Neoplasms

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Carcinoma

Carcinoma, Squamous Cell

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Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

patient underwent elective neck dissection as initial treatment, along with the excision of the primary tumor

patient underwent primary tumor excision transorally as initial treatment, and without a cervical intervention

elective neck dissection

Guiqing Liao, MD, DDS

Guiqing Liao, MD,DDS

Yuantao Hao, PhD

Yuxiong Su, MD,DDS

Zhuming Guo, MD

Chongjin Feng, PhD

Chongjin Feng, MD,DDS

Jinsong Li, PhD

Jinsong Li, MD,DDS

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.

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 wait"group 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.

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

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

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.

The recurrence includes recurrence of the primary tumor and the neck, and it's measured by clinical examination, MRI examination and ultrasonic inspection.

The quality of life of patients after surgery is measured by UW-QOL.

First Affiliated Hospital, Sun Yat-Sen University

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Sun Yat-sen University

Guanghua School of Stomatology, Hospital of Stomatology

patient underwent elective neck dissection(level I-III) as initial treatment, along with the excision of the primary tumor

Patient underwent therapeutic neck dissection(level I-V) as initial treatment, along with the excision of the primary tumor

Elective neck dissection

patient underwent Therapeutic neck dissection(level I-V) as initial treatment, along with the excision of the primary tumor

Therapeutic neck dissection

Hong Zhen

Min Ruan

Cervical lymph node metastasis is the most important prognostic factor of oral squamous cell carcinoma (OSCC). Therapeutic neck dissection (I-V region) has always been regarded as the standard scheme of neck surgery for patients with cN+ OSCC and however, it has brought obvious side effects, which seriously affects the postoperative quality of life of patients. In addition, excessive neck lymph node dissection will also affect the local immune function of patients to some extent and reduce the body's response to immunotherapy. Lymph node metastasis of primary oral squamous cell carcinoma follows certain rules. Most of the metastatic areas are I-II, and low-level metastasis is very rare. Therefore, more than 90% of patients with cN+ oral squamous cell carcinoma who have undergone Therapeutic neck dissection may have suffered from "excessive dissection of area of IV and V".

Both the long-term clinical experience of surgeons and a large number of recent retrospective studies show that elective neck dissection (I-III region) is safe enough for patients with oral squamous cell carcinoma of cN1 and part of cN2.There is clearly a need therefore for a large randomized trial that will resolve the issue either way once and for all.

There are controversies on the benefits of therapeutic neck dissection (I-V region) for clinically T1-2N1M0 oral squamous cell carcinoma(cT1-2N1M0). The aim of this study is to determine the need for a randomized controlled trial in order to evaluate the safety of elective neck dissection (I-III region) for patients of cT1-2N1M0. We initiate this study, expecting 188 primary oral cancer patients to be enrolled. And we are going to randomly divide these patients into two groups: "elective neck dissection (END)" and "therapeutic neck dissection (TND)". The END group will undergo one stage surgery of END and primary tumor excision, and the TND group will be treated with one stage surgery of TND and primary tumor excision. All patients will be followed up with at least 2 years after initial treatment, and the neck recurrence rate (primary outcome measures), postoperative complication rate, quality of life and survival between groups will be compared.

Elective vs Therapeutic Neck Dissection in Treatment of Patients With Clinical T1/2N1M0 Oral Squamous Cell Carcinoma

From date of randomization until the date of metastasis of ipsilateral or contralateral cervical lymph nodes

From date of randomization until the date of death from any cause

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Mouth and Tooth Diseases

Mouth Neoplasms

Lip Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Primary surgery \& Elective neck dissection

Radiotherapy after primary surgery in the treatment of early oral cancer based on adverse pathological factor

Radiotherapy

Elective neck dissection after primary surgery in the treatment of early oral cancer based on adverse pathological factor

Chenping ZHANG, Ph.D

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization
Survival Benefit of Elective Neck Dissection in T1,2N0M0 Oral Squamous Cell Carcinoma	NCT01334320	Oral Squamous C...	elective neck d...	20 Years - 70 Years	Sun Yat-sen University
Elective vs Therapeutic Neck Dissection in Treatment of Patients With Clinical T1/2N1M0 Oral Squamous Cell Carcinoma	NCT05806073	Oral Squamous C... Neck Dissection	Elective neck d... Therapeutic nec...	18 Years - 75 Years	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor	NCT03017053	Oral Cancer	Radiotherapy Elective neck d...	18 Years - 75 Years	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Spots Global Cancer Trial Database for elective neck dissection