MATERIALS: Data from 387 prostate patients were analyzed retrospectively. Every patient in the study received daily pretreatment localization resulting in a total of 10,327 localizations, each comprising an isocenter displacement in three directions: anteroposterior, right-left lateral, and superior-inferior. The mean displacement for each direction for each patient was computed from daily treatment records, and a mean of the means was used in the analysis. RESULTS: The mean displacements required to shift the target to the required position were 6.1 mm posterior (4.4 mm SD), 2.1 mm superior (4.5 mm SD), and 0.5 mm right (3.6 mm SD). The 6.1-mm shift posterior is indicative of a systematic uncertainty. Differences in planning conditions between the computed tomography simulation and the treatment room may account for this discrepancy. CONCLUSION: Our study has revealed systematic intertreatment uncertainties that would have required a nonuniform PTV margin ranging in dimensions between 2.7 mm anterior, 14.9 mm posterior, 7.7 mm right, 6.7 mm left, 11 mm superior, and 7 mm inferior to encompass the prostate for 95% of our sample if the ultrasound localization system were not used. In the absence of systematic uncertainties, a uniform PTV margin of 9 mm would suffice.


Assuntos
Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/radioterapia , Radioterapia Conformacional , Humanos , Masculino , Movimento , Estudos Retrospectivos , Tomografia Computadorizada por Raios X , Ultrassonografia
3.
Med Phys ; 32(9): 2976-86, 2005 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-16266112

RESUMO

Energy modulated electron therapy (EMET) based on Monte Carlo dose calculation is a promising technique that enhances the treatment planning and delivery of superficially located tumors. This study investigated the application of EMET using a novel few-leaf electron collimator (FLEC) in head and neck and breast sites in comparison with three-dimensional conventional radiation therapy (3D-CRT) and intensity modulated radiation therapy (IMRT) techniques. Treatment planning was performed for two parotid cases and one breast case. Four plans were compared for each case: 3D-CRT, IMRT, 3D-CRT in conjunction with EMET (EMET-CRT), and IMRT in conjunction with EMET (EMET-IMRT), all of which were performed and calculated with Monte Carlo techniques. For all patients, dose volume histograms (DVHs) were obtained for all organs of interest and the DVHs were used as a means of comparing the plans. Homogeneity and conformity of dose distributions were calculated, as well as a sparing index that compares the effect of the low isodose lines. In addition, the whole-body dose equivalent (WBDE) was estimated for each plan. Adding EMET delivered with the FLEC to 3D-CRT improves sparing of normal tissues. For the two head and neck cases, the mean dose to the contralateral parotid and brain stem was reduced relative to IMRT by 43% and 84%, and by 57% and 71%, respectively. Improved normal tissue sparing was quantified as an increase in sparing index of 47% and 30% for the head and neck and the breast cases, respectively. Adding EMET to either 3D-CRT or IMRT results in preservation of target conformity and dose homogeneity. When adding EMET to the treatment plan, the WBDE was reduced by between 6% and 19% for 3D-CRT and by between 21% and 33% for IMRT, while WBDE for EMET-CRT was reduced by up to 72% when compared with IMRT. FLEC offers a practical means of delivering modulated electron therapy. Although adding EMET delivered using the FLEC results in perturbation of target conformity when compared to IMRT, it significantly improves normal tissue sparing while offering enhanced target conformity to the 3D-CRT planning. The addition of EMET systematically leads to a reduction in WBDE especially when compared with IMRT.


Assuntos
Neoplasias da Mama/radioterapia , Elétrons , Neoplasias Parotídeas/radioterapia , Planejamento da Radioterapia Assistida por Computador , Feminino , Humanos , Método de Monte Carlo , Radioterapia Conformacional , Radioterapia de Alta Energia , Tomografia Computadorizada por Raios X
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