A Bidirectional Study of Individualized Postoperative Adjuvant Treatment Decision Model for Locally Advanced Head and Neck Squamous Cell Carcinoma Based on Multimodal Dynamic Data
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 571
- 试验地点
- 1
- 主要终点
- 2-year progress-free survival
研究概览
简要总结
Based on multimodal data, the investigators establish a dynamic deep learning model to conduct prognostic risk assessment for patients and recommend the 'most suitable' treatment/follow-up regimen after radical treatment, assisting clinicians in improving homogenized evaluation levels and achieving individualized precision therapy, thereby providing scientific evidence for the currently widely debated selection of postoperative adjuvant therapy in locally advanced head and neck squamous cell carcinoma patients.
详细描述
This clinical study is an observational bidirectional study. A retrospective cohort is used to train the model for recurrent risk prediction and adjuvant treatment decision-making, while a prospective cohort serves as an external validation set to verify the model performance.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Age >= 18 years.
- •Patients diagnosed and treated at Nanfang Hospital, Southern Medical University or its cooperative hospitals between January 2017 and December
- •Patients who either seek medical treatment after June 2022 or sought medical treatment before that but have not lost contact with the hospital for more than 1 year are required to sign the informed consent form voluntarily.
- •Newly diagnosed head and neck squamous cell carcinoma (HNSCC) confirmed by histopathology.
- •Locally advanced disease without distant metastasis.
- •Complete clinical data (including patient demographics, tumor characteristics, treatment details, and prognostic variables).
- •Availability of MRI, CT, or PET-CT images before and after radical treatment.
排除标准
- •History of or coexisting secondary malignancies.
- •Lack of definitive radical treatment.
- •Absence of baseline or follow-up imaging (MRI/CT/PET-CT).
- •Investigator-determined unsuitability for study participation.
研究组 & 干预措施
Postoperative observation group
For observational studies, participants are not assigned an intervention as part of the study. Patients in this group received no postoperative adjuvant therapy and were only followed up regularly.
Postoperative concurrent chemoradiotherapy group
For observational studies, participants are not assigned an intervention as part of the study. Patients in this group received postoperative concurrent chemoradiotherapy. The specific regimen was as follows: a total radiation dose of 60-66 Gy was delivered in 30-33 fractions over a treatment course of 6-7 weeks. Chemotherapy consisted of either cisplatin monotherapy (75 mg/m², once every 3 weeks) or a combination of cisplatin and 5-fluorouracil (cisplatin 75 mg/m², 5-fluorouracil 750 mg/m², once every 3 weeks), administered concurrently with radiotherapy.
Postoperative radiotherapy group
For observational studies, participants are not assigned an intervention as part of the study. Patients in this group received postoperative radiotherapy alone. The specific regimen was as follows: a total radiation dose of 60-66 Gy was delivered in 30-33 fractions, over a total treatment course of 6-7 weeks.
结局指标
主要结局
2-year progress-free survival
时间窗: 2 years
From the initiation of treatment to the date of tumor progression (including local recurrence, regional lymph node metastasis, and distant metastasis) or tumor-related death, whichever occurs first. If no progression event was observed by the cutoff date of follow-up, the last follow-up date was used.
次要结局
- 2-year overall survival(2 years)
- 2-year recurrence-free survival(2 years)