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

Not Applicable

Recruiting

• Conditions: Carcinoma, Squamous Cell
• Interventions: Procedure: Resection for primary lesion only; Procedure: Resection for primary lesion and cervical lymph node dissection

• Registration Number: NCT02743832
• Lead Sponsor: Jinsong Hou

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.

Study Timeline

• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-19
• Status Verified: 2022-09
• Study Start: 2022-09-04
• Last Update Submitted: 2022-09-04
• Last Update Posted: 2022-09-07
• Primary Completion: 2025-05-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 524

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-level tumor budding group without CLND	Resection for primary lesion only	Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level.
High-level tumor budding group without CLND	Resection for primary lesion only	Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level.
High-level tumor budding group with CLND	Resection for primary lesion and cervical lymph node dissection	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.
Low-level tumor budding group with CLND	Resection for primary lesion and cervical lymph node dissection	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.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Guanghua School of Stomatolagy, Hospital of Stomatology Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China