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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 20 Years - 80 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04738786
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Samsung Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Han-Sin Jeong, MD PhD
Principal Investigator Affiliation Head and Neck Cancer Center, Samsung Medical Center, Korea
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Korea, Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

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.

Arms & Interventions

Arms

Active Comparator: Wide surgical safety margin

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

Active Comparator: Narrow surgical safety margin

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

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

Contact a Trial Team

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International Sites

Samsung Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center

Seoul, , 135-710

Site Contact

Han-Sin Jeong, MD, PhD

[email protected]

82-2-3410-3577

Asan Medical Center, Seoul, Korea, Republic of

Status

Not yet recruiting

Address

Asan Medical Center

Seoul, ,

Site Contact

Youngho Chung

[email protected]

82-2-3410-3579

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Not yet recruiting

Address

Seoul National University Hospital

Seoul, ,

Site Contact

Eunjae Chung

[email protected]

82-2-3410-3579

Ajou university School of Medicine, Suwon, Korea, Republic of

Status

Not yet recruiting

Address

Ajou university School of Medicine

Suwon, ,

Site Contact

Jeon Yeob Jang

[email protected]

82-2-3410-3579

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