Multicentric Phase II Trial: Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years Old and More Presenting Gastric Cancer Locally Advanced or Metastatic
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- 2-month Response Rate
研究概览
简要总结
The number of patients over 70 years old with cancer is increasing in France. This population is heterogenous: physiological functions, presence of co-morbidities, and autonomy can vary a lot between subjects of the same age. Physicians hesitate to treat them with optimal doses because they are afraid of the risk of toxicity in spite of the benefits of treatment. Fifty eight percent of gastric cancers are diagnosed in patients over the age of 70 in France. FOLFIRI (irinotecan, leucovorin and fluorouracil) chemotherapy appears to be a promising treatment for digestive cancer. It increases the level of response and survival without major toxicity. It becomes necessary to evaluate patients, to propose adapted treatments for their conditions.
The principal objectives are to demonstrate the efficacy of treatment, safety, survival and to find out if geriatric assessment data can help to better predict chemotherapy toxicity. The researchers plan to accrue 43 patients diagnosed with locally advanced or metastatic gastric cancer. They will receive FOLFIRI and 4 geriatric evaluations: before treatment, day 1 cycle 2, day 1 cycle 4 and at the end of chemotherapy. These evaluations include tests of cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up and Go), activities (ADL; IADL), quality of life (QLQ-C30), depression (GDS-15) and Lachs-Balducci screening.
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 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •70 years of age or older
- •Gastric cancer, locally advanced or metastatic
- •No previous adjuvant treatment (surgery, radiotherapy, chemotherapy) in the last 6 months
- •One measurable lesion
- •ECOG < 3
- •Biology and biochemistry within normal limits
- •Life expectancy > 12 weeks
排除标准
- •Other palliative chemotherapy for this cancer
- •Other cancer in the last 5 years
- •Previous treatment with irinotecan
- •Atropine treatment not possible
- •Concomitant cancer therapy except bone radiotherapy
- •Metastases to brain or meninges with symptoms
- •Other severe pathology uncontrolled
- •Problem of compliance
研究组 & 干预措施
Irinotecan associated to fluorouracil and leucovorin
On D1, as a single 90-minute intravenous infusion diluted in 250 ml of saline (sodium chloride a 9 ‰), or isotonic glucose, at a dose of 180 mg/m2. Dosage adjustments are provided in case of severe toxicity.
Then 5FU/ folinic acid: 400 mg/m2 of 5-FU as an IV bolus followed by a continuous 2400 mg/m2 infusion over 46 hours with 400 mg/m2 of folinic acid or 200 mg/m2 of l-folinic acid as a 2-hour infusion before 5-FU administration.
Doses of 5-FU are adjusted according to clinical tolerance. Resume on D15 for 6 months
干预措施: Irinotecan associated to fluorouracil and leucovorin (Drug)
结局指标
主要结局
2-month Response Rate
时间窗: 2 months
Response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0. Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).
次要结局
- Overall Survival(From date of inclusion until the date of date of death from any cause, assessed up to 12 months.)
- Progression-free Survival(From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)