Tongue CancerNCT04738786
Clinical Study Evaluating the Proper Surgical Safety Margin for Early Stage Oral Tongue Cancers
A study testing 1.5 cm surgical safety margin for cT1-2N0 oral tongue cancers and 1.0 cm surgical safety margin for cT1-2N0 oral tongue cancers in people with Tongue Cancer and Tongue Cancer TNM Staging Primary Tumor (T) T1, run by Samsung Medical Center at 4 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Tongue Cancer, Tongue Cancer TNM Staging Primary Tumor (T) T1, Tongue Cancer TNM Staging Primary Tumor (T) T2
- What is being tested?
- 1.5 cm surgical safety margin for cT1-2N0 oral tongue cancers and 1.0 cm surgical safety margin for cT1-2N0 oral tongue cancers
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 18 Jan 2021to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
South Korea4 sites
Samsung Medical Center
Seoul, 135-710
Asan Medical Center
Seoul
Seoul National University Hospital
Seoul
Ajou university School of Medicine
Suwon
About this study
Official title: Clinical Study Evaluating the Proper Surgical Safety Margin for Early Stage Oral Tongue Cancers: A Prospective Multicenter Randomized Non-inferiority Clinical Trial
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:
Read more
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.
Read the 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
- Being tested
- 1.5 cm surgical safety margin for cT1-2N0 oral tongue cancers, 1.0 cm surgical safety margin for cT1-2N0 oral tongue cancers
- Keywords
- Tongue cancer, Surgery, Safety margin
- Medical subject headings
- Tongue Neoplasms, Margins of Excision, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.5 cm surgical safety margin for cT1-2N0 oral tongue cancersProcedure or surgery
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).
1.0 cm surgical safety margin for cT1-2N0 oral tongue cancersProcedure or surgery
Surgical resection including 1.0 cm normal tissue around the gross tumors
| Study group | Role | What they receive |
|---|---|---|
| Wide surgical safety margin | Active comparator | 1.5 cm safety margin surgery for cT1-2N0 oral tongue cancer Receives: 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 Receives: Procedure: 1.0 cm surgical safety margin for cT1-2N0 oral tongue cancers |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 year local control rate
At 2 years after the completion of treatment, % of local control (or recurrence rate)
Measured: 2 year
Secondary outcomes (3)
5 year recurrence free survival
5 year disease control rate
Measured: 5 year
Speech function
Articulation score A seven-point articulation score (7: Within normal limits, 6 Mild-slight distortion and imprecision of consonants only, 5: Mild to moderate-all consonants targeted, 4: Moderate- at least 2 consonants placements acoustically distant from the target, 3: Moderate to marked-consonants and vowels both affected, 2: Marked- uses adaptive compensatory articulation for all lingual consonants, 1: Severe- does not use effective compensatory articulations) Reference: An objective assessment of speech and swallowing following free flap reconstruction for oral cavity cancers. Br J Plastic Surg 1996;49:363-9.
Measured: 2 year
Swallowing function
Swallowing performance status score. A seven-point swallowing performance scale (1: Normal, 2: Within functional limits, 3: Mild impairment, 4, Mild-moderate, 5, Moderate, 6: Moderate-severe, 7: Severe impairment). (Reference: Swallowing Function in Patients With Head and Neck Cancer Prior to Treatment Arch Otolaryngol Head Neck Surg. 2000;126(3):371-377.)
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start18 Jan 2021
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Why it stopped: Due to Korean medical crisis, Resident strike, Patient referral (tongue cancer patients) to tertiary center has been in hold. Patient recruitment was seriously affected, and decreased.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tongue CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Asan Medical Center, Ajou University School of Medicine, National Cancer Center, Korea, Inje University, Seoul National University Bundang Hospital, Kangbuk Samsung Hospital, Dong-A University Hospital
- Responsible party
- Principal investigator, Han-Sin Jeong, Samsung Medical Center
- Investigators
- Han-Sin Jeong, MD PhD, Principal investigator, Head and Neck Cancer Center, Samsung Medical Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738786
- Sponsor's protocol ID
- 2020-08-012
- Status last verified
- May 2025
- First submitted
- 31 Jan 2021
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will make our participant data available to other researchers after completion of this study.
Publications
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.
PubMed 27519352
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Proper Surgical Safety Margin for Early Stage Oral Tongue Cancers: A Prospective Multicenter Randomized Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT04738786
- Acronym / sponsor ID
- 2020-08-012
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to Korean medical crisis, Resident strike, Patient referral (tongue cancer patients) to tertiary center has been in hold. Patient recruitment was seriously affected, and decreased.
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Asan Medical Center, Ajou University School of Medicine, National Cancer Center, Korea, Inje University, Seoul National University Bundang Hospital, Kangbuk Samsung Hospital, Dong-A University Hospital
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Wide surgical safety margin | Active comparator | Procedure: 1.5 cm surgical safety margin for cT1-2N0 oral tongue cancers1.5 cm safety margin surgery for cT1-2N0 oral tongue cancer |
| Narrow surgical safety margin | Active comparator | Procedure: 1.0 cm surgical safety margin for cT1-2N0 oral tongue cancers1.0 cm safety margin surgery for cT1-2N0 oral tongue cancer |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1.5 cm surgical safety margin for cT1-2N0 oral tongue cancersSurgical 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 or surgery | Wide surgical safety margin |
| 1.0 cm surgical safety margin for cT1-2N0 oral tongue cancersSurgical resection including 1.0 cm normal tissue around the gross tumors | Procedure or surgery | Narrow surgical safety margin |
Primary outcome
2 year local control rate
Time frame: 2 year
At 2 years after the completion of treatment, % of local control (or recurrence rate)
3 secondary outcomes
5 year recurrence free survival
Time frame: 5 year
Speech function
Time frame: 2 year
Swallowing function
Time frame: 2 year
Results and safety
The study was stopped early (reason given: Due to Korean medical crisis, Resident strike, Patient referral (tongue cancer patients) to tertiary center has been in hold. Patient recruitment was seriously affected, and decreased.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Background: PubMed 27519352Jang 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.
- Individual participant dataSharing planned: No. The investigators will make our participant data available to other researchers after completion of this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han-Sin Jeong, MD PhD principal investigator
Head and Neck Cancer Center, Samsung Medical Center, Korea
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1.5 cm surgical safety margin for cT1-2N0 oral tongue cancers and 1.0 cm surgical safety margin for cT1-2N0 oral tongue cancers in people with Tongue Cancer and Tongue Cancer TNM Staging Primary Tumor (T) T1, run by Samsung Medical Center at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to Korean medical crisis, Resident strike, Patient referral (tongue cancer patients) to tertiary center has been in hold. Patient recruitment was seriously affected, and decreased.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 year local control rate (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04738786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.