Cervical nodal metastasis is the most certain prognostic factor in oral cancer. Appropriate management of the neck is therefore of paramount importance in the treatment of oral cancer. However, there is still some controversy on the treatment of early maxillofacial malignancies. Currently, investigators have no accurate uniform treatment standards, including the National Comprehensive Cancer Network (NCCN) recommended between surgery and radiotherapy options. Clinical evaluation indicated that lymph node-negative patients eventually 25%-35% had cervical node metastasis. Therefore, for the majority of patients with true node-negative, preventive cervical lymph node dissection is obviously over-treatment, and lower quality of life. Radiotherapy can avoid such surgery.
Objective: To evaluate the effect of radiotherapy on the neck of early oral cancer with poor pathologic factors. This is a randomized, prospective, open, multicenter study. Intervention: Patients receive primary tumor resection followed by radiotherapy. Control: Patients receive primary tumor resection with selective neck dissection. Primary: 2 years neck control rates Secondary: Disease-free survival (1, 2, 3, 5 years) Overall survival (3, 5 years) Quality of life Endpoint definition: 1 year, 2 years, 3 years, 5 years disease-free survival is defined as: patients proportion from the date of surgery completion to 1 year, 2 years, 3 years, 5 years did not find clear evidence of recurrence or metastasis. 3 years, 5 years overall survival is defined as: the proportion of patients who survived from the beginning of the study to the third and fifth year in the total enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
Radiotherapy after primary surgery in the treatment of early oral cancer based on adverse pathological factor
Elective neck dissection after primary surgery in the treatment of early oral cancer based on adverse pathological factor
Shanghai Ninth People's Hospital
Shanghai, China
RECRUITINGNeck control rates
Time frame: 2 years
Disease-free survival
Time frame: 1 year
Disease-free survival
Time frame: 2 years
Disease-free survival
Time frame: 3 years
Disease-free survival
Time frame: 5 years
Overall survival
Time frame: 3 years
Overall survival
Time frame: 5 years
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