A Multi-centre Randomised Phase III Trial Comparing PET-CT Guided Watch and Wait Policy Versus Planned Neck Dissection for the Management of Locally Advanced (N2/N3) Nodal Metastases in Patients With Head and Neck Squamous Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 560
- 试验地点
- 2
- 主要终点
- Overall survival at 2 years
研究概览
简要总结
RATIONALE: Imaging procedures, such as PET/CT scan, produce pictures of areas inside the body and may help doctors detect residual disease and plan the best treatment. Neck dissection is surgery to remove lymph nodes and other tissues in the neck. It is not yet known whether a neck dissection should always be performed in treating patients with head and neck cancer.
PURPOSE: This randomized phase III trial is studying PET/CT scan-guided watchful waiting compared with neck dissection of locally advanced lymph node metastases in treating patients who are undergoing chemotherapy and radiation therapy for primary head and neck cancer.
详细描述
OBJECTIVES:
- To compare the efficacy, in terms of overall survival, disease-specific survival, recurrence, quality of life, and cost-effectiveness, of a PET/CT scan-guided watch and wait policy with the current practice of planned neck dissection in the management of advanced (N2 or N3) nodal metastases in patients with primary head and neck squamous cell carcinoma undergoing chemoradiotherapy.
- To assess the predictive value of PET/CT scanning in detecting persistent or residual disease in the primary site.
OUTLINE: This is a multicenter study. Patients are stratified according to center, chemotherapy schedule (concurrent platinum vs concurrent cetuximab vs neoadjuvant and concurrent platinum vs neoadjuvant docetaxel, platinum, and fluorouracil with concurrent platinum), T stage (T1-T2 vs T3-T4), and N stage (N2a-N2b vs N2c-N3). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive standard concurrent chemoradiotherapy (CRT). Patients undergo PET/CT scan at 9-13 weeks after completion of CRT. Patients with complete response of primary site undergo neck dissection within 4 weeks.
- Arm II: Patients undergo neck dissection and then receive standard CRT. Patients undergo PET/CT scan at 9-13 weeks after completion of CRT.
Patients are assessed periodically for quality-of-life. Tissue and blood samples collected periodically are stored for future research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Diagnostic
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed head and neck squamous cell carcinoma (HNSCC), including any of the following subtypes:
- •Oropharyngeal
- •Laryngeal
- •Hypopharyngeal
- •No primary nasopharyngeal carcinoma
- •Must have clinical and CT/MRI evidence of nodal metastases staged N2 (a, b, or c) or N3
- •No occult nodal metastasis (i.e., large nodal metastasis but no proven primary site on clinical assessment)
- •No N1 nodal metastasis
- •Planning to receive curative radical concurrent chemoradiotherapy (approved by study) for primary disease
- •Patients undergoing neoadjuvant chemotherapy followed by concurrent chemoradiotherapy are eligible
- •Able to undergo neck dissection surgery
- •No current resection for primary tumor planned (e.g., resection of tonsil or base of tongue with flap reconstruction [diagnostic tonsillectomy allowed])
- •No distant metastases to chest, liver, bones, or other sites
- •PATIENT CHARACTERISTICS:
- •Not pregnant
- •No other cancer diagnosis within the past 5 years except basal cell carcinoma or cervical carcinoma in situ
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior treatment for HNSCC
- •No concurrent neoadjuvant chemoradiotherapy without concurrent chemotherapy
- •No concurrent adjuvant chemotherapy
- •No concurrent chemoradiotherapy for palliative purposes
- •No concurrent radiotherapy alone
排除标准
- 未提供
结局指标
主要结局
Overall survival at 2 years
Health economics using quality adjusted life years
次要结局
- Disease-specific survival
- Recurrence and local control in neck
- Utility cost
- Quality of life
- Complication rates
- Accuracy of PET-CT scanning for assessing primary tumor