The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor

Oral Cancer Clinical Trial

Official title: The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lip Neoplasms
• Mouth Neoplasms
• Oral Cancer

• NCT number: NCT03017053
• Study type: Interventional
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Chenping ZHANG, Ph.D
• Phone: +86-21-63136856
• Email: zhang.chenping@hotmail.com
• Status: Recruiting
• Phase: Phase 4
• Start date: July 2016
• Completion date: July 2025