DAHANCA 9 - a randomized multicenter study to compare accelerated normo-fractionated radiotherapy with accelerated hyperfractionated radiotherapy in patients with primary squamous cell carcinoma of the head and neck (HNSCC)

摘要

Following the DAHANCA 5 trial [1], which demonstrated the benefit of the hypoxic radiosensitizer Nimorazole, and the DAHANCA 6&7 trial, which demonstrated that accelerated fractionation added significant improvement to the radiotherapy treatment of squamous cell carcinoma of the head and neck (HNSCC) [2,3], the DAHANCA group attempted to further improve the treatment of advanced head and neck cancer by an escalation of the total dose. Thus, the DAHANCA 9 study was designed to evaluate, in a prospective randomized trial, if the use of accelerated, hyperfractionated radiotherapy to a total dose of 76 Gy was feasible and superior to normo-fractionated (2Gy/fx) accelerated radiotherapy with a total dose of 66-68 Gy. Both regimes being supplemented with the hypoxic radiosensitizer Nimorazole [4-6]. Such dose escalation seems possible by reducing the dose per fraction (fx) while increasing the overall dose. This can be achieved with a hyperfractionated schedule, which gives a dose of 1.35 Gy per fraction given twice daily (10 fx per week) and within the same overall treatment time as normal fractionated accelerated treatment [7].