Randomized Trial of Unilateral vs. Bilateral Neck Irradiation in Head and Neck Cancer Patients Treated With Primary Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Locoregional control
研究概览
简要总结
Patients with head and neck cancer typically undergo a surgical procedure to remove the lymph nodes that could contain disease on both sides of the neck. After surgery, radiotherapy is given (with or without chemotherapy) to the area that underwent surgery and both sides of the neck, even if disease was only found on one side. Giving radiotherapy to both sides of the neck commonly results in high rates of side effects, which in turn affects patient quality of life.
There is growing evidence from some other studies that support the safety of omitting radiotherapy after surgery in the side of the neck with no disease. With this study, the investigators are hoping to justify its routine use and, if successful, the standard of care could be to receive radiation on only one side of the neck instead of both sides. This could alleviate the extent of some side effects and improve patient quality of life.
Participants will be randomized into one of the following groups to receive radiotherapy as follows:
Arm 1 (Non-experimental intervention): standard intervention: Radiotherapy to both sides of the neck. Treatment will begin a maximum of 8 weeks from the surgery date.
Arm 2 (Experimental intervention): Radiotherapy to one side of the neck. Treatment will begin a maximum of 8 weeks from the surgery date.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with squamous cell carcinoma of the head and neck undergoing primary surgical management are eligible to participate if they meet the following eligibility criteria:
- •Primary site of disease in the oral cavity, oropharynx, larynx, or hypopharynx.
- •Squamous cell carcinoma confirmed by histology.
- •Bilateral modified radical or selective neck dissections carried out as part of primary surgery, with >= 10 lymph nodes removed from the contralateral neck
- •The contralateral neck is pathologically negative
- •Pre-surgical FDG-PET/CT scan did not show any clinically involved contralateral neck nodes.
- •Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.
排除标准
- •Previous radiation to the head and neck area
- •Pregnancy
- •Other contraindications to radiation treatment (e.g. severe connective tissue disease).
结局指标
主要结局
Locoregional control
时间窗: At 24 months
Locoregional failure is defined as disease recurrence (by imaging, clinical exam, or biopsy) in the neck or at the primary site.
次要结局
- Overall survival and disease-specific survival(5 years after diagnosis or the start of treatment.)
- University of Washington Quality of Life Questionnaire - Radiation Therapy Oncology Group (UW-QOL - RTOG) modification(At 6, 12, 18 and 24 months post radiotherapy)
- Xerostomia(At 6, 12, 18 and 24 months post radiotherapy)
- Acute toxicity(Weekly throughout RT treatment (approximately 6 weeks))