NCT01864772已完成2 期
Phase II Multicenter Trial Evaluating First Line Carboplatin, 5-Fluorouracil and Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer, Aged 70 and Over, Ranked as Fit (no Frailty) by Geriatric Assessment
Groupe Oncologie Radiotherapie Tete et Cou2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2013年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Objective response and acute toxicity
研究概览
简要总结
The aim of the trial is to evaluate the clinical benefit (efficacy, safety, preservation of autonomy) of cetuximab-carboplatin-5FU combination as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma in patients over 70 years without frailty (after geriatric assessment).
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 70 years
- •patient enrolled in ELAN-ONVOCAL study and evaluated as fit (harmonious aging) by GERICO screening method for geriatric frailty
- •life expectancy superior to 12 weeks
- •creatinin clearance > ou equal to 50ml/mn calculated using Modification of Diet in Renal Disease (MDRD) formula
- •hematologic function : absolute neutrophil count > 1.5 x 10^9/l, platelets > 100 x 10^9/l, hemoglobin > 9,5 g/dl
- •liver function : total bilirubin inferior to 1,25 x Upper limit of normal (ULN), SGOT/SGPT inferior to 5 x ULN, PAL inferior to 5 x ULN
- •The disease:
- •histologically proven head and neck squamous cell carcinomas
- •recurrent or metastatic. Visceral metastases or locoregional recurrence unsuitable for curative locoregional treatment: unsuitable for primitive tumor surgery due to local extension (evidently authorized for lymph nodes) and unsuitable for radiotherapy for primitive tumor (or already performed) due to metastatic dissemination and the absence of indication for re-irradiation of primitive tumor.
- •Presence of at least one measurable lesion (defined by RECIST criteria) by CT scan or IRM
- •asymptomatic cerebral metastases authorized
- •signed Informed Consent Form
- •affiliated to the French social security system (or a beneficiary of this system) according to the provisions of the law of 9 August 2004
排除标准
- •Previous systemic chemotherapy, except for chemotherapy as part of multimodal treatment for locally advanced cancer completed more than 6 months prior to study enrollment
- •Known contraindication specific to one of study treatments (particularly cardiac for 5FU)
- •Known dihydropyrimidine dehydrogenase deficiency (DPD deficiency).
- •Patients considered as "unfit " (fragile) by GERICO screening method for geriatric frailty
- •Irradiation within 4 weeks prior to study enrollment.
- •Nasopharyngeal, rhinopharyngeal or maxillary sinus carcinoma.
- •Presence of infection (infection requiring intravenous antibiotics), including tuberculosis and HIV infection (human immunodeficiency virus).
- •Concomitant treatment with other antitumor immunotherapy or hormonal therapy.
- •Other antitumor concomitant therapies.
- •Prior treatment with EGFR-targeted therapy (epidermal growth factor receptor).
- •Treatment with one of study drugs within 30 days prior to study enrollment.
- •Presence of documented symptomatic brain or leptomeningeal metastases
- •Clinically significant coronaropathy or antecedent myocardial infarction within 12 months prior to study enrollment or high-risk uncontrolled arrhythmias or uncontrolled heart failure.
- •Medically uncontrolled arterial hypertension
- •Other prior or concomitant cancer, with exception for carcinoma in situ of the uterine cervix, or for cutaneous basal cell carcinoma within 5 years prior to study enrollment.
- •Presence of medical or physiological factors susceptible to modify patient compliance with study protocol and follow-up or Informed Consent Form signing.
- •Known allergy or hypersensibility to monoclonal antibodies (bevacizumab, cetuximab), or to other chemotherapies of the study or to their excipients
研究组 & 干预措施
Carbo, 5FU, Cetuximab
Experimental
6 cycles (1 cycle = 21 days) of: carboplatin AUC 5, 5FU D1-4 1000mg/m²/d, every 21 days cetuximab weekly (400 mg/m² the first week of treatment and then 250 mg/m²/w)
Maintenance by cetuximab 500 mg/m² every 2 weeks until progression or toxicity
干预措施: Carbo, 5FU, Cetuximab (Drug)
结局指标
主要结局
Objective response and acute toxicity
时间窗: 1 month after the end of chemotherapy
Objective tumor response at 12 weeks, safety (no grade 3, 4, 5 toxicities) and preservation of geriatric autonomy (absence of 2 or more points decrease on the Activities of Daily Living (ADL) scale) 1 month after the end of chemotherapy
次要结局
- Best objective tumor response(6 weeks after the end of treatment)
- Overall survival(1 year after the end of treatment)
- progression free survival(1 year after the end of treatment)
- Duration of response under cetuximab maintenance therapy(1 year after the end of maintenance)
- Toxicity of cetuximab maintenance therapy(3 months after the end of maintenance)
- autonomy(1 month after the end of treatment)
- Health related quality of life(1 month after the end of chemotherapy)
研究者
研究点 (2)
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