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NCT05806073Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 12 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
188 (estimated)
First submitted
21 Feb 2023
Start date
Apr 2023
Primary completion date
Dec 2025
Lead sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
NCT number
NCT05806073

What you commit to

  • Study type: Interventional
  • Planned participants: 188
  • From Apr 2023 to the primary completion date, Dec 2025
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • definite distant metastasis or other malignant tumor;
  • 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;
  • 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);

Other

  • failed to obtain the signed written informed consent;
  • pregnant or lactating women;
  • participated in other clinical trials in the past 30 days;
  • cases that the researcher thinks are not suitable for joining the group.

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.