ARTFORCE Head & Neck study
Research type
Research Study
Full title
A randomized study with cisplatinum or cetuximab and standard or adaptive high dose radiotherapy for advanced head and neck cancer.
IRAS ID
125962
Contact name
Nicholas Slevin
Contact email
Sponsor organisation
The Netherlands Cancer Institute (NKI)
Eudract number
2012-000437-39
Clinicaltrials.gov Identifier
Research summary
The standard non-surgical treatment for locally advanced head and neck cancer is radiotherapy with synchronous cisplatinum. For patients unsuitable for synchronous platinum chemotherapy, synchronous cetuximab confers a similar level of improved local control as does cytotoxic chemotherapy. Failure of locoregional control remains the main reason for recurrence in these patients and is predominantly within the high dose area of the radiation treatment. This study will investigate the locoregional recurrence free survival in patients receiving either standard radiotherapy versus adaptive high dose radiotherapy, and either cisplatinum or cetuximab. High dose adaptive radiotherapy provides the next logical step in radiotherapy for head and neck cancer, as higher doses will reduce the likelihood of tumour recurrence. It allows the highest dose to be targeted to where it is needed most. Both cisplatinum and cetuximab have been shown to be equivalent in improving tumour control, but each can have severe side effects. Therefore there is a need to select which of these systemic treatments is most appropriate, based on tumour characteristics to maximise control and reduce toxicity.
ARTFORCE is a randomised, four arm, phase II, unblinded, multicentre study aiming to recruit a total of 268 patients, throughout the EU, with locally advanced squamous cell carcinoma of the head and neck. Patients will be randomised into four arms receiving either cisplatinum or cetuximab, and either standard or high dose adaptive radiotherapy delivered over six weeks. Seven days prior to this treatment all patients will receive a single dose of Zirconium-89 (radiolabelled)-cetuximab together with a standard loading dose of cetuximab followed by a PET scan to visualise the uptake of the Zr-89-cetuximab within the tumour. All patients will complete toxicity and quality of life assessments throughout the study and five year follow-up to provide data regarding toxicity, quality of life, progression free and overall survival.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
13/NW/0497
Date of REC Opinion
25 Oct 2013
REC opinion
Further Information Favourable Opinion