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 |