A Phase II Study, Multicenter, to Evaluate the Efficacy and Safety of the Combination of Reirradiation - Erbitux in Subjects Previously Irradiated and With a Local Recurrent Inoperable Squamous Cell Cancer of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The main objective is to evaluate the complete response rate of the association re-irradiation - Erbitux ®.
研究概览
简要总结
The purpose of this study is to investigate in patients with cancer of the throat and recurrent inoperable a different modality treatment consisting of radiation continuously for 5 weeks and half associated with a drug directed against a receptor on cell surfaces cancer, called Erbitux ®.
The investigators hope with this shorter treatment (1.5 weeks less than the usual treatment) to improve the antitumor efficacy without additional toxic side effects.
详细描述
We hope with this treatment improved antitumor efficacy without additional toxic side effects, while being shorter than 1.5 weeks of standard therapy. But this is an hypothesis we can not meet the current state of knowledge, which justifies this study.
The main hypothesis is that this combination of reirradiation and Cetuximab give a relative gain of 15% complete response rate.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with unresectable locoregional recurrence of squamous cell carcinoma in a previously irradiated area (at least 75% of the volume of recidivism must be in an area who have received at least 50 Gy)
- •The entire tumor volume can be included in a radiation field without the total dose to the spinal cord more than 50 Gy (dose + dose earlier predicted)
- •Patient with recurrent or second location in the oral cavity, oropharynx, larynx, hypopharynx, cervical lymph nodes or tissues, without distant metastases,
- •Minimum 12 months after the end of radiotherapy previous
- •WHO performance status: 0-1,
- •Evaluable disease by RECIST V.1.1.,
- •Age between 18 and 75 years
- •The patient may have received prior chemotherapy for relapse for more than five weeks,
- •The patient may have received cetuximab for the treatment of disease but not for the first relapse,
- •Hematologic function: ANC ≥ 1500/mm3, Platelets ≥ 100000/mm3,
- •Normal renal function: serum creatinine ≤ 120 µmol/l and/or creatinine clearance > 60 ml/min
- •Normal liver function: bilirubin <1.5 x ULN, alkaline phosphatase and transaminases <2.5 x ULN,
- •Normal cardiac function, assessed clinically. History of cardiovascular disease stabilized for over 12 months
- •Cons-Lack of medical indications in the proposed treatment,
- •The dosimetry of previous treatment should be available and the estimated dosimetry must be performed to check the constraints,
- •All patients of childbearing age should receive effective contraception,
- •Membership of a social security system (or be a beneficiary of such a plan) under the terms of the Act of August 9, 2004,
- •Signed informed consent
排除标准
- •Tumors of the nasal cavity and paranasal,
- •Tumors of other histological type,
- •Stage IV with distant metastases or multiple tumors,
- •Time after previous radiotherapy <12 months,
- •Less than 75% of the volume of relapse who have previously received at least 50 Gy,
- •Any medical condition or general-cons would indicate the completion of treatment. Systemic disease or uncontrolled infection,
- •History of cancer other than head and neck cancer, cutaneous basal cell, carcinoma in situ of the cervix
- •Any other concurrent anticancer therapy,
- •Patient receiving another molecule experimental
- •Pregnant, lactating or without contraception;
- •Persons deprived of liberty under guardianship
- •Inability to undergo medical test for geographical, social or psychological
- •Nasopharyngeal Neoplasms
- •Patients with active ischemic heart disease or previous myocardial infarction within the last 12 months
- •Late toxicity dermal or subcutaneous related to previous irradiation of grade> 2 in the scale CTCAE V.4.
研究组 & 干预措施
Erbitux Radiotherapy
Radiotherapy during 5 weeks and concurrent Erbitux once a week.
干预措施: Erbitux (Drug)
结局指标
主要结局
The main objective is to evaluate the complete response rate of the association re-irradiation - Erbitux ®.
时间窗: It will be measured by spiral CT scan or magnetic resonance imaging (MRI), 2 months after the end of treatment
次要结局
未报告次要终点