Do selective radiation dose escalation and tumour hypoxia status impact the loco-regional tumour control after radio-chemotherapy of head and neck tumours The ESCALOX protocolReportar como inadecuado

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Radiation Oncology

, 12:45

First Online: 01 March 2017Received: 30 December 2016Accepted: 06 February 2017DOI: 10.1186-s13014-017-0776-1

Cite this article as: Pigorsch, S.U., Wilkens, J.J., Kampfer, S. et al. Radiat Oncol 2017 12: 45. doi:10.1186-s13014-017-0776-1


BackgroundStandard of care primary treatment of carcinoma of locally advanced squamous cell head and neck cancer LAHNSCC consists of platinum-based concomitant chemo-irradiation. Despite progress in the treatment of LAHNSCC using modern radiotherapy techniques the outcome remains still poor. Using IMRT with SIB the escalation of total dose to the GTV is possible with the aim to improve clinical outcome. This study tests the hypothesis if radiation dose escalation to the GTV improves 2-year-LRC and -OS after concomitant chemo-irradiation.

MethodsThe ESCALOX trial is a prospective randomized phase III study using cisplatin chemo-irradiation and the SIB-IMRT concept in patients with LAHNSCC of the oral cavity, oropharynx or hypopharynx to escalate the total dose to the GTV up to 80.5 Gy. Chemotherapy is planned either in the 1 and 5 week cisplatin 20 mg-m-d d 1–5 and d 29–33 or weekly cisplatin 40 mg-m-d during RT. RT is delivered as SIB with total doses of 80.5 Gy-70.0 Gy-56.0 Gy with 2.3 Gy-2.0 Gy and 1.6 Gy in the experimental arm and in the control arm with 70.0 Gy-56.0 Gy with 2.0 Gy and 1.6 Gy. A pre-study with dose escalation up to 77.0 Gy-70.0 Gy-56.0 Gy with 2.2 Gy-2.0 Gy and 1.6 Gy is demanded by the German federal office of radiation protection BfS. In the translational part of the trial 100 of the randomised patients will be investigated by 18-F-FMiso-PET-CT for the presence and behaviour of tumor hypoxia twice in the week before treatment start.

DiscussionThe primary endpoint of the pre-study is acute radiation induced toxicity. Primary endpoint of the main trial is 2-year-LRC. By using the dose escalation up to 80.5 Gy to the GTV of the primary tumor and lymph nodes > 2 cm a LRC benefit of 15% at 2 years should be expected. The ESCALOX trial is supported by Deutsche Forschungsgemeinschaft DFG; Grant No.: MO-363-4-1.

Trial Identifier: NCT 01212354, EudraCT-No.: 2010-021139-15

KeywordsDose escalation Randomized prospective trial Head and neck cancer Chemo-irradiation AbbreviationsAFAccelerated Fractionation

AF + ccbAccelerated Fractionation with Concomitant Boost

AROArbeitsgemeinschaft Radioonkolgie

AUCArea under the curve

BfArMBundesinstitut für Arzneimittel und Medizinprodukte German Federal Institute for Drugs and Medical Devices

BfSBundesamt für Strahlenschutz German Federal Office of Radiation Protection


CTCAECommon Toxicity Criteria Adverse Events

CTVClinical Target Volume

DFSDisease Free Survival

DVHDose Volume Histogram



GTVGross Target Volume



IITInvestigator initiated trial

IMRTIntensity Modulated Radiotherapy

IMSEInstitut für Medizinische Statistik und Epidemiologie

iRTInstitut für Innovative Radiotherapie

LAHNSCCLocally Advanced Head and Neck Squamous Cell Cancer

LRCLoco-regional Control

MRIMagnetic Resonance Imaging

MSZMünchner Studienzentrum


OAROrgans at Risk

OSOverall Survival

PETPositron Emission Tomography

PFSProgression Free Survival

PTVPlanning Target Volume


RTOGRadiation Therapy Oncology Group

SIBSimultaneous Integrated Boost

VMATVolumetric Arc Therapy

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Autor: Steffi U. Pigorsch - Jan J. Wilkens - Severin Kampfer - Victoria Kehl - Alexander Hapfelmeier - Christian Schläger - Henn


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