Elective Versus Therapeutic Neck Dissection in the Treatment of Early Node Negative Squamous Cell Carcinoma of the Oral Cavity
试验速览
- 阶段
- 不适用
- 入组人数
- 710
- 试验地点
- 2
- 主要终点
- Overall Survival
研究概览
简要总结
Cervical nodal metastasis is the single most important prognostic factor in head and neck cancers. Appropriate management of the neck is therefore of paramount importance in the treatment of these cancers. While it is obvious that the positive neck must be treated, controversy has always surrounded the clinically node negative neck with respect to the ideal treatment policy.The situation is difficult with regards to early cancers of the oral cavity (T1/T2). These cancers are usually treated with surgery where excision is through the per-oral route. Elective neck dissection in such a situation is an additional surgical procedure with its associated costs, prolonged hospitalization and may be unnecessary in as high as 80% of patients who finally turn out to be pathologically node negative. Should the neck be electively treated or there be a wait and watch policy? Current practice is that the neck is always addressed whenever there is an increased propensity to cervical metastasis or when patient follow-up is unreliable.
There is clearly a need therefore for a large randomized trial that will resolve the issue either way once and for all.
Primary Objective:
To demonstrate whether elective neck dissection (END) is equal or superior to the wait and watch policy i.e.
therapeutic neck dissection (TND) in the management of the clinically No neck in early T1 /T2 cancers of the oral cavity.
Secondary Objective:
- Does Ultrasound examination have any role in the routine initial workup of a node negative patient?
- How are patients ideally followed up -does sonography have a role or is clinical examination sufficient.
- Is assessment of tumor thickness by the surgeon at the time of initial surgery accurate -Is there a correlation
- Identify histological prognostic factors in the primary that may help identify a sub-set of patients at an increased risk for cervical metastasis.
详细描述
Stratification criteria:
- Size
- Sex
- Site
- Sonography
Randomization (I): All patients will be randomly allocated into one of two arms: wait and watch policy group or elective neck dissection group. Both arms will have similar wide excision of primary tumor in oral cavity per oral route.
Randomization (II): Following surgery and after complete recovery prior to discharge, patients will be randomized a second time for follow-up into two arms namely clinical examination versus clinical examination and ultrasonography of neck.
SURGICAL PROCEDURE:
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven T1 or T2 N0 M0 (clinical) squamous cell carcinoma of the buccal mucosa, lower alveolus, oral tongue and floor of mouth.
- •Surgery is the preferred treatment and the primary tumor can be excised with clear margins via the per-oral route.
- •No history of a prior malignancy in the head and neck region.
- •No prior malignancy outside the head and neck region in the preceding 5 years.
- •Patient will be reliable for follow-up
- •Age> 18 years and < 75 years.
- •No significant co-morbid conditions - ASA grade II and I.
- •Understands the protocol and is able to give informed consent.
排除标准
- •Prior radiotherapy or surgery for malignancy in the head and neck region.
- •Non squamous cell carcinomas of the oral cavity.
- •Upper alveolus and palatal lesions where there is a possibility of retropharyngeal node involvement.
- •Per-oral excision of tumor will compromise margins in the opinion of the treating surgeon.
- •Significant co-existing pre-malignant conditions like erytho-leucoplakia and oral sub mucous fibrosis that in the opinion of the clinician would interfere in the planned treatment management of the patient.
结局指标
主要结局
Overall Survival
时间窗: 5 years
survival would be calculated as time period between date of randomization and date of death from any cause or last follow up
次要结局
- Correlation between the tumour thickness assessment by surgeon on table , on frozen section and final histopathology.(Within 2 weeks after surgery)
- Identify histological prognostic factors in primary that may help identify a sub-set of patients at an increased risk of cervical metastasis.(upto 5 years)
- Disease free survival(5 years)
- Role of ultrasound examination in routine initial workup of a node negative patient.(5 years)
- Role of ultrasonogrphy vs clinical examination in ideal follow up of patient.(5 years)
研究者
A K D'Cruz
MS, DNB, FRCS (Hon.)
Tata Memorial Hospital