Status:
TERMINATED
Clinical Study Evaluating the Proper Surgical Safety Margin for Early Stage Oral Tongue Cancers
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Seoul National University Hospital
Asan Medical Center
Conditions:
Tongue Cancer
Tongue Cancer TNM Staging Primary Tumor (T) T1
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
A prospective multicenter randomized non-inferiority clinical trial, to evaluate the efficacy and safety of 1.0 cm-safety margin surgery, compared with 1.5 cm safety margin surgery for cT1-2N0 oral to...
Detailed Description
Randomization * The randomized allocation table was made by stratified block randomization methods with 1:1 ratio according to each participating surgeon and tumor stage. * Baseline number (BN) shoul...
Eligibility Criteria
Inclusion
- Pathologically proven oral tongue squamous cell carcinoma
- Stage cT1-2N0M0 tumors
- Treatment-naïve tumor
- American Society of Anesthesiologists (ASA) physical status classification 1-3.
- Patients who give a written informed consent voluntarily.
Exclusion
- cT3-4 or N(+) tumors
- Recurrent tumors or salvage surgery
- Patients who have had a previous head and neck surgery and radiation treatment.
- Patients who have other head and neck cancer, within the last 5 years.
Key Trial Info
Start Date :
January 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04738786
Start Date
January 18 2021
End Date
January 31 2025
Last Update
May 18 2025
Active Locations (4)
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1
Samsung Medical Center
Seoul, South Korea, 135-710
2
Asan Medical Center
Seoul, South Korea
3
Seoul National University Hospital
Seoul, South Korea
4
Ajou university School of Medicine
Suwon, South Korea