Postoperative Radiotherapy for Early-stage Oral Tongue Squamous Cell Carcinoma Patients With Risk Factors: a Prospective, Multicenter, Randomized Controlled, Open-labelled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 190
- 试验地点
- 28
- 主要终点
- 3-year DFS
研究概览
简要总结
The goal of this clinical trial is to learn whether postoperative radiotherapy can delay disease recurrence in patients with early-stage oral squamous cell carcinoma who have high-risk factors. The main question it aims to answer is: Is the clinical outcome of early-stage tongue squamous cell carcinoma patients with risk factors after tumor enlargement resection receiving postoperative radiotherapy better than that of patients with simple follow-up observation? How is the safety? Researchers will compare the postoperative radiotherapy group and the simple follow-up observation group to see if there are differences between the two groups in terms of 3-year disease-free survival rate, 5-year disease-free survival rate, overall survival rate, toxicity events, and quality of life.
Participants of postoperative radiotherapy group will receive postoperative radiotherapy 6-8 weeks after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years old and ≤ 70 years old, gender not limited;
- •Newly treated patients (who have not undergone radiotherapy, chemotherapy, or targeted therapy before);
- •Complete resection of the tumor with naked eye and no residual tumor observed in postoperative pathology;
- •The lesion is limited to the anterior 2/3 of the tongue (active part of the tongue);
- •Postoperative pathological diagnosis was squamous cell carcinoma of the tongue;
- •According to AJCC 8th edition, the pathological TNM staging is T1-2N0M0;
- •Having at least one risk factor: vascular cancer thrombus, nerve invasion, moderate or low differentiation;
- •The general status score of the Eastern Cancer Collaboration Group (ECOG) is 0-2 points;
- •Not participating in other clinical trials within the previous 4 weeks prior to screening; If other trials fail to screen cases, but meet the requirements of this trial, they can be enrolled.
排除标准
- •Patients who invade the oropharynx, mouth floor, cheeks, neck, and other organs;
- •Have received chemotherapy or other anti-tumor drugs;
- •Previously received radiation therapy for the head and neck area;
- •Patients with active autoimmune diseases that require systemic treatment in the past;
- •Pregnant or lactating women;
- •Individuals with acute infections that are difficult to control;
- •Patients with drug abuse, drug abuse, long-term alcoholism and AIDS;
- •The subjects also have other known invasive malignant tumors (excluding those with no evidence of tumor recurrence through treatment and a duration of more than 2 years);
- •Researchers believe that there are other conditions that hinder patients from participating in this trial.
研究组 & 干预措施
PORT group
Patients should start radiotherapy immediately after the surgical wound has fully healed, usually 4 to 6 weeks after surgery, with a requirement of no later than 8 weeks after surgery
干预措施: Postoperative radiotherapy (Radiation)
control group
Patients will not receive special treatment and will undergo routine follow-up.
结局指标
主要结局
3-year DFS
时间窗: 3 years
The survival time of patients without significant tumor growth from the date of randomization. The appearance of new lesions is used as the criterion for recurrence (including recurrence of the primary lesion and surrounding tissues, cervical lymph node metastasis, and distant metastasis), and the time point of recurrence is the date of the first observation of measurable new lesions. The disease-free survival period will be defined as the time from randomization to death for patients who die from any other cause before disease recurrence is recorded. Patients who have not experienced disease recurrence or death (i.e. disease-free survival) during analysis will have the time of the last efficacy evaluation as the endpoint. For disease-free survival patients who have not undergone tumor evaluation since the baseline period, the first day of treatment will be used as the endpoint of disease-free survival. Calculate the 3-year disease-free survival rate of all patients after follow-up.
次要结局
- scores of Quality of life(From enrollment to 5 years)
- 5-year OS(5 years)
- 5-year DFS(5 years)
- acute toxicity events(6 months)
- Long-term toxicity events(from 6 months after treatment to 5 years after treatment)
研究者
Qichun Wei, MD, PhD
professor of medicine
Second Affiliated Hospital, School of Medicine, Zhejiang University