Phase II Clinical Trial to Evaluate the Exclusion of Cervical Volumes in Postoperative Irradiation of Locally Advanced Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Regional recurrence rate in non-irradiated cervical levels
研究概览
简要总结
The goal of this clinical trial is to learn if selectively omitting postoperative cervical irradiation is a safe and feasible treatment strategy for patients with resected, locally advanced squamous cell carcinoma of the head and neck (HNSCC) who underwent systematic neck dissection and have no high-risk nodal factors. The main questions it aims to answer are:
- Is the regional recurrence rate with selective omission of postoperative cervical irradiation non-inferior to the recurrence rate reported with standard complete nodal irradiation (6-8%)?
- Does selective omission of postoperative cervical irradiation reduce toxicity?
- Does selective omission of postoperative cervical irradiation improve immunological preservation and quality of life?
Researchers will compare outcomes in participants treated with this selective irradiation strategy to previously published data and to a retrospective institutional cohort treated with standard complete nodal irradiation, to see if it maintains regional control while reducing toxicity and preserving immune function and quality of life.
Participants will:
- Receive postoperative radiotherapy according to the new protocol, omitting irradiation of low-risk nodal levels
- Receive concomitant chemotherapy if clinically indicated, per standard practice
- Visit for checkups, blood sample collection, to complete quality-of-life questionnaires and attend follow-up visits over 48 months
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years of age
- •ECOG Performance Status (PS) ≤ 2
- •Histologically confirmed diagnosis of locally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
- •Resection of the primary tumor and unilateral and/or bilateral neck dissection performed according to standard guidelines, with detailed histological reporting by nodal level
- •Number of lymph nodes per dissected neck ≥ 18
- •No pathological lymph nodes following neck dissection (pN0)
- •Presence of a single pathological cervical lymph node following neck dissection (pN1), provided that:
- •No extracapsular extension
- •Diameter < 1 cm
- •No skip metastasis
- •Presence of risk factors indicating postoperative radiotherapy. Stages pT1-pT2N1 and pT3-pT4N0/N
- •If N1, all of the following criteria must be met: presence of a single cervical lymph node without extracapsular extension, diameter < 1 cm, and no skip metastasis
- •Patients may receive adjuvant systemic treatment if surgical margins are positive or close (< 5 mm)
排除标准
- •Absence of informed consent
- •Prior irradiation to the head and neck region
- •Prior surgery in the head and neck region
- •Contralateral neck dissection not performed when clinically indicated
- •History of malignancy within the previous 5 years, with the exception of non-melanoma skin cancer
- •Interval between surgery and radiotherapy > 8 weeks
研究组 & 干预措施
Selective postoperative radiotherapy
Postoperative IMRT or VMAT with selective cervical nodal irradiation based on pathological findings after neck dissection, omitting irradiation of low-risk cervical nodal levels.
干预措施: IMRT OR VMAT Radiotherapy excluding cervical radiation (Radiation)
结局指标
主要结局
Regional recurrence rate in non-irradiated cervical levels
时间窗: At 24 months
Rate to be compared to the recurrence rate reported with standard complete nodal irradiation (6-8%)
次要结局
- Local and Regional Progression-Free Survival(1 and 2 years)
- Distant Metastasis-Free Survival(1 and 2 years)
- Overall Survival(1 and 2 years)
- Incidence of Acute and Chronic Toxicity(3, 6, 12 and 24 months)
- Quality of Life - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(0, 6, 12, and 24 months)
- Quality of Life - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck 35 (EORTC QLQ-H&N35)(0, 6, 12, and 24 months)
- Treatment Adherence(Completion of radiotherapy (up to approximately 46 days))
- Incidence and Severity of Lymphopenia(Up to 24 months)