Randomized Multicentric Comparative Study Between a Conventional and an Intensive Follow up Strategy After Treatment of a Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
Phase III randomized trial to compare the efficacy in terms of overall survival of two follow-up strategies (conventional versus intensive) among smokers and/or alcohol drinkers patients, older than 35 year, in complete remission 2-4 months after treatment of head and neck squamous cell carcinoma Patients will be randomized after the post-treatment check-up (clinical examination and reference imaging including PET-CT for patients ≥ N2) performed 2 to 4 months after the end of treatment. The randomization ratio is 1:1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged superior to 35 years
- •Current or previous smokers (smoked more than 10 packs year) or alcohol drinkers (current or previous, more than 140 g alcohol per week) or both
- •Histologically proven invasive HNSCC stage 0 to IVa, excluding T4b and nasopharynx. Patients with in situ carcinoma are eligible.
- •Treated with curative intent
- •Free of cancer at the post-treatment clinical and radiological examination (negative PET-CT for N≥2) at least 2 months after the end of the last treatment and no later than 4 months after. If there is a strong doubt of lack of complete remission (for example if more exams or longer follow-up are needed to affirm or deny complete remission), the patient is not eligible for the trial.
- •Remark: Patients with several head and neck squamous cell carcinoma (concomitant or successive), all treated with curative intent and all in complete remission, are eligible.
- •Agree to have a long term follow-up
- •Signed informed consent
- •Patient affiliated to a social security system or beneficiary of the same
排除标准
- •Pregnant or breastfeeding women
- •Severe psychiatric condition that may inhibit protocol participation and in the judgment of the investigator would make the patient inappropriate for entry into this study.
- •Impossibility to perform the planned exams of the intensive strategy
- •Nasopharyngeal carcinoma
- •Other malignancies within 5 years prior to randomization that needs followup by PET-scan or chest CT or head and neck CT/MRI
- •Any disease that needs follow-up by regular upper digestive endoscopy
研究组 & 干预措施
Conventional follow-up
clinical examination with nasofibroscopy every 1-3 months first year post-treatment, every 2-4 months second year, every 4-6 months third year (mean of around 13 visits) and every 6 months thereafter. Low Dose Chest CTscan every year in patients with tobacco consumption history of > 20 pack-year. Panendoscopy plus CT-scan are performed in case of clinical symptoms or abnormal clinical exam.
干预措施: Nasofibroscopy (Procedure)
Conventional follow-up
clinical examination with nasofibroscopy every 1-3 months first year post-treatment, every 2-4 months second year, every 4-6 months third year (mean of around 13 visits) and every 6 months thereafter. Low Dose Chest CTscan every year in patients with tobacco consumption history of > 20 pack-year. Panendoscopy plus CT-scan are performed in case of clinical symptoms or abnormal clinical exam.
干预措施: Low Dose Chest CTscan (Other)
Conventional follow-up
clinical examination with nasofibroscopy every 1-3 months first year post-treatment, every 2-4 months second year, every 4-6 months third year (mean of around 13 visits) and every 6 months thereafter. Low Dose Chest CTscan every year in patients with tobacco consumption history of > 20 pack-year. Panendoscopy plus CT-scan are performed in case of clinical symptoms or abnormal clinical exam.
干预措施: Biopsy (Procedure)
Intensive follow-up strategy
adding to the conventional follow-up strategy , an annual head&neck and thoracic injected CT-scan and Lugol upper gastrointestinal endoscopy (the first performed 12 months after inclusion), annual whole body PET-CT (the first at 6 months after inclusion). These 3 exams are performed every year during 3 years after inclusion (i.e. 3 CT-scan, 3 digestive endoscopies and 3 PET-CT per patient). Clinical follow up will be conducted as in the conventional follow up group and panendoscopy or bronchoscopy will be performed if needed. After 3 years, patients will be followed by conventional follow-up.
干预措施: injected CT-scan (Other)
Intensive follow-up strategy
adding to the conventional follow-up strategy , an annual head&neck and thoracic injected CT-scan and Lugol upper gastrointestinal endoscopy (the first performed 12 months after inclusion), annual whole body PET-CT (the first at 6 months after inclusion). These 3 exams are performed every year during 3 years after inclusion (i.e. 3 CT-scan, 3 digestive endoscopies and 3 PET-CT per patient). Clinical follow up will be conducted as in the conventional follow up group and panendoscopy or bronchoscopy will be performed if needed. After 3 years, patients will be followed by conventional follow-up.
干预措施: whole body PET-CT (Other)
Intensive follow-up strategy
adding to the conventional follow-up strategy , an annual head&neck and thoracic injected CT-scan and Lugol upper gastrointestinal endoscopy (the first performed 12 months after inclusion), annual whole body PET-CT (the first at 6 months after inclusion). These 3 exams are performed every year during 3 years after inclusion (i.e. 3 CT-scan, 3 digestive endoscopies and 3 PET-CT per patient). Clinical follow up will be conducted as in the conventional follow up group and panendoscopy or bronchoscopy will be performed if needed. After 3 years, patients will be followed by conventional follow-up.
干预措施: Lugol upper gastrointestinal endoscopy (Procedure)
Intensive follow-up strategy
adding to the conventional follow-up strategy , an annual head&neck and thoracic injected CT-scan and Lugol upper gastrointestinal endoscopy (the first performed 12 months after inclusion), annual whole body PET-CT (the first at 6 months after inclusion). These 3 exams are performed every year during 3 years after inclusion (i.e. 3 CT-scan, 3 digestive endoscopies and 3 PET-CT per patient). Clinical follow up will be conducted as in the conventional follow up group and panendoscopy or bronchoscopy will be performed if needed. After 3 years, patients will be followed by conventional follow-up.
干预措施: Biopsy (Procedure)
结局指标
主要结局
Overall Survival
时间窗: Up to 5 years
次要结局
未报告次要终点