A Prospective Phase II Clinical Trial on the Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- 2-year region-free recurrence survival (RRFS)
研究概览
简要总结
To explore the control rate and quality of life of participants with late head and neck squamous cell carcinoma who have obtained postoperative pCR after cervical lymph node surgery with neoadjuvant chemotherapy combined with immunotherapy, and the cervical lymph node removal prophylactic irradiation ENI in the low-risk area.
详细描述
In order to understand whether it can better protect normal tissues such as pharyngeal constriction muscles, thyroid, parotid glands, and submandibular glands without affecting the efficacy of tumors, and reduce the negative impact of radiotherapy on immunotherapy, the investigators plan to conduct a prospective phase II study to explore the control rate and quality of life of patients with late head and neck squamous cell carcinoma who have obtained postoperative pCR after cervical lymph node surgery with neoadjuvant chemotherapy combined with immunotherapy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative pathologically confirmed initial treatment of head and neck squamous cell carcinoma
- •Receive neoadjuvant chemotherapy combined with PD-1 monoclonal antibody immunotherapy, and meet one of the following conditions: Preoperative clinical stage was T3-T4 or N2-N3 (AJCC 8th edition). Patients with oral cancer/oropharyngeal cancer had positive lymph nodes in the IV/V region with imaging diagnosis or biopsy confirmation before surgery. HPV/ P16-positive oropharyngeal cancer patients with clinical lymph node invasion (ENE), one positive cervical lymph node > 3cm or multiple positive cervical lymph nodes before surgery
- •The pathology of at least one cervical lymph node was determined by pCR；
- •Karnofsky's physical status score ≥70 points；
- •Age: 18 ~ 70 years old；
- •Laboratory examination results within 1 week before enrollment met the following conditions: neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥ 75×109/L
- •Patients participate voluntarily and sign informed consent forms.
排除标准
- •Previous head and neck radiation treatment
- •Severe complications；
- •Pregnant or lactating women
- •Who were deemed unsuitable for inclusion by the researchers.
研究组 & 干预措施
Trial Group
All patients received intensity-modulated conformal radiotherapy (IMRT). To ensure study quality, all IMRT plans were reviewed by the research team at Sun Yat-sen University Cancer Center. The delineation principles for the radiotherapy target volume of the primary tumor bed and normal tissues followed the consensus guidelines.
(1) Tumor bed (CTVtb): It was delineated based on the tumor extent shown in laryngoscopy, enhanced CT/MRI, or PET CT before induction therapy49. For patients with significant anatomical changes due to tumor regression, the CTVtb was adjusted, taking into account the patient's anatomy after induction chemotherapy and the initial state of the tumor; if a cavity appeared due to tumor regression, it was adjusted according to natural anatomical boundaries.(2) High-risk clinical target volume (CTV1): CTVtb plus a 5-10mm margin, with a prescribed dose of at least 60Gy in 30 fractions.
(3) Low-risk clinical target volume (CTV2): CTV1 plus a 5-10mm margin. For hypo
干预措施: Head and Neck Cancers (Radiation)
结局指标
主要结局
2-year region-free recurrence survival (RRFS)
时间窗: 2-year
Time to confirmed diagnosis of documented recurrence of cervical lymph nodes or death from any cause
次要结局
- Progression-free survival (PFS)(2-year)
- Distant metastasis-free survival (DMFS)(2-year)
- Overall survival (OS)(2-year)
- Local recurrence-free survival (LRFS)(2-year)
- Acute and Late Radiation Injuries(Day 1 of radiotherapy to 2 years post-treatment)
- Quality of life assessment(Baseline, during radiotherapy, at the end of radiotherapy, 3 months after the end of radiotherapy, 6 months after the end of radiotherapy, and thereafter according to routine follow-up until 2 years.)
研究者
Chen Chunyan
Clinical Professor
Sun Yat-sen University