Phase-3 Study, Randomized, Controlled, Multi-center, Double Blind, Comparing Palliative Radiotherapy With or Without Carboplatin
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- Local progression-free survival of chemo radiotherapy compared with placebo-associated radiotherapy
研究概览
简要总结
The study population has locally advanced or metastatic bronchial or head and neck cancer.
This study assesses the value of concomitant chemo/radiotherapy with carboplatin daily during metastatic radiotherapy versus radiotherapy alone.
The realization of a systemic treatment during the radiotherapy could make it possible to obtain a benefit on the control of the evolution of the metastases and thus of the pains generated, as well as on the quality of life of the patients. In addition, a benefit in overall survival is possible.
详细描述
The study population has locally advanced or metastatic bronchial or head and neck cancer.
Patients receive 10 injections of carboplatin (validated chemo-sensitizing molecule) or placebo (glucose) before 10 radiation sessions.
The overall duration is 14 days.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with locally advanced or metastatic bronchial or head and neck cancer
- •Patient require palliative radiotherapy
- •Age ≥ 18 years
- •Obtaining the signed written consent of the patient
- •Patient affiliated to a social security scheme
排除标准
- •Other chemotherapy or targeted therapy
- •Prior radiation
- •Patients with thrombopenia < 100 000
- •Patients with neutropenia < 2000
- •Patients with renal clearance < 20 mL/min
- •Known hypersensitivity to platinum salt
- •Treatment with phenytoin or fosphenytoin
- •In previous three months, a vaccination against yellow fever, live vaccin or live attenuated vaccine
- •Unchecked diabetes
- •hemorrhagic tumor
- •Refusal of participation or inability to issue informed consent
- •Person deprived of liberty or adult under guardianship
- •Minor patients, pregnant or lactating women
- •Participation in other interventional study
研究组 & 干预措施
irradiation + carboplatin
Radiotherapy in 30 Gy en 10 fractions de 3 Gy. The overall duration to irradiation is 2 weeks Carboplatin. :10 injections 1h prior irradiation
干预措施: irradiation + carboplatin (Combination Product)
irradiation + placebo
Radiotherapy in 30 Gy en 10 fractions de 3 Gy. The overall duration to irradiation is 2 weeks Placebo :10 injections 1h prior irradiation
干预措施: irradiation + placebo (Combination Product)
结局指标
主要结局
Local progression-free survival of chemo radiotherapy compared with placebo-associated radiotherapy
时间窗: 36 months
= delay between the start date of treatment and the date of the first event related to the treated location
次要结局
- toxicity due to radiotherapy(25 months)
- Impact in quality of life(25 months)
- To evaluate free progression survival(36 months)
- evolution of dose of pain medication(25 months)
- overall survey(36 months)
- Variation in intensity of pain(25 months)