Neck Observation or Elective Neck Dissection in CT1N0M0 OSCC

Last updated: November 12, 2024
Sponsor: Huashan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasm Metastasis

Oral Cancer

Head And Neck Cancer

Treatment

Neck management

Clinical Study ID

NCT06623266
Acromion
  • Ages 18-75
  • All Genders

Study Summary

To evaluate the clinical outcomes of 2-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life in the patients with cT1N0M0 oral squamous cell carcinoma, who receive primary lesion resection combined with elective neck dissection or primary lesion resection only.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Tumor site: tongue, gingiva, buccal mucosa, floor of mouth, hard palate, retromolareara

  • Clinical stage is cT1N0M0 (AJCC 8th edition)

  • Pathological diagnosis of squamous cell carcinoma

  • Sign the informed consent form

Exclusion

Exclusion Criteria:

  • More than 2 lesions found in the oral cavity

  • Known history of malignant tumor within five years (unless the patient has undergonecurative treatment and there is no disease recurrence within 5 years since the startof treatment)

  • History of unilateral or bilateral neck dissection in the past

  • History of previous head and neck radiotherapy

  • Pregnant or lactating women

  • Severe, uncontrolled infection or known HIV infection; or previous organtransplantation, stem cell or bone marrow transplantation

  • Participated in other clinical studies within 30 days before enrollment

  • Other circumstances that the researcher considers unsuitable for participation inthe study

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Neck management
Phase:
Study Start date:
September 26, 2024
Estimated Completion Date:
September 30, 2028

Study Description

For the patients with cT1N0M0 oral squamous cell carcinoma (OSCC), surgical resection of primary lesion is the preferred treatment. However, there are still debates on the neck management, some surgeons suggest elective neck dissection (END), and some surgeons suggest neck observation (NOB). The advantage of elective neck dissection is to clear the potential occult neck lymph node metastasis (about 15%), which could not be detected by clinical examination and imaging examination, and the disadvantage of END is to cause neck deformity, large scars, stiff neck and shoulders, difficulty in raising shoulders, and increase medical costs. The disadvantage of NOB is the risk of lymph node metastasis and disease progression. However, recent retrospective studies show that END has no potential benefit in improving survival in cT1N0M0 patients. The aim of the present trial is to compare the clinical outcomes between the cT1N0M0 OSCC patients, who receive primary lesion resection combined with elective neck dissection or primary lesion resection only, on the aspects of 2-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life. A total number of 300 patients will be recruited, including 150 patients in the experimental arm and 150 patients in the control arm. Experimental arm: radical resection of the primary lesion only, with neck observation, the safety margins of the primary lesion are 1.0-1.5cm far away from the palpable margins of the lesion. Control arm: radical resection of the primary lesion with 1.0-1.5cm safety margins, and elective neck dissection. A complete medical history will be obtained and tumor assessment will be performed at baseline. Patients will be followed-up by every three months in the first 2 years, every six months in the next 3-5 years, and once a year thereafter until death or data censoring. Two-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life will be collected and analyzed.

Connect with a study center

  • Huashan Hospital, Fudan University

    Shanghai, 200040
    China

    Active - Recruiting

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