TIming of start of systemIc treatment for asymptomatic MEtastasized PANcreatic cancer (TIMEPAN): a randomized controlled multicenter trial - TIMEPA

Amsterdam UMC-Location AMC-dept. Internal Medicin0 个研究点目标入组 184 人开始时间: 2021年2月3日最近更新: 2021年3月22日

试验速览

暂无简介。

•1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).
•2. Patients with histologically/cytological confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma.
•3. Measurable disease on computed tomography (CT) scan per RECIST version 1.1 criteria.
•4. Eastern Cooperative Oncology Group Performance Status of 0-1
•5. Life expectancy = 3 months.
•6. Age = 18 years.
•7. No symptoms related to advanced disease.
•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 37
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 147

•1. Known central nervous system involvement or brain metastases.
•2. New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months
•3. Any other disease, active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that may render the subject at high risk for treatment complications.
•4. Inability to comply with study and follow-up procedures as judged by the Investigator.
•5. Women currently pregnant or breastfeeding.

发起方

Amsterdam UMC-Location AMC-dept. Internal Medicin