Survival Benefit of Elective Neck Dissection in T1,2N0M0 Oral Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
Controversy over surgical treatment of clinically negative neck in early stage oral squamous cell carcinoma revolves around the uncertainty of its impact on patient prognosis. The efficacy of elective neck dissection on prognosis in T1, 2 N0M0 patients continues to be the subject of clinical debate. Currently the clinically negative patients are treated by one of the two main policies: one is elective neck dissection; the other is watchful waiting. The objective of this multi-institutional prospective randomized controlled study is to evaluate the survival benefit of elective neck dissection on the prognosis of T1, 2 N0M0 patients with carcinoma of oral cavity. The enrolled patients with T1, 2 N0M0 oral cancer will be randomized into two groups: elective neck dissection versus watch and wait. The survival rate and the recurrence rate between two groups will be compared. The result of the study will give surgeons evidence-based instructions for the management of clinically negative neck in patients with cancer of oral cavity.

Detailed Description
-----------------
There are controversies on the benefits of elective neck dissection (END) for clinically negative neck in early stage oral squamous cell carcinoma. The aim of this study is to determine the need for a randomized controlled trial in order to evaluate the survival benefit of elective neck dissection on the prognosis of T1, 2 N0M0 patients with carcinoma of oral cavity. We initiate this multi-institutional study, expecting 448 primary oral cancer patients to be enrolled. And we are going to randomly divide these patients into two groups: END and watch and wait. The END group will undergo one stage surgery of END and primary tumor excision, and the watch and waitgroup will be treated with primary tumor excision transorally as initial treatment, with rigorous postoperation consultation. All patients will be followed up with at least 5 years after initial treatment, and the survival rate and the recurrence rate between groups will be compared.

Official Title
-----------------
Survival Benefit of Elective Neck Dissection for Patients With T1,2N0M0 Oral Squamous Cell Carcinoma-A Prospective Multicenter Randomized Controlled Study

Conditions
-----------------
Oral Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Procedure: elective neck dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age:20 to 70 years old, both male and female Histologically proven T1 or T2 N0 M0 (clinical) squamous cell carcinoma of the oral tongue, buccal mucosa, gingiva, floor of mouth, and hard palate The maximum diameter of the primary tumor is less than 4cm Clinical nodal staging has been confirmed negative via both clinical examination and imaging (MRI or lateral and central neck ultrasound) With at least 1-year's expected survival time Willing to join the protocol and is able to give written informed consent Exclusion Criteria: Patient with severe cardiac insufficiency, hepatic insufficiency, renal insufficiency, of systemic infection diseases The patient is pregnant or lactating Patients with a history of surgical treatment, radiotherapy, chemotherapy, biotherapy and targeted therapy, et al, before participating in the study Patient is currently participating in another investigational drug study

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: elective neck dissection<br>patient underwent elective neck dissection as initial treatment, along with the excision of the primary tumor | Procedure: elective neck dissection<br>* patient underwent elective neck dissection as initial treatment, along with the excision of the primary tumor<br>* Other names: superior omohyoid neck dissection, SOHND;|
| No Intervention: wait and see<br>patient underwent primary tumor excision transorally as initial treatment, and without a cervical intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether elective neck dissection (END) has equal or higher survival rate to the wait and watch policy | The 5-year's survival and the disease free survival of the two group of patients are being measured and compared with one and other, so the survival benefit of the two policy is evaluated. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does END have the equal or lower recurrence rate to the wait and watch policy | The recurrence includes recurrence of the primary tumor and the neck, and it's measured by clinical examination, MRI examination and ultrasonic inspection. | 5 years | 
| quality of life | The quality of life of patients after surgery is measured by UW-QOL. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral squamous cell carcinoma, elective neck dissection, watchful waiting, survival benefit, recurrence rate