A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma.

Detailed Description
-----------------
Oral squamous cell carcinoma is the most common malignant tumor of oral and maxillofacial region, and prone to early cervical lymph node metastases. Lymphatic spread is associated with increased risk of loco-regional recurrence, therefore, the identification of lymph node metastases preoperatively is very important for the optimal surgical therapy. Recently, cervical lymph node dissection(CLND) is performed in the presence of oral squamous cell carcinoma. However, whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma is still controversial. CLND will represent over-treatment in some case of early-stage oral squamous cell carcinoma. Therefore, How to accurately predict whether a patient should be performed CLND is important. Our previous study show that tumor budding is closely related to lymphatic spread in the oral squamous cell carcinoma. The purpose of this study is to find that whether the tumor budding guide the individualized surgical planning of early-stage oral squamous cell carcinoma.

Official Title
-----------------
A Randomized，Multicenter，Prospectie，Controlled Clinical Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.

Conditions
-----------------
Carcinoma, Squamous Cell

Intervention / Treatment
-----------------
* Procedure: Resection for primary lesion and cervical lymph node dissection
* Procedure: Resection for primary lesion only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Han race; Oral squamous cell carcinoma is confirmed by pathology; The section of oral squamous cell carcinoma including primary two-thirds prior to the tongue, buccal mucosa， gingiva， mouth floor， hard palate mucosa; The primary lesion is no more than 4cm; Do not find cervical lymph node metastases and distant metastasis in the clinical examination including physical examination and MRI; Patients and families agree to participate in the study; Patients do not have cognitive disorders. Exclusion Criteria: Do not meet the inclusion criteria; The primary lesion is more than 4cm or invade adjacent tissues; Do not review on schedule; Patients receive not only surgical procedures, but other antineoplastic treatment; There are serious adverse events after operation; Patients quit the study voluntarily; Patients quit the study because of physical condition.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-level tumor budding group with CLND<br>Resection for primary lesion and cervical lymph node dissection (CLND) are performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level. | Procedure: Resection for primary lesion and cervical lymph node dissection<br>* Resection for primary lesion and cervical lymph node dissection are performed in the early-stage oral squamous cell carcinoma.<br>|
| Experimental: High-level tumor budding group without CLND<br>Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level. | Procedure: Resection for primary lesion only<br>* Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma.<br>|
| Experimental: Low-level tumor budding group with CLND<br>Resection for primary lesion and cervical lymph node dissection (CLND) are performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level. | Procedure: Resection for primary lesion and cervical lymph node dissection<br>* Resection for primary lesion and cervical lymph node dissection are performed in the early-stage oral squamous cell carcinoma.<br>|
| Experimental: Low-level tumor budding group without CLND<br>Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level. | Procedure: Resection for primary lesion only<br>* Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Five-year survival rate | The time from the first operation to death was recorded | After the first year, review every three months at a time；The next four years, review every six months at a time. | 
| Disease free survival | The time from the start of surgery to the discovery of the first cervical lymphatic metastases | After the first year, review every three months at a time；The next four years, review every six months at a time. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | To investigate the local recurrence rate and the recurrence rate of cervical lymphatic metastasis. | After the first year, review every three months at a time；The next four years, review every six months at a time. | 
| Evaluation of quality of life | Complete the University of Washington Quality of Life Form (UW-QOL) To understand the quality of life of patients after surgery. | After the first year, review every three months at a time；The next four years, review every six months at a time. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral squamous cell carcinoma, Tumor budding, Cervical lymph node dissection