The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor
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- STATUS
- Recruiting
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- End date
- Jul 21, 2025
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- participants needed
- 270
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- sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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.
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.
Details
| Condition | Oral Cancer |
|---|---|
| Treatment | Radiotherapy, elective neck dissection |
| Clinical Study Identifier | NCT03017053 |
| Sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
| Last Modified on | 24 February 2022 |
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