NCT05650034招募中不适用
Post-Operative Radiotherapy De-Escalation of Negative Nodal Regions in Head and Neck Squamous Cell Carcinoma
National Cancer Institute, Egypt2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2021年4月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Regional failure in the omitted/de-escalated elective nodal irradiation site
研究概览
简要总结
This is a non-randomized prospective trial evaluating the non- inferiority of de-escalating the volume and/or dose of elective nodal irradiation in post-operative head and neck squamous cell carcinomas.
详细描述
This is a non-randomized prospective trial evaluating the non-inferiority of volume and/or dose de-escalation of elective nodal irradiation in post-operative head and neck squamous cell carcinomas with assessment of toxicity profiles.
57 head and neck squamous cell carcinoma cases eligible for post-operative radiotherapy will be recruited and managed according to tumor laterality, nodal status, and laterality of nodal dissection (ipsilateral/ bilateral nodal dissection).
Ipsilateral nodal dissection:
- If ipsilateral N0, bilateral nodal irradiation will be omitted.
- If ipsilateral N positive and tumor was well lateralized, contralateral nodal negativity will be assessed by PETCT. IF PETCT is free, the ipsilateral nodal regions will be irradiated with conventional doses while the contralateral nodal irradiation will be omitted.
- If ipsilateral N positive and tumor was not well lateralized, ipsilateral nodal regions will be irradiated with conventional doses while the contralateral nodal irradiation will be de-escalated to 40 Gy dose equivalent.
- Cases with PETCT positive for malignancy will be excluded from the study.
Bilateral nodal dissection:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a Karnofsky performance score of 70% or more.
- •Completely or partially resected head and neck SCC. This includes: The oral cavity (lips, buccal mucosa, oral tongue, floor of mouth, gingiva, retromolar trigone, and hard palate), maxilla, oropharynx, and larynx.
- •Patients with at least an ipsilateral neck dissection.
- •Patient has at least one pathological feature that is an indication for PORT: positive or close (<5 mm) margin, presence of LVI or PNI, pT3 or pT4 disease, positive lymph nodes, or ENE.
- •Pathologically lymph node negative in at least one dissected hemi-neck or PET-CT
排除标准
- •Patients with bilaterally involved neck nodes
- •Patients with pT3-T4 tumors involving midline who undergo an ipsilateral neck dissection (unless a contralateral neck dissection is performed)
- •Serious medical comorbidities or other contraindications to radiotherapy
- •Prior history of head and neck cancer within 5 years
- •Any other active invasive malignancy
- •Prior head and neck radiation at any time
- •Prior oncologic head and neck surgery in the oral cavity or neck.
- •Known metastatic disease
- •Locoregional disease recurrence identified following surgical resection but prior to start of radiotherapy
- •Inability to attend full course of radiotherapy or follow-up visits 11.Unable or unwilling to complete QoL questionnaires
结局指标
主要结局
Regional failure in the omitted/de-escalated elective nodal irradiation site
时间窗: Baseline to 1 year
次要结局
- Acute toxicity(Baseline to 6 months)
- Late toxicity(Baseline to 1 year)
- Overall survival(Baseline to 2 years)
研究者
研究点 (2)
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