Neck Observation Versus Selective Neck Dissection in Patients with CT1N0M0 Oral Squamous Cell Carcinoma: a Multicenter Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Huashan Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Lai-ping Zhong, MD, PhD
zhonglp@hotmail.com
+862152888915
Backup
Liang Gu, MD
guliang@hotmail.com
+862152889999
Time Frame
Start Date: 2024-09-26
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 300
Treatments
Placebo_comparator: Experimental arm
The patients in the experimental arm will receive 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. Ultrasonography, CT scan, and/or MRI examination will be used to detect lesions.
Active_comparator: Control arm
The patients in the control arm will receive radical resection of the primary lesion with the safety margins of the primary lesion are 1.0-1.5cm far away from the palpable margins of the lesion, they will also receive simultaneous elective neck dissection. Ultrasonography, CT scan, and/or MRI examination will be used to detect lesions.
Related Therapeutic Areas
Sponsors
Leads: Huashan Hospital