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DAHANCA 16

DAHANCA.dk The Danish Head and Neck Cancer Study Group. DAHANCA 16 Planned post-radiation neck dissection vs salvage neck dissection in patients with N2-3 SCC of the head and neck treated with primary radiotherapy. DAHANCA 16.

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DAHANCA 16

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  1. DAHANCA.dk The Danish Head and Neck Cancer Study Group DAHANCA 16 Planned post-radiation neck dissection vs salvage neck dissection in patients with N2-3 SCC of the head and neck treated with primary radiotherapy

  2. DAHANCA 16 Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx T1-T4, N2N3 (unilat) M0 Candiate for primary RT±chemo Stratify: Institution Gender Site T-stage N-stage RANDOMIZE Radiotherapy followed by observation. Salvage neck dissection in case of recurrence Radiotherapy followed by planned neck dissection 6 weeks after completion of RT

  3. DAHANCA 16 • Endpoints: • Primary: Persistent regional control (N-site) • Secondary: Local control (T-site) • Loco-regional control • Disease-specific & overall survival • CT-scan • Side effects, QoL • Statistics: Isolated N-failure improvement from 25% to 10% -> 60 events, 300 patients

  4. DAHANCA 16 Patient selection criteria: • Histological proven SCC in the oral cavity, oropharynx, hypopharynx or larynx, TNM classification T1-T4, N2a, N2b, N2c contralateral or N3 unilateral, M0. • Planned primary curative intended radiotherapy alone or combined chemo-radiotherapy • No cervical lymph node metastases of squamous cell carcinoma from an unknown primary (CUP) • Radiotherapy must start within 3 weeks after randomisation • No prior treatment of the head and neck • No previous or current malignancies affecting the current treatment, evaluation or outcome • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomisation in the trial • Age > 18 years • WHO performance status 0-2 • Written informed consent must be obtained and documented according to local and national regulations

  5. DAHANCA 16 Evaluation after the end of treatment: • The first year: 1, 2, 5, 8 and 12 months after completion of radiotherapy. • Second year: At least every four months • From the third to the fifth year: At least every six months • Quality of life (EORTC QLQ-C30 and HN35) 1, 2, 5, 8 and 12 months after completion of radiotherapy

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