EUCTR2011-006198-25-GR进行中（未招募）1 期
A Phase II, single-arm clinical trial of administration of cisplatin and 5-fluorouracil with afatinib as first-line therapy in patients with inoperable gastric or gastroesophageal junction cancer - A-GAPP
Hellenic Cooperative Oncology Group0 个研究点目标入组 55 人开始时间: 2012年10月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients with histological or cytological diagnosis of gastric and/or gastroesophageal
- •junction adenocarcinoma/carcinoma.
- •2. Locally advanced or metastatic inoperable disease.
- •3. Life expectancy =12 weeks.
- •4. Patients who may have undergone any type of palliative treatment for localised disease, including surgical approaches and palliative radiotherapy, but not in the last four weeks before the trial.
- •5. Adequate bone marrow, hepatic and renal functional reserves (ANC=1500mm3, PLT=100mm3, GFR=50ml/min by Gault Formula, bilirubin <1.5x, AST/ALT <2.5x upper normal limit or 5x in the presence of hepatic metastases).
- •6. Patients must be able to swallow pharmaceutical tablets and to be eligible to receive intravenous chemotherapy.
- •7. Men or women patients must be at least 18 years old.
- •8. Performance Status Scale 0 or 1 (ECOG).
- •9. Measurable disease according to RECIST 1.1.
- •10. Left ventricular ejection fraction (LVEF) =50% (ECHO or MUGA).
- •11. Provision of patient informed consent for participation in the study and for the use of biological material for research purposes.
- •12. Willingness and ability to comply with scheduled medical visits, therapeutic treatment programmes, laboratory testing and other study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •1. Previous systemic first-line therapy.
- •2. Previous therapy with EGFR/HER TKI or other experimental agent.
- •3. Diagnosis of a second malignancy, except basal cell carcinoma of the squamous epithelium or in situ carcinoma of any organ, for which an appropriate treatment
- •has been administered without indications of relapse for 12 months.
- •4. Presence of uncontrolled, active brain metastases (controlled brain metastases
- •are considered those that have been irradiated and have remained stable for at
- •least 4 weeks after radiation therapy).
- •5. Diagnosis of spinal cord compression or carcinomatous meningitis.
- •6. Any of the following that has occurred within 12 months before the start of
- •the study treatment: myocardial infarction, serious or unstable angina pectoris, aortic-coronary or peripheral bypass surgery, symptomatic heart failure, vascular stroke, or transient ischemic attack, or pulmonary embolism.
- •7. Continuing grade =2 heart rate abnormalities; atrial fibrillation of any grade.
- •8. Hypertension uncontrolled by medication treatment (>150/100 mm/Hg despite
- •the administration of best medical therapy).
- •9. In the case of previous irradiation of locally advanced disease, absence of measurable tumor sites outside the irradiation field.
- •10. Presence of any other disease which in the opinion of the doctor responsible constitutes a contraindication for the administration of cisplatin, 5FU or afatinib.
- •11. Diagnosed human immunodeficiency virus (HIV) or disease associated with Acquired Immunodeficiency Syndrome (AIDS).
- •12. Pregnancy or lactation. Female patients must be surgically sterilised, menopausal, or must consent to use effective contraception throughout the course of the trial.
- •All female patients with reproduction ability must undergo a pregnancy test (serum or urine). The effective contraceptive technique will be determined by the
- •main investigator or a person authorized by the investigator.
- •13. Any other serious, acute or chronic, medical or psychiatric condition or laboratory analysis finding which, in the investigator’s opinion, could create
- •excessive danger as regards the patient’s participation in the trial or administration of the trial medication may render a patient ineligible for inclusion in the trial.
研究者
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