Phase III Study Comparing Maintenance With Pemetrexed or Gemcitabine to a Surveillance in Elderly Patients (70 Years Old and More) With a Advanced Non Small Cell Lung Cancer Controlled by Induction Chemotherapy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 632
- 试验地点
- 77
- 主要终点
- Overall survival
研究概览
简要总结
For elderly patient, the treatment of Non Small Cell Lung Cancer was based on monotherapy but IFCT-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and paclitaxel) is better than monotherapy in term of overall survival and progression free survival. The current recommendations are now to administer a carboplatin based bitherapy (4 or 6 cycles). After the treatment is stopped until progression and initiation of a second line treatment. The risk of this strategy is to be confronted to a rapid disease progression during the free interval. Indeed, about 1/3 of the patients whose disease was controlled after the chemotherapy do not receive 2nd line. The concept of maintenance is based on a continuous therapeutic pressure in order to preserve the therapeutic profit obtained by the treatment of 1st line (induction chemotherapy).
There is two types of maintenance :
- continuous maintenance therapy which consists in continuing the treatment initially associated with platinum until disease progression.
- switch maintenance which consists in introducing a new treatment after the end of induction chemotherapy The two types are validated by several trials. The marketing authorization of pemetrexed was enlarged to maintenance for non squamous carcinoma.
Gemcitabine has a good tolerance profile which make possible the use in a maintenance strategy. Several trials evaluated maintenance with this product and some show benefits in term of progression free survival.
The objective of this trial is to evaluate the switch maintenance in elderly patient with a controlled disease after 4 cycles of chemotherapy carboplatin-paclitaxel.
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
- None
入排标准
- 年龄范围
- 70 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically documented Non Small Cell Lung Cancer non resectable or non irradiable stage III or stage IV
- •EGFR wild type or non feasible EGFR
- •90 >Age ≥ 70
- •ECOG Performance status : 0, 1 or 2
- •Mini-Mental Test Status (MMS) > 23
排除标准
- •Mixed non-small cell and small cell tumors
- •Patients with EGFR mutated tumor
- •Patient with EML4-ALK translocation
- •Evolutive or symptomatic metastasis of central nervous system
- •Superior vena cava syndrome
- •Calcemia > 2,70 mmol/L
研究组 & 干预措施
Surveillance
干预措施: Induction chemotherapy (Drug)
Maintenance
Pemetrexed for non squamous NSCLC Gemcitabine for squamous NSCLC
干预措施: Pemetrexed (Drug)
Maintenance
Pemetrexed for non squamous NSCLC Gemcitabine for squamous NSCLC
干预措施: Gemcitabine (Drug)
Maintenance
Pemetrexed for non squamous NSCLC Gemcitabine for squamous NSCLC
干预措施: Induction chemotherapy (Drug)
结局指标
主要结局
Overall survival
时间窗: Up to 15 months
次要结局
- 2nd line overall survival(Up to 7 months)
- 2nd line progression free survival(Up to 4 months)
- Number of adverse events(Up to 7 months)
- Feasibility of treatment (number of cycles of maintenance)(84 days on average)
- Progression free survival(up to 7 months)
- Number of patient with at least one adverse event(up to 7 months)
- response and stabilisation duration(up to 7 months)
- 2nd line response rate(Up to 4 months)
- Treatment duration(Up to 7 months)