Elective vs Therapeutic Neck Dissection in Treatment of Patients With Clinical T1/2N1M0 Oral Squamous Cell Carcinoma

Launched by SHANGHAI NINTH PEOPLE'S HOSPITAL AFFILIATED TO SHANGHAI JIAO TONG UNIVERSITY · Mar 28, 2023

Keywords

ClinConnect Summary

This clinical trial is examining the effectiveness of two different types of neck surgery for patients with early-stage oral squamous cell carcinoma (OSCC), which is a type of cancer found in the mouth. One approach is called "therapeutic neck dissection," where a larger area of the neck is surgically removed to check for cancer spread. The other approach is "elective neck dissection," which targets a smaller area. The goal is to see if the smaller surgery is just as safe and effective, but with fewer side effects, improving patients' quality of life after surgery.

To be eligible for this trial, participants must be adults aged between 18 and 75 who have a specific type of early-stage OSCC in areas of the mouth like the tongue or gums. They should not have any prior cancer treatments or other serious health issues that could interfere with the study. If you join this trial, you'll undergo one of the two types of surgery and will be closely monitored afterward to assess your recovery and overall health. It's important to know that this trial is not yet recruiting participants, but it aims to provide valuable insights into the best treatment approach for patients with this type of cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically proven T1 or T2 N1 M0( AJCC 8th) squamous call carcinoma of tongue(except base of the tongue ), buccal mucosa, upper and lower gums, hard palate and floor of mouth;
• • 2. No history of chemotherapy, radiotherapy or targeted therapy,for any reason before
• • 3. No history of a prior malignancy in head and neck region
• • 4. No history of a prior malignancy outside head and neck region in the preceding 5 years
• • 5. Eastern Cooperative Oncology Group Performance score (ECOG PS) is 0 or 1;
• • 6. Participants will be reliable for follow-up
• • 7. Understanding the protocol and is able to give informed consent
• Exclusion Criteria:
• • 1. failed to obtain the signed written informed consent;
• • 2. definite distant metastasis or other malignant tumor;
• • 3. Previous surgical operations for primary tumors or lymph nodes in the head and neck (except biopsy);
• • 4. previously received radiotherapy for primary tumors or lymph nodes;
• • 5. previously received anti-tumor biological targeted therapy;
• • 6. Chemotherapy or immunotherapy has been applied to the primary tumor in the past;
• • 7. Patients with any malignant tumor in the past 5 years (except the cured basal cell carcinoma of the skin or cervical carcinoma in situ)；
• • 8. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that started in the last 3 months, congestive heart failure, myocardial infarction that occurred in the first 12 months, serious arrhythmia requiring medical treatment, liver, kidney or metabolic diseases);
• • 9. known human immunodeficiency virus (HIV) infection;
• • 10. chronic diseases requiring immune preparations or hormone treatment;
• • 11. pregnant or lactating women;
• • 12. drug/alcohol abuse, or suffering from psychological or mental diseases that may interfere with research compliance;
• • 13. Epilepsy patients who need medical treatment (such as steroids or antiepileptic drugs);
• • 14. participated in other clinical trials in the past 30 days;
• • 15. cases that the researcher thinks are not suitable for joining the group.