Clinical Study Evaluating the Proper Surgical Safety Margin for Early Stage Oral Tongue Cancers: A Prospective Multicenter Randomized Non-inferiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 125
- 试验地点
- 5
- 主要终点
- 2 year local control rate
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven oral tongue squamous cell carcinoma
- •Stage cT1-2N0M0 tumors
- •Treatment-naïve tumor
- •American Society of Anesthesiologists (ASA) physical status classification 1-
- •Patients who give a written informed consent voluntarily.
排除标准
- •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.
结局指标
主要结局
2 year local control rate
时间窗: 2 year
At 2 years after the completion of treatment, % of local control (or recurrence rate)
次要结局
- Swallowing function(2 year)
- Speech function(2 year)
- 5 year recurrence free survival(5 year)
研究者
Han-Sin Jeong
Director of Head and Neck Cancer Center
Samsung Medical Center