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
This trial does not accept healthy volunteersQualifiers
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
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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
Design model
Parallel
Treatments tested in this trial
Neck management
Procedure/SurgeryIn the experimental arm: the neck management is neck observation, simultaneous elective neck dissection is not performed during the surgical resection of primary lesion. The patients will be followed up every two months for at least two years, focusing on the lymph node metastasis and local recurrence. Ultrasonography, CT scan, and/or MRI will be used to detect lesions. In the control arm: the neck management is elective neck dissection. Simultaneous elective neck dissection is performed during the surgical resection of primary lesion. The patients will be followed up every two months for at least two years, focusing on the lymph node metastasis and local recurrence. Ultrasonography, CT scan, and/or MRI will be used to detect lesions.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Experimental armPlacebo comparator 1 intervention
Group B: Control armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of 2-year lymph node metastasis
Lymph node metastasis is confirmed by pathological examinations, using fine needle aspiration cytology or biopsy. The rate of 2-year lymph node metastasis rate is reported as the percentage of patients who are free from lymph node metastasis for 2 years from the date of randomization.
Time frame
2 yearsSecondary outcomes
1
Rate of 2-year disease free survival
Disease free survival is calculated from the date of randomization to local recurrence, regional recurrence, distant metastasis or death. The rate of 2-year disease free survival is reported as the percentage of patients who are disease free survival for 2 years from the date of randomization.
Time frame
2 years2
Rate of 2-year overall survival
Overall survival is calculated from the date of randomization to death. The rate of 2-year overall survival is reported as the percentage of patients who are overall survival for 2 years from the date of randomization.
Time frame
2 years3
Health-related quality of life
Health-related quality of life will be measured and scored using the Chinese version of the University of Washington Quality of Life (UW-QOL) scale. Each score ranges from 0 to 100 points. The lower the score, the worse the functional perception.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov