A Prospective Randomized Controlled Trial of Functional Organ Preservation Surgery vs. Chemoradiotherapy for Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- Organ preservation rate
研究概览
简要总结
This is a prospective randomized controlled trial comparing functional organ preservation surgery (FOPS) vs. radiotherapy or chemoradiotherapy as the first treatment modality for patients with head an neck squamous cell carcinoma arising in the oropharynx, larynx and hypopharynx. This study has a hypothesis that the FOPS is an effective treatment strategy to preserve the organ function without compromising oncologic safety and survival.
详细描述
This prospective study compare the following items between two groups:
- Functional outcomes: laryngeal, pharyngeal, and quality of life
- Oncological outcomes: survivals, locoregional controls
- Combined imaging and molecular biomarkers with follow-up data
The functional organ preservation surgery (FOPS) is defined as a surgery preserving the laryngeal or pharyngeal function regardless of open or transoral route. The FOPS may include:
- Radical tonsillectomy or other oropharyngeal resection
- Partial laryngectomy or pharyngectomy
- Transoral laser microresection
- Transoral robotic surgery (TORS)
- Reconstructive surgery may be combined with primary resection
- Neck dissection may be indicated in some patients
- Postoperative radiotherapy or chemoradiotherapy may be indicated in some patients according to their pathologic reports.
The standard concurrent chemoradiotherapy (CRT) is generally used but radiotherapy (RT) alone may be indicated for some patients under tumor-board discussion. The salvage surgery may be indicated for patients with residual or recurrent diseases after CRT or RT.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with squamous cell carcinomas arising in the oropharynx, larynx, or hypopharynx
- •Resectable tumors without distant metastases
- •age range: 18-80 years
- •Pretreatment Karnofsky performance scale > or 70%
- •Operable patients
- •No significant loss of pretreatment larynx and pharyngeal functions
排除标准
- •Patients with a present or previous history of other cancers except benign tumors, premalignant lesions, carcinoma-in-situ (at some organ sites), well-differentiated thyroid carcinoma and low-grade salivary gland cancers (from tumor-board decision whether the tumors significantly affect the survival outcomes)
- •Other organ-site cancers
- •Low-performance status or non-operable patients
- •Non-resectable or distant-metastatic tumors
- •Extensive primary or neck nodal diseases
- •Significant pretreament loss of laryngeal or pharyngeal functions
- •cT1N0 glottic carcinomas
研究组 & 干预措施
FOPS
- Functional organ preservation surgery (FOPS) group as a first-line treatment modality
- Postoperative RT or CRT may be included for the patients of this group
干预措施: FOPS (Procedure)
CRT
- Concurrent chemoradiotherapy or radiotherapy group as a first-line treatment modality
- Salvage surgery may be applied for the patients for persistent or recurrent cancers after CRT or RT
干预措施: CRT (Radiation)
结局指标
主要结局
Organ preservation rate
时间窗: 2 years
The larynge and pharyngeal functions are compared between two groups. The time frame may be extended to 5 years.
次要结局
- Survival rate(2 years)
- Locoregional control rate(2 years)
研究者
Jong-Lyel Roh
MD, PhD
Asan Medical Center