Abstract
BackgroundLong-term locoregional control in locally advanced squamous cell carcinoma of the head and neck (SCCHN) remains challenging. While recent years have seen various approaches to improve outcome by intensification of treatment schedules through introduction of novel induction and combination chemotherapy regimen and altered fractionation regimen, patient tolerance to higher treatment intensities is limited by accompanying side-effects. Combined radioimmunotherapy with cetuximab as well as modern radiotherapy techniques such as intensity-modulated radiotherapy (IMRT) and carbon ion therapy (C12) are able to limit toxicity while maintaining treatment effects. In order to achieve maximum efficacy with yet acceptable toxicity, this sequential phase II trial combines induction chemotherapy with docetaxel, cisplatin, and 5-FU (TPF) followed by radioimmunotherapy with cetuximab as IMRT plus carbon ion boost. We expect this approach to result in increased cure rates with yet manageable accompanying toxicity.Methods/designThe TPF-C-HIT trial is a prospective, mono-centric, open-label, non-randomized phase II trial evaluating efficacy and toxicity of the combined treatment with IMRT/carbon ion boost and weekly cetuximab in 50 patients with histologically proven locally advanced SCCHN following TPF induction chemotherapy. Patients receive 24 GyE carbon ions (8 fractions) and 50 Gy IMRT (2.0 Gy/fraction) in combination with weekly cetuximab throughout radiotherapy. Primary endpoint is locoregional control at 12 months, secondary endpoints are disease-free survival, progression-free survival, overall survival, acute and late radiation effects as well as any adverse events of the treatment as well as quality of life (QoL) analyses.DiscussionThe primary objective of TPF-C-HIT is to evaluate efficacy and toxicity of cetuximab in combination with combined IMRT/carbon ion therapy following TPF induction in locally advanced SCCHN.Trial RegistrationClinical Trial Identifier: NCT01245985 (clinicaltrials.gov)EudraCT number: 2009 - 016489- 10
Highlights
Long-term locoregional control in locally advanced squamous cell carcinoma of the head and neck (SCCHN) remains challenging
Radiochemotherapy Platinum-containing radiochemotherapy is the current standard of care in the conservative treatment approach for locally advancend squamous cell carcinoma of the head and neck (SCCHN) [1]
In order to further improve local control for these patients after standard induction chemotherapy with three cycles of docetaxel/cisplatin/5-FU (TPF), raster-scanned carbon ion therapy, and radioimmunotherapy as intensity-modulated radiotherapy (IMRT) as the so far most effective treatment components are combined in order to achieve the best possible results
Summary
With the introduction of novel radiotherapy techniques such as IMRT and particle therapy (neutron and carbon ion therapy), higher local control rates in radioresistant tumours such as adenoid cystic carcinoma could be achieved over the last decade [15,16]. There are various options to intensify treatment for patients with locally advanced head and neck tumours: modern radiotherapy techniques provide tools for relative dose escalation within the tumour, particle therapy may further improve local control by increased biological effectiveness, and induction chemotherapy improves long-term survival in these patients. All of these treatment approaches have shown clinical feasibility and efficacy as single modalities. This is the first clinical trial evaluation this trimodal treatment regimen
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