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DAHANCA 37. Re-irradiation With Proton Radiotherapy

NCT03981068 NA UNKNOWN

Summary Design Phase II observational Treatment * 60 Gy/50 fx / 10W-1 at 1.2 Gy/fx o i.e. EQD2 tumor=56 Gy, EQD2 late=50.4 Gy at α/β= 10 and 3, respectively * Proton radiotherapy * Concomitant cisplatin for eligible patients\* * Nimorazole recommended for SCC\* \*The concurrent medical treatment (weekly cisplatin and nimorazole) are prescribed according to the national treatment guidelines, and are not part of the experimental treatment. Endpoints * Primary: o Any new late toxicity grade \>=3 according to CTC AE 5.0 * Secondary * Side effects according to DAHANCA scoring system * Quality of life and PROM according to EORTC C30 and HN43 * Loco-regional control (LRC) * Overall survival (OS)

Details

Lead sponsorDanish Head and Neck Cancer Group
PhaseNA
StatusUNKNOWN
Enrolment20
Start dateSun Sep 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionSat Aug 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

Denmark