Neck Observation or Elective Neck Dissection in CT1N0M0 OSCC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHuashan Hospital
About this trial
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
Qualifiers
Tumor site: tongue, gingiva, buccal mucosa, floor of mouth, hard palate, retromolar eara
Clinical stage is cT1N0M0 (AJCC 8th edition)
Pathological diagnosis of squamous cell carcinoma
Sign the informed consent form
Disqualifiers
More than 2 lesions found in the oral cavity
Known history of malignant tumor within five years (unless the patient has undergone curative treatment and there is no disease recurrence within 5 years since the start of treatment)
History of unilateral or bilateral neck dissection in the past
History of previous head and neck radiotherapy
Trial design
Treatments tested in this trial
- Neck management
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov