Carcinoma, Squamous Cell
Conditions
Keywords
Oral squamous cell carcinoma, Tumor budding, Cervical lymph node dissection
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.
Interventions
PROCEDUREResection for primary lesion and cervical lymph node dissection
Resection for primary lesion and cervical lymph node dissection are performed in the early-stage oral squamous cell carcinoma.
PROCEDUREResection for primary lesion only
Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma.
Sponsors
Jinsong Hou
First Affiliated Hospital, Sun Yat-Sen University
Second Affiliated Hospital, Sun Yat-Sen University
Hospital of Stomatology, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Han race; 2. Oral squamous cell carcinoma is confirmed by pathology; 3. The section of oral squamous cell carcinoma including primary two-thirds prior to the tongue, buccal mucosa， gingiva， mouth floor， hard palate mucosa; 4. The primary lesion is no more than 4cm; 5. Do not find cervical lymph node metastases and distant metastasis in the clinical examination including physical examination and MRI; 6. Patients and families agree to participate in the study; 7. Patients do not have cognitive disorders.
Exclusion criteria
1. Do not meet the inclusion criteria; 2. The primary lesion is more than 4cm or invade adjacent tissues; 3. Do not review on schedule; 4. Patients receive not only surgical procedures, but other antineoplastic treatment; 5. There are serious adverse events after operation; 6. Patients quit the study voluntarily; 7. Patients quit the study because of physical condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Five-year survival rate | After the first year, review every three months at a time；The next four years, review every six months at a time. | The time from the first operation to death was recorded |
| Disease free survival | After the first year, review every three months at a time；The next four years, review every six months at a time. | The time from the start of surgery to the discovery of the first cervical lymphatic metastases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate | After the first year, review every three months at a time；The next four years, review every six months at a time. | To investigate the local recurrence rate and the recurrence rate of cervical lymphatic metastasis. |
| Evaluation of quality of life | After the first year, review every three months at a time；The next four years, review every six months at a time. | Complete the University of Washington Quality of Life Form (UW-QOL) To understand the quality of life of patients after surgery. |
Countries
China
Contacts
CONTACTJinsong Hou, PhD
CONTACTCheng Wang, PhD
STUDY_DIRECTORJinsong Hou, PhD
Guanghua School of Stomatology, Hospital of Stomatolagy Sun Yat-sen University
Outcome results
None listed