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

NCT ID: NCT04738786

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-18
• Study Completion Date: 2025-01-31

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.

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) should be provided to the subjects in the order of the date of surgery.

Surgical Procedure

• The study includes T1-2N0 oral tongue cancer patients. For the management of the primary lesion, wide resection with 1.0- or 1.5-cm surgical safety margin should be performed according to the results of study allocation.
• Neck management can be resection of primary tumor without neck dissection, with ipsilateral or bilateral neck dissection (guided by tumor location) or with sentinel lymph node biopsy, according to the NCCN guideline (version 1.2021).

Evaluation of the surgical safety margin

• The surgical safety margin should be meticulously evaluated in the pathology specimens in all directions.
• The surgical margins less than 0.3 or 0.5 cm in final pathology results are considered as the close surgical margin.

Adjuvant Treatment

• The adjuvant treatments either radiotherapy or chemoradiotherapy are conducted if indicated following the NCCN guideline.
• The follow-up after completion of the definitive treatment are made following the NCCN guideline.

Efficacy evaluation

• The primary outcomes are determined with 2-year local control rates after the completion of the curative treatments.
• The secondary outcomes are determined with the 5-year disease-free survival rates and speech/articulation functional analysis.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Wide surgical safety margin

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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).

Narrow surgical safety margin

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

Surgical resection including 1.0 cm normal tissue around the gross tumors

Interventions

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).

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: collaborator

Ajou University School of Medicine

OTHER

Sponsor Role: collaborator

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: collaborator

Inje University

OTHER

Sponsor Role: collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role: collaborator

Kangbuk Samsung Hospital

OTHER

Sponsor Role: collaborator

Dong-A University Hospital

OTHER

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Han-Sin Jeong

Director of Head and Neck Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Han-Sin Jeong, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Head and Neck Cancer Center, Samsung Medical Center, Korea

Locations

Samsung Medical Center

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Ajou university School of Medicine

Suwon, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 27519352 (View on PubMed)

Other Identifiers

2020-08-012

Identifier Type: -

Identifier Source: org_study_id