Clinical Study Evaluating the Proper Surgical Safety Margin for Early Stage Oral Tongue Cancers

NCT04738786 | Terminated DMC

• 1 other identifier: 2020-08-012
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 4

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 tongue cancer Summary: A current standard primary treatment for oral tongue cancer is a curative surgical resection with/without adjuvant radiation treatments (or chemoradiation). In pathological analysis of surgical specimens, more than 5 mm of non-tumorous tissues from the tumor border is regarded as a safe negative resection margin, according to the NCCN guideline (the National Comprehensive Cancer Network, Dec 10. 2020). To achieve this clear margin, surgeons are apt to use a 1.0 to 1.5 cm safety margin around the gross tumor during surgery, considering 30-50% tumor shrinkage in tissue fixation process. Many previous retrospective data have been reported to suggest the optimal or proper surgical extent for oral tongue cancer. Wider resection can lead to better local control, however, it sacrifices more normal tissue, resulting in the functional deficit of tongue (speech and swallowing), even with reconstruction. Unfortunately up to now, no prospective comparison of a different surgical safety margin for oral tongue cancer have been conducted to draw a more solid conclusion. Particularly in early stage oral tongue cancer (cT1-2N0), some study results have suggested that less than 5 mm resection margin in pathology specimens can be also safe and effective in terms of tumor control. To achieve a well-grounded result about the proper surgical safety margin in early stage (cT1-2N0) oral tongue cancer, we will compare the outcomes of the two (1.5 cm versus 1.0 cm) surgical safety margin in curative resection for cT1-2N0 oral tongue cancer.

Conditions

Tongue Cancer; Tongue Cancer TNM Staging Primary Tumor (T) T1; Tongue Cancer TNM Staging Primary Tumor (T) T2; Surgery; Resection Margin; Squamous Cell Carcinoma

Keywords

Tongue cancer; Surgery; Safety margin

Outcome Measures

Primary Outcomes (1)

• 2 year local control rate

  At 2 years after the completion of treatment, % of local control (or recurrence rate)

  2 year

Secondary Outcomes (3)

• 5 year recurrence free survival

  5 year

• Speech function

  2 year

• Swallowing function

  2 year

Study Arms (2)

Wide surgical safety margin

ACTIVE COMPARATOR

1.5 cm safety margin surgery for cT1-2N0 oral tongue cancer

Procedure: 1.5 cm surgical safety margin for cT1-2N0 oral tongue cancers

Narrow surgical safety margin

ACTIVE COMPARATOR

1.0 cm safety margin surgery for cT1-2N0 oral tongue cancer

Procedure: 1.0 cm surgical safety margin for cT1-2N0 oral tongue cancers

Interventions

1.5 cm surgical safety margin for cT1-2N0 oral tongue cancers PROCEDURE

Surgical resection including 1.5 cm normal tissue around the gross tumors Definition of safety margin: A surgical safety margin is defined as the margin of apparently non-tumorous tissue around a tumor that has been surgically removed (Resected normal-looking tissues from the gross tumor border). The surgical safety margin is applied to all directions of 3-dimensional tumors (mucosal and deep side).

Wide surgical safety margin

1.0 cm surgical safety margin for cT1-2N0 oral tongue cancers PROCEDURE

Surgical resection including 1.0 cm normal tissue around the gross tumors

Narrow surgical safety margin

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead
• Seoul National University Hospital: collaborator
• Asan Medical Center: collaborator
• Ajou University School of Medicine: collaborator
• National Cancer Center, Korea: collaborator
• Inje University: collaborator
• Seoul National University Bundang Hospital: collaborator
• Kangbuk Samsung Hospital: collaborator
• Dong-A University Hospital: collaborator

Study Sites (4)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Ajou university School of Medicine

Suwon, South Korea

Location

Related Publications (1)

• Jang JY, Choi N, Ko YH, Chung MK, Son YI, Baek CH, Baek KH, Jeong HS. Differential Impact of Close Surgical Margin on Local Recurrence According to Primary Tumor Size in Oral Squamous Cell Carcinoma. Ann Surg Oncol. 2017 Jun;24(6):1698-1706. doi: 10.1245/s10434-016-5497-4. Epub 2016 Aug 12.

  PMID: 27519352 BACKGROUND

MeSH Terms

Conditions

Tongue Neoplasms; Margins of Excision; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Study Officials

• Han-Sin Jeong, MD PhD

  Head and Neck Cancer Center, Samsung Medical Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Head and Neck Cancer Center

Model Details: A prospective multicenter randomized non-inferiority clinical trial, comparing two groups; 1.5 cm surgical safety margin versus 1.0 cm surgical safety margin in curative resection for cT1-2N0 oral tongue cancer

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 4, 2021
• Study Start: January 18, 2021
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)