PDF(Pubmed)
Abstract：
BACKGROUND: Sensitive and reproducible detection of residual disease after treatment is a major challenge for patients with locally advanced head and neck cancer. Indeed, the current imaging techniques are not always reliable enough to determine the presence of residual disease. The aim of the NeckTAR trial is to assess the ability of circulating DNA (cDNA), both tumoral and viral, at three months post-treatment, to predict residual disease, at the time of the neck dissection, among patients with partial cervical lymph node response on PET-CT, after potentiated radiotherapy.
METHODS: This will be an interventional, multicentre, single-arm, open-label, prospective study. A blood sample will be screened for cDNA before potentiated radiotherapy and after 3 months if adenomegaly persists on the CT scan 3 months after the end of treatment. Patients will be enrolled in 4 sites in France. Evaluable patients, i.e. those with presence of cDNA at inclusion, an indication for neck dissection, and a blood sample at M3, will be followed for 30 months. Thirty-two evaluable patients are expected to be recruited in the study.
CONCLUSIONS: The decision to perform neck dissection in case of persistent cervical adenopathy after radio-chemotherapy for locally advanced head and neck cancer is not always straightforward. Although studies have shown that circulating tumour DNA is detectable in a large proportion of patients with head and neck cancer, enabling the monitoring of response, the current data is insufficient to allow routine use of this marker. Our study could lead to better identification of patients who do not have residual lymph node disease in order to avoid neck dissection and preserve their quality-of-life while maintaining their prospects of survival.
BACKGROUND: Clinicaltrials.gov: NCT05710679, registered on 02/02/2023, https://clinicaltrials.gov/ct2/show/ . Identifier with the French National Agency for the Safety of Medicines and Health Products (ANSM): N°ID RCB 2022-A01668-35, registered on July 15th, 2022.
METHODS: This will be an interventional, multicentre, single-arm, open-label, prospective study. A blood sample will be screened for cDNA before potentiated radiotherapy and after 3 months if adenomegaly persists on the CT scan 3 months after the end of treatment. Patients will be enrolled in 4 sites in France. Evaluable patients, i.e. those with presence of cDNA at inclusion, an indication for neck dissection, and a blood sample at M3, will be followed for 30 months. Thirty-two evaluable patients are expected to be recruited in the study.
CONCLUSIONS: The decision to perform neck dissection in case of persistent cervical adenopathy after radio-chemotherapy for locally advanced head and neck cancer is not always straightforward. Although studies have shown that circulating tumour DNA is detectable in a large proportion of patients with head and neck cancer, enabling the monitoring of response, the current data is insufficient to allow routine use of this marker. Our study could lead to better identification of patients who do not have residual lymph node disease in order to avoid neck dissection and preserve their quality-of-life while maintaining their prospects of survival.
BACKGROUND: Clinicaltrials.gov: NCT05710679, registered on 02/02/2023, https://clinicaltrials.gov/ct2/show/ . Identifier with the French National Agency for the Safety of Medicines and Health Products (ANSM): N°ID RCB 2022-A01668-35, registered on July 15th, 2022.
摘要：
背景：治疗后对残留疾病的敏感和可重复检测对于局部晚期头颈部癌症患者来说是一个重大挑战。的确,目前的成像技术并不总是足够可靠的来确定残留疾病的存在。NeckTAR试验的目的是评估循环DNA（cDNA）的能力，肿瘤和病毒，治疗后三个月，预测残留疾病，在颈部解剖的时候,在PET-CT上有部分颈淋巴结反应的患者中，强化放疗后。
方法：这将是一个介入，多中心,单臂,开放标签，前瞻性研究。在强化放疗之前和3个月后，如果在治疗结束后3个月的CT扫描中持续存在腺肿大，则将筛选血液样品的cDNA。患者将在法国的4个地点登记。宝贵的患者，即包含cDNA的那些，颈部夹层的指征,和M3的血液样本，将随访30个月。预计将招募32名可评估患者。
结论：在局部晚期头颈部肿瘤放化疗后持续性宫颈腺病的情况下进行颈部清扫的决定并不总是简单的。尽管研究表明循环肿瘤DNA在大部分头颈部癌症患者中都能检测到，能够监测反应，当前数据不足以允许常规使用此标记。我们的研究可以更好地识别没有残留淋巴结疾病的患者，以避免进行颈部淋巴结清扫并保持其生活质量，同时保持其生存前景。
背景：Clinicaltrials.gov：NCT05710679，于2023年2月2日注册，https://clinicaltrials.gov/ct2/show/。法国国家药品和健康产品安全局（ANSM）的标识符：N°IDRCB2022-A01668-35，于7月15日注册，2022年。
方法：这将是一个介入，多中心,单臂,开放标签，前瞻性研究。在强化放疗之前和3个月后，如果在治疗结束后3个月的CT扫描中持续存在腺肿大，则将筛选血液样品的cDNA。患者将在法国的4个地点登记。宝贵的患者，即包含cDNA的那些，颈部夹层的指征,和M3的血液样本，将随访30个月。预计将招募32名可评估患者。
结论：在局部晚期头颈部肿瘤放化疗后持续性宫颈腺病的情况下进行颈部清扫的决定并不总是简单的。尽管研究表明循环肿瘤DNA在大部分头颈部癌症患者中都能检测到，能够监测反应，当前数据不足以允许常规使用此标记。我们的研究可以更好地识别没有残留淋巴结疾病的患者，以避免进行颈部淋巴结清扫并保持其生活质量，同时保持其生存前景。
背景：Clinicaltrials.gov：NCT05710679，于2023年2月2日注册，https://clinicaltrials.gov/ct2/show/。法国国家药品和健康产品安全局（ANSM）的标识符：N°IDRCB2022-A01668-35，于7月15日注册，2022年。
