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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.dkThe Danish Head and Neck Cancer Study Group

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

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Radiotherapy followed by observation. Salvage neck dissection in case of recurrence

Radiotherapy followed by planned neck dissection 6 weeks after completion of RT

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Endpoints:

Primary: Persistent regional control (N-site)

Secondary: Local control (T-site)Loco-regional controlDisease-specific & overall

survivalCT-scanSide effects, QoL

Statistics: Isolated N-failure improvement from 25% to 10% -> 60

events, 300 patients

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

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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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