A Phase II Study Evaluating the Rate of Cardiovascular Events During Trifluridine/Tipiracil +/- Oxaliplatin Treatment in Colorectal/Oesogastric Adenocarcinoma Patients That Have Experienced a Past Episode of Thoracic Angina-related Pain Due to Chemotherapy Including 5-fluorouracil/Capecitabine
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 11
- 主要终点
- Rate of cardiovascular events at 3 months.
研究概览
简要总结
The purpose of this study is to assess the incidence of cardiovascular events in patients with esophageal/stomach or colorectal cancer treated by trifluridine/tipiracil +/- oxaliplatin after an episode of cardiac angina-related thoracic pain due to fluoropyrimidines in the adjuvant or metastatic setting .
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 14-day screening period to determine eligibility for study entry. Patient who meet the eligibility requirement will be included in the study and will be treated by trifluridine/tipiracil +/- oxaliplatin.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •For metastatic colo-rectal-cancer, MSI and/or dMMR tumor
- •For metastatic oeso-gastric and gastric adenocarcinoma, HER+++ or HER++ FISH positive tumor
- •Left ventricular dysfunction with a left ventricular ejection fraction (LVEF) < 35% with or without an automatic implantable defibrillator,
- •Non-revascularized multivessel coronary artery disease,
- •ACS with ST elevation, and/ or troponin rise
- •QT/QTc interval > 470 ms (for women) and > 450 ms (for men) NB: Caution is required when using medicinal products with human thymidine kinase substrates, e.g. zidovudine and other drugs known to prolong the QTc interval (exhaustive list on https: //www.crediblemeds.org.")
- •Documented coronary vasospasm during 5-FU treatment leading to myocardial infarction,
- •Pregnancy and breastfeeding,
- •Treatment with any other investigational medicinal product within 28 days (4 weeks) before start of the study treatment,
- •Rare hereditary problems of galactose intolerance, the Lapp lactose deficiency, or glucose-galactose malabsorption,
- •Any other serious and uncontrolled non-malignant disease,
- •Major surgery or traumatic injury within 28 days (4 weeks) before the start of study treatment,
- •Patients with known allergy to any excipient to study drugs,
- •Bowel obstruction or inability to swallow tablets,
- •Peripheral neuropathy Grade > 1 for the oxaliplatin schedule,
- •Non resolved non-hematological toxicities from prior therapies (grade >2),
- •Abnormal values at inclusion for :
- •kalemia ;
- •Magnesemia;
- •Calcemia and corrected calcium level
- •Patient under a legal protection regime (guardianship, curatorship, judicial safeguard), or administrative decision, or incapable of giving his/her consent
- •Impossibility of submitting to the medical follow-up of the study for geographical, social reasons or psychiatric illness.
- •Patients admitted to a health or social establishment for purposes other than that of the study
研究组 & 干预措施
trifluridine/tipiracil +/- oxaliplatin
Trifluridine/tipiracil 35 mg/m² orally twice a day from day 1 to day 5 plus oxaliplatin 85 mg/m² intravenous at day 1 every 14 days.
If oxaliplatin is stopped for neurotoxicity, allergic reaction or other reason, or it is not indicated, patients will continue trifluridine/tipiracil in monotherapy 35 mg/m² orally twice a day between days 1-5 and days 8-12; repeated every 28 days.
干预措施: Trifluridine/Tipiracil (Drug)
trifluridine/tipiracil +/- oxaliplatin
Trifluridine/tipiracil 35 mg/m² orally twice a day from day 1 to day 5 plus oxaliplatin 85 mg/m² intravenous at day 1 every 14 days.
If oxaliplatin is stopped for neurotoxicity, allergic reaction or other reason, or it is not indicated, patients will continue trifluridine/tipiracil in monotherapy 35 mg/m² orally twice a day between days 1-5 and days 8-12; repeated every 28 days.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Rate of cardiovascular events at 3 months.
时间窗: At 3 months
Assessment of the rate of cardiovascular events in patients treated by trifluridine/tipiracil +/- oxaliplatin over a 3-month period.
次要结局
- Number of patients with treatment-related adverse events by CTCAE 5.0(Assessed up to 48 months)
- The 3-month drop-out rate of limiting toxicity(At 3 months)
- Number of patients with disease control rate (DCR)(Assessed up to 48 months)