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

NCT05806073 | Not Yet Recruiting

• 1 other identifier: SH9H-2022-T349-2
• Study Type: interventional
• Target: 188
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cervical lymph node metastasis is the most important prognostic factor of oral squamous cell carcinoma (OSCC). Therapeutic neck dissection (I-V region) has always been regarded as the standard scheme of neck surgery for patients with cN+ OSCC and however, it has brought obvious side effects, which seriously affects the postoperative quality of life of patients. In addition, excessive neck lymph node dissection will also affect the local immune function of patients to some extent and reduce the body's response to immunotherapy. Lymph node metastasis of primary oral squamous cell carcinoma follows certain rules. Most of the metastatic areas are I-II, and low-level metastasis is very rare. Therefore, more than 90% of patients with cN+ oral squamous cell carcinoma who have undergone Therapeutic neck dissection may have suffered from "excessive dissection of area of IV and V". Both the long-term clinical experience of surgeons and a large number of recent retrospective studies show that elective neck dissection (I-III region) is safe enough for patients with oral squamous cell carcinoma of cN1 and part of cN2.There is clearly a need therefore for a large randomized trial that will resolve the issue either way once and for all.

Conditions

Oral Squamous Cell Carcinoma; Neck Dissection

Outcome Measures

Primary Outcomes (1)

• Recurrence rate of neck

  From date of randomization until the date of metastasis of ipsilateral or contralateral cervical lymph nodes

  up to 2 year

Secondary Outcomes (1)

• Overall survival

  up to 2 year

Study Arms (2)

Elective neck dissection

EXPERIMENTAL

patient underwent elective neck dissection(level I-III) as initial treatment, along with the excision of the primary tumor

Procedure: Elective neck dissection

Therapeutic neck dissection

EXPERIMENTAL

Patient underwent therapeutic neck dissection(level I-V) as initial treatment, along with the excision of the primary tumor

Procedure: Therapeutic neck dissection

Interventions

Elective neck dissection PROCEDURE

patient underwent elective neck dissection(level I-III) as initial treatment, along with the excision of the primary tumor

Elective neck dissection

Therapeutic neck dissection PROCEDURE

patient underwent Therapeutic neck dissection(level I-V) as initial treatment, along with the excision of the primary tumor

Therapeutic neck dissection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• No history of chemotherapy, radiotherapy or targeted therapy,for any reason before
• No history of a prior malignancy in head and neck region
• No history of a prior malignancy outside head and neck region in the preceding 5 years
• Eastern Cooperative Oncology Group Performance score (ECOG PS) is 0 or 1;
• Participants will be reliable for follow-up
• Understanding the protocol and is able to give informed consent

You may not qualify if:

• failed to obtain the signed written informed consent;
• definite distant metastasis or other malignant tumor;
• Previous surgical operations for primary tumors or lymph nodes in the head and neck (except biopsy);
• previously received radiotherapy for primary tumors or lymph nodes;
• previously received anti-tumor biological targeted therapy;
• Chemotherapy or immunotherapy has been applied to the primary tumor in the past;
• Patients with any malignant tumor in the past 5 years (except the cured basal cell carcinoma of the skin or cervical carcinoma in situ)；
• 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);
• known human immunodeficiency virus (HIV) infection;
• chronic diseases requiring immune preparations or hormone treatment;
• pregnant or lactating women;
• drug/alcohol abuse, or suffering from psychological or mental diseases that may interfere with research compliance;
• Epilepsy patients who need medical treatment (such as steroids or antiepileptic drugs);
• participated in other clinical trials in the past 30 days;
• cases that the researcher thinks are not suitable for joining the group.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Hong Zhen

CONTACT

+86-（021）23271699; hannannan111@126.com

Min Ruan

CONTACT

+86-18717893527; doctorruanmin@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: April 10, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 12, 2023

Record last verified: 2023-03