Clinical trial NCT04738786: Clinical Study Evaluating the Proper Surgical Safety Margin for Early Stage Oral Tongue Cancers
Official title: Clinical Study Evaluating the Proper Surgical Safety Margin for Early Stage Oral Tongue Cancers: A Prospective Multicenter Randomized Non-inferiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
name: Asan Medical Center
name: Ajou University School of Medicine
name: National Cancer Center, Korea
name: Inje University
name: Seoul National University Bundang Hospital
name: Kangbuk Samsung Hospital
name: Dong-A University Hospital
First posted: 2021-02-04
Enrollment: 125
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 2 year local control rate
timeFrame: 2 year
Secondary outcomes:
measure: 5 year recurrence free survival
timeFrame: 5 year
measure: Speech function
timeFrame: 2 year
measure: Swallowing function
timeFrame: 2 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou university School of Medicine
Study officials:
affiliation: Head and Neck Cancer Center, Samsung Medical Center, Korea
name: Han-Sin Jeong, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.