Neck Dissection Versus Radiotherapy for Cervical Lymph Node Metastasis in Advanced Hypopharyngeal Carcinoma With Poor Response to Induction Chemotherapy : A Randomized Controlled Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Neck control rates
研究概览
简要总结
At the time of diagnosis, approximately 60%-80% of patients with hypopharyngeal cancer are found with cervical lymph node metastasis. Cervical nodal metastasis is an important prognostic factor in hypopharyngeal cancer. Induction chemotherapy is frequently used in advanced hypopharynx cancer. However, sometimes CR was obtained at the tumor's primary site but not in the palpable lymph nodes in the neck, the large cervical lymph node metastasis poorly responded to induction chemotherapy in a considerable percentage of patients. At present, patients with primary tumor achieved CR preferred to receive definitive radiotherapy no matter cervical lymph node metastasis SD or progression. But, radiotherapy was poor effective to the big cervical lymph node metastasis, because the inner of big cervical lymph node metastasis was hypoxic and necrosis. The investigators conducted a prospective, randomised trial to compare neck dissection with definitive radiotherapy for advanced hypopharyngeal cancer cervical lymph node metastasis with poor response to induction chemotherapy.
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
- •Histological/ cytological/ Imaging examination proven hypopharyngeal squamous-cell carcinoma in preoperative assessment
- •Advanced hypopharyngeal cancer with metastatic cervical lymph node more than 2cm in diameter
- •EPOG≤1,KPS≥ 70
- •No contraindication of surgery and radiotherapy
- •No serious disease history of the heart, liver, kidney, lung and other important organs
- •Expected survival period≥ 12 months
- •Good compliance
排除标准
- •Inability to provide an informed consent
- •Other malignancy tumor history,(except for cured skin basal cell carcinoma and papillary thyroid carcinoma)
- •Serious cardiovascular, liver, respiratory, kidney and neurologic and psychiatric disease with clinical symptoms
- •The patient has received prior surgery or radiotherapy (except for biopsy)
- •The patient has received chemotherapy or immunotherapy
- •Pregnant or lactating women
- •Other disease requiring simultaneous surgery or radiotherapy
研究组 & 干预措施
Neck dissection group
Neck dissection followed by radiotherapy(50Gy) according to risk factors
干预措施: Neck dissection followed by radiotherapy(50Gy) according to risk factors (Procedure)
Radiotherapy group
Definitive radiotherapy (70Gy)
干预措施: Definitive radiotherapy (Radiation)
结局指标
主要结局
Neck control rates
时间窗: 2 years
The percentage of patients without cervical lymph node metastasis
次要结局
- Disease-free survival(5 years)
- Overall survival(5 years)
- Quality of life(QOL) QLQ-HN35(1 year)
- Quality of life(QOL) QLQ-C30(1 year)
- Disease-free survival(1 year)
- Disease-free survival(2 years)
- Disease-free survival(3 years)
- Overall survival(3 years)