2025-520735-16-00招募中2 期
Electrochemotherapy as a first line treatment in recurrent squamous cell carcinoma of the oral cavity and oropharynx: a randomized controlled trial (ECT-HN)
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 15
- 主要终点
- Superiority of electrochemotherapy treatment with bleomycin in terms of objective response compared to treatment with cetuximab + platinum-based therapy + 5-fluorouracil.
研究概览
简要总结
Superiority of the treatment of Electrochemotherapy with Bleomycin in terms of objective response compared to the treatment with cetuximab + platinum-based therapy + 5-fluorouracil
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age> 18 years;
- •Progressive disease (relapse on T and N0) in the oral cavity and oropharynx
- •Histological confirmation of head and neck squamous cell carcinoma
- •Measurable lesions suitable for applying electrical impulses
- •Performance status (Karnofsky = 70; WHO = 2)
- •Life expectancy> 3 months
- •Patients able to understand the type of treatment they will receive and able to sign informed consent
- •Patients who refuse other treatments
排除标准
- •Age<18 years;
- •Chronic renal dysfunction (creatinine> 150 µmol/L must be considered a lower administered dose of bleomycin)
- •Any severe and uncontrolled systemic illness
- •Pregnancy or lactation **; ** Pregnancy has been established before enrollment by beta-hCG on urine (pregnancy test or urinary beta-HCG) or on blood (plasma beta-hCG)
- •Other symptomatic lesions not under control;
- •Lesions not suitable for ECT (bony invasion, large vessels infiltration, etc.);
- •Injectable lesions for systemic treatment with cetuximab + platinum + 5-fluorouracil therapy
- •Acute lung infection;
- •Symptoms of poor lung function;
- •Non correctable severe coagulation disorders;
- •Previous allergic reactions to bleomycin;
- •Previous cumulative dose of 250 mg/m2 of bleomycin exceeded;
结局指标
主要结局
Superiority of electrochemotherapy treatment with bleomycin in terms of objective response compared to treatment with cetuximab + platinum-based therapy + 5-fluorouracil.
Superiority of electrochemotherapy treatment with bleomycin in terms of objective response compared to treatment with cetuximab + platinum-based therapy + 5-fluorouracil.
次要结局
- Overall survival
- Assessment of disease-free progression time between the two groups
- Evaluation of the duration of the response intended as the time from the first complete or partial response documentation to the first occurrence of disease or death progression
- Assessment of disease control,intended as complete response, partial response and stable disease, between the two groups
- Quality of life assessment (EORTC QLQ-C30, EORTC QLQ-H & N35, EQ-5D-5L) with particular attention to the effect on pain and bleeding between the two groups
研究者
Franco Ionna
Scientific
IRCCS Istituto Nazionale Tumori Fondazione Pascale
研究点 (15)
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