EUCTR2018-004119-36-NO进行中（未招募）1 期
Altered tumor oxygenation by Metformin, a potential step in overcoming radiotherapy resistance in locally advanced cervical cancer.
Oslo University Hospital0 个研究点目标入组 90 人开始时间: 2019年6月24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
- 90
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
入选标准
- •Histologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma)
- •Planned for radical chemoradiotherapy
- •Included in the MIMB-protocol
- •Over 18 years
- •Speaks and understands Norwegian
- •Cervical tumor available for biopsy by gynecological examination
- •Able to receive weekly cisplatin
- •Able to take oral medication
- •Ability to understand and willing to sign a written informed consent
- •Willing to undergo biopsies of cervical tumor
- •Willing to be included in the Embrace 2- protocol if randomized to the control group
- •Negative pregnancy test in women with childbearing potential
- •Normal bone marrow and organ function = 14 days before inclusion
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •Evidence of distant metastasis. Suspicious paraaortic lymphnodes below the renal wessel is allowed if they are covered by the radiation field
- •Patients who have received other cancer treatments for their cervical cancer
- •Patients who receive other experimental drugs
- •Known diabetes mellitus
- •Currently taking Metformin or any other antidiabetic drugs (sulfonylureas, thiazolidinediones, insulin)
- •History of allergic reaction attributed to compounds of similar chemical or biologic composition to metformin
- •Any condition associated with increased risk of metformin- induced lactic acidosis (congestive heart failure defined as New York Heart Association (NYHA) class III or IV functional status, history of acidosis of any kind)
- •Uncontrolled intercurrent somatic illness including, but not limited to, ongoing or active serious infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction within 6 months and cerebrovascular disease with previous stroke
- •Psychiatric illness /social situations limiting study compliance
- •Prior radiotherapy to the pelvis
- •Already on medication with increased risk of lactic acidosis
- •Patients who are pregnant or breastfeeding are excluded due to risk of teratogenic and abortifacient effects of radiotherapy and cisplatin, and the potential risk of adverse effect of nursing infants
- •Patients with other invasive malignancies except non-melanoma skin cancers
- •Known HIV-positive patients on antiretroviral therapy
- •Known conditions limiting absorption of study drug (bowel obstruction, malabsorption syndromes)
- •Patients taking the drug disulfiram (antabus)
研究者
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