The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor

  • End date
    Jul 21, 2025
  • participants needed
  • sponsor
    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Updated on 24 February 2022
oral cancer
neck dissection


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.


2 years neck control rates


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.

Condition Oral Cancer
Treatment Radiotherapy, elective neck dissection
Clinical Study IdentifierNCT03017053
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Last Modified on24 February 2022


Yes No Not Sure

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document
Age 18 and 75 years
Clinical/ Histological/ cytological/ Imaging examination proven Oral/Oropharynx Squamous-cell carcinoma (Tongue, buccal mucosa, mouth floor, hard palate, Molar area), the depth of invasion > 4mm in preoperative assessment
In line with clinical stage I / II stage (T1-2 N0 M0; AJCC 2010) and receiving surgical resection
KPS 70
Normal bone marrow reserve function and normal liver, kidney function
Expected survival period 6 months

Exclusion Criteria

Inability to provide an informed consent
Evidence of oral distant metastasis or other malignancies
The patient has received prior surgery for primary tumor or lymph node ( except for biopsy )
Prior radiotherapy for primary tumor
The patient has previously received anti-tumor biological targeted therapy
The patient has received chemotherapy or immunotherapy for primary tumors
Prior malignancy within the previous 5 years (except for cured skin basal cell carcinoma or cervical carcinoma in situ)
With 3-4 grad Allergy to any drug in the treatment
Peripheral neuropathy> 1 grade
Any unstable systematic disease (including active infection, uncontrolled high blood pressure, unstable angina, onset of angina within the last 3 months, congestive heart failure, myocardial infarction within the previous 12 months, severe arrhythmia needing drug treatment, liver, kidney or metabolic disease)
HIV positive
Chronic diseases requiring immune agents or hormone therapy
Pregnant or lactating women
Drug/alcohol abuse, psychological or spiritual illness that may interfere compliance to the study
Patients with epilepsy requiring medications (such as steroids or antiepileptic drugs)
The patient has participated in other experimental therapy studies within 30 days
Researchers believe that the situation is unsuitable for participation in the group
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