EUCTR2017-004877-15-BE进行中（未招募）1 期
Randomised phase II trial of definitive radiotherapy with or without metformin in patients with inoperable stage III non-small cell lung cancer - RADFORMI
Antwerp University Hospital, Department Thoracic Oncology0 个研究点目标入组 104 人开始时间: 2018年3月19日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 104
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. Provision of signed and dated informed consent form.
- •2. Stated willingness to comply with all study procedures and availability for the duration of the study.
- •3. Ability to take oral medication and willing to adhere to the RADFORMIN-regimen.
- •4. Male or female, = 18 years of age.
- •5. Histological or cytological proven stage III NSCLC after adequate staging with at least FDG-PET-CT scan, contrast enhanced CT-thorax and contrast-enhanced CT/MRI brain.
- •6. Absence of diabetes, (diabetes is defined as fasting plasma glucose >126 mg/dL or random plasma glucose >200 mg/dL).
- •7. Eastern Cooperative Oncology Group (ECOG) performance score (=WHO score) of 0-1.
- •8. Adequate hematologic, hepatic and renal function as follows:
- •a. Bone Marrow: Absolute neutrophil count ANC = 1,500/mm3 (1.5 x 109/L); White blood cells = 3,000/mm3 (3 x 109/L); Platelets = 100,000/mm3 (100 x 109/L); Haemoglobin = 9 g/dL (5.58 mmol/L).
- •b. Renal function: creatinine clearance of =50 mL/min.
- •c. Hepatic function:
- •i. AST and ALT = 2.5 x ULN
- •ii. Bilirubin: =1.5 x ULN; for subjects with Gilbert’s syndrome bilirubin > 1.5 x ULN is allowed if no symptoms of compromised liver function are present
- •9. Adequate pulmonary function in order to be administered definitive radiotherapy. With Forced Expiratory Volume (FEV) > 1.2 litres per second or more than 50% of predicted, and DLCO > 40% predicted. (Values without administration of medical bronchodilation. In case of Tiffeneau < 70% bronchodilation will be administered)
- •10. Having received at least 2 cycles of platinum-based chemotherapy. This according to institutional standards and without progression (on a restaging CT-scan within 3 weeks after day 1 of the last given cycle, according to RECIST criteria).
- •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 41
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 63
排除标准
- •1. Current use of metformin, insulin or other oral antidiabetic drugs (thiazolidinediones, sulfonylureas, metiglinides, alpha-glucosidase inhibitors, incretin mimitics, dipaptidyl peptidase-4 inhibitors, amylin analogues, SGLT-2-inhibitors) for any reason.
- •2. Evidence for metastatic disease.
- •3. Conditions associated with increased risk of metformin-associated lactic acidosis: New York Heart Association class III or IV congestive heart failure, history of acidosis of any type, known kidney injury or disease, alcoholic liver disease or habitual intake of 3 or more alcoholic beverages per day.
- •4. Known pregnancy or lactating female patients.
- •5. Known allergic reactions to components of metformin.
- •6. Prior invasive malignancy within the past year (in remission, without evidence for current active disease and without maintenance therapy). Except non-melanomatous skin cancer, non-invasive carcinoma in-situ of the breast, oral cavity or cervix.
- •7. Known acquired immune deficiency syndrome.
研究者
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