The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Neck control rates
研究概览
简要总结
Cervical nodal metastasis is the most certain prognostic factor in oral cancer. Appropriate management of the neck is therefore of paramount importance in the treatment of oral cancer. However, there is still some controversy on the treatment of early maxillofacial malignancies. Currently, investigators have no accurate uniform treatment standards, including the National Comprehensive Cancer Network (NCCN) recommended between surgery and radiotherapy options. Clinical evaluation indicated that lymph node-negative patients eventually 25%-35% had cervical node metastasis. Therefore, for the majority of patients with true node-negative, preventive cervical lymph node dissection is obviously over-treatment, and lower quality of life. Radiotherapy can avoid such surgery.
详细描述
Objective: To evaluate the effect of radiotherapy on the neck of early oral cancer with poor pathologic factors.
This is a randomized, prospective, open, multicenter study. Intervention: Patients receive primary tumor resection followed by radiotherapy.
Control: Patients receive primary tumor resection with selective neck dissection.
Primary:
2 years neck control rates
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
- •Ability to understand and the willingness to sign a written informed consent document
- •Age≥ 18 and≤ 75 years
- •Clinical/ Histological/ cytological/ Imaging examination proven Oral/Oropharynx Squamous-cell carcinoma (Tongue, buccal mucosa, mouth floor, hard palate, Molar area), the depth of invasion > 4mm in preoperative assessment
- •In line with clinical stage I / II stage (T1-2 N0 M0; AJCC 2010) and receiving surgical resection
- •Normal bone marrow reserve function and normal liver, kidney function
- •Expected survival period≥ 6 months
排除标准
- •Inability to provide an informed consent
- •Evidence of oral distant metastasis or other malignancies
- •The patient has received prior surgery for primary tumor or lymph node ( except for biopsy )
- •Prior radiotherapy for primary tumor
- •The patient has previously received anti-tumor biological targeted therapy
- •The patient has received chemotherapy or immunotherapy for primary tumors
- •Prior malignancy within the previous 5 years (except for cured skin basal cell carcinoma or cervical carcinoma in situ)
- •With 3-4 grad Allergy to any drug in the treatment
- •Peripheral neuropathy> 1 grade
- •Any unstable systematic disease (including active infection, uncontrolled high blood pressure, unstable angina, onset of angina within the last 3 months, congestive heart failure, myocardial infarction within the previous 12 months, severe arrhythmia needing drug treatment, liver, kidney or metabolic disease)
- •HIV positive
- •Chronic diseases requiring immune agents or hormone therapy
- •Pregnant or lactating women
- •Drug/alcohol abuse, psychological or spiritual illness that may interfere compliance to the study
- •Patients with epilepsy requiring medications (such as steroids or antiepileptic drugs)
- •The patient has participated in other experimental therapy studies within 30 days
- •Researchers believe that the situation is unsuitable for participation in the group
结局指标
主要结局
Neck control rates
时间窗: 2 years
次要结局
- Overall survival(5 years)
- Disease-free survival(5 years)
研究者
Chenping Zhang
Principal Investigator,Head of Oral and Maxillofacial- Head and Neck Oncology
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University