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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Oral Cancer

Intervention / Treatment
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* Radiation: Radiotherapy
* Procedure: Elective neck dissection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy<br>Primary surgery & Radiotherapy | Radiation: Radiotherapy<br>* Radiotherapy after primary surgery in the treatment of early oral cancer based on adverse pathological factor<br>|
| Active Comparator: Elective neck dissection<br>Primary surgery & Elective neck dissection | Procedure: Elective neck dissection<br>* Elective neck dissection after primary surgery in the treatment of early oral cancer based on adverse pathological factor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck control rates |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 1 year | 
| Disease-free survival |  | 2 years | 
| Disease-free survival |  | 3 years | 
| Disease-free survival |  | 5 years | 
| Overall survival |  | 3 years | 
| Overall survival |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neck dissection, Survival, Early oral cancer, Early oral cavity squamous cancer with node negative neck