Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623266
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Neck Observation or Elective Neck Dissection in CT1N0M0 OSCC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neck Observation Versus Selective Neck Dissection in Patients with CT1N0M0 Oral Squamous Cell Carcinoma a Multicenter Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 10-15cm far away from the palpable margins of the lesion Control arm radical resection of the primary lesion with 10-15cm 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None