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

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

Interventions

PROCEDURE

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

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).

PROCEDURE

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

Surgical resection including 1.0 cm normal tissue around the gross tumors

Sponsors & Collaborators

• Seoul National University Hospital

  collaborator OTHER

• Asan Medical Center

  collaborator OTHER

• Ajou University School of Medicine

  collaborator OTHER

• National Cancer Center, Korea

  collaborator OTHER_GOV

• Inje University

  collaborator OTHER

• Seoul National University Bundang Hospital

  collaborator OTHER

• Kangbuk Samsung Hospital

  collaborator OTHER

• Dong-A University Hospital

  collaborator OTHER

• Samsung Medical Center

  lead OTHER

Principal Investigators

• Han-Sin Jeong, MD PhD · Head and Neck Cancer Center, Samsung Medical Center, Korea

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-18

Primary Completion

2025-01-31

Completion

2025-01-31

Countries

• South Korea

Study Locations