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

Jinsong Hou

Status

Enrolling

Conditions

Carcinoma, Squamous Cell

Treatments

Procedure: Resection for primary lesion only

Procedure: Resection for primary lesion and cervical lymph node dissection

Study type

Interventional

Funder types

Other

Identifiers

NCT02743832

HouJ-2015018

Details and patient eligibility

About

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.

Full 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.

Enrollment

524 estimated patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

524 participants in 4 patient groups

High-level tumor budding group with CLND

Experimental group

Description:

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.

Treatment:

Procedure: Resection for primary lesion and cervical lymph node dissection

High-level tumor budding group without CLND

Experimental group

Description:

Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level.

Treatment:

Procedure: Resection for primary lesion only

Low-level tumor budding group with CLND

Experimental group

Description:

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.

Treatment:

Procedure: Resection for primary lesion and cervical lymph node dissection

Low-level tumor budding group without CLND

Experimental group

Description:

Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level.

Treatment:

Procedure: Resection for primary lesion only