Radiotherapy related skin toxicity (RAREST-01): Mepitel? film versus standard care in patients with locally advanced head-and-neck cancer

摘要

The aim of the present trial is to investigate a new option of skin protection in order to reduce the rate of grade?≥?2 skin toxicity in patients receiving radiotherapy alone or radiochemotherapy for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN). This is a randomized, active-controlled, parallel-group multi-center trial that compares the following treatments of radiation dermatitis in patients with head-and-neck cancer: Mepitel? Film (Arm A) vs. standard care (Arm B). The primary aim of this trial is to investigate the rate of patients experiencing grade?≥?2 radiation dermatitis (according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03) until 50?Gy of radiotherapy. Evaluation until 50?Gy of radiotherapy has been selected as the primary endpoint, since up to 50?Gy, the irradiated volume includes the primary tumor and the bilateral cervical and supraclavicular lymph nodes, and, therefore, is similar in all patients. After 50?Gy, irradiated volumes are very individual, depending on location and size of the primary tumor, involvement of lymph nodes, and the treatment approach (definitive vs. adjuvant). In addition, the following endpoints will be evaluated: Time to grade 2 radiation dermatitis until 50?Gy of radiotherapy, rate of patients experiencing grade?≥?2 radiation dermatitis during radio(chemo)therapy, rate of patients experiencing grade?≥?3 skin toxicity during radio(chemo)therapy, adverse events, quality of life, and dermatitis-related pain. Administration of Mepitel? Film will be considered to be clinically relevant, if the rate of grade?≥?2 radiation dermatitis can be reduced from 85% to 65%. If administration of Mepitel? Film instead of standard care will be able to significantly reduce the rate of grade?≥?2 radiation dermatitis, it could become the new standard of skin care in patients irradiated for SCCHN. clinicaltrials.gov NCT03047174 . Registered on 26th of January, 2017. First patient included on 9th of May, 2017.