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. 2010 Dec 8;2010(12):CD006387. doi: 10.1002/14651858.CD006387.pub2

Moergel 2009.

Trial name or title  
Methods Non‐blinded, multicentre randomised controlled trial.
Participants Histologically verified diagnosis of a primary squamous cell carcinoma of the oral cavity or the oropharynx are eligible.
"‐ Maximum tumor diameter less than 4 cm in the pathohistological specimen irrespective of histological grading (pT1 or pT2)
‐ Concomitant histological verification of a singular ipsilateral lymph node metastasis less than 3 cm in diameter (pN1) without penetration of the lymph node's capsule and without presence of lymphangiosis carcinomatosa
‐ Radical resection of the tumor within adequate resection margins (R0)
‐ Written informed consent from the patient
‐ Adequate performance status ECOG Index greater or equal to 2
Patients younger than 18 and pregnant women are to be excluded."
Interventions Surgery plus radiotherapy versus surgery alone.
Outcomes Primary outcome: overall survival.
Secondary outcomes: incidence and time to tumour relapse, quality of life and time from surgery to orofacial rehabilitation.
Starting date September 2009.
Contact information Maximilian Moergel (moergel@mkg.klinik.uni‐mainz.de).
Notes