2023-509465-20-00招募中3 期
TIming of start of systemIc treatment for asymptomatic MEtastasized PANcreatic cancer (TIMEPAN): a prospective multicenter patient preference cohort
Amsterdam UMC14 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2024年10月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 184
- 试验地点
- 14
- 主要终点
- Quality Adjusted Overall Survival
研究概览
简要总结
To assess the effect of immediate versus delayed start of chemotherapy on quality adjusted overall survival in patients with metastatic pancreatic cancer.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).
- •No prior chemotherapy for metastatic disease (patients might have received adjuvant treatment more than 6 months before the development of metastatic disease, or neoadjuvant treatment before surgery for resectable disease)
- •Patients with histologically/cytological confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma.
- •Measurable disease on computed tomography (CT) scan per RECIST version 1.1 criteria.
- •Eastern Cooperative Oncology Group Performance Status of 0-1
- •Life expectancy ≥ 3 months.
- •Age ≥ 18 years
- •A negative urine or serum pregnancy test within 7 days before Day 1 (first dose of study medication) if female subject is of childbearing potential.
- •Screening clinical laboratory values as follows: a. Absolute neutrophil count > 1.5 x 109 /L b. Total bilirubin ≤ 1.5 times upper limit of normal (ULN). c. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times ULN, (if liver metastases are present, then ≤ 5 times ULN is allowed). d. Serum creatinine < 1.5 x ULN or creatinine clearance >50 mL/min/1.73 m2 e. Prothrombin time/international normalized ratio within normal limits (± 15%) or within therapeutic range if subject takes warfarin. Partial thromboplastin time (PTT) within normal limits (± 15%). f. Platelet count > 100,000 x 109 /L
- •No symptoms related to advanced disease, specified as: a. no pain requiring regular narcotic analgesics; b. no weight loss over 5 kg (unless related to surgery or other illness); c. no persistent nausea requiring medication; d. no obstructive bowel symptoms; e. no persistent fever related to metastatic cancer; f. no other symptom which in the opinion of the clinician was due to progressive metastatic cancer.
排除标准
- •Known central nervous system involvement or brain metastases.
- •New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months
- •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.
- •Inability to comply with study and follow-up procedures as judged by the Investigator.
- •Women currently pregnant or breastfeeding.
结局指标
主要结局
Quality Adjusted Overall Survival
Quality Adjusted Overall Survival
次要结局
- Time to disease progression after inclusion (Restricted mean progression free survival (RM-PFS): area under the Kaplan-Meier PFS curve between inclusion and maximum follow-up of the study, estimated 12 months)
- Quality adjusted Progression Free Survival (PFS)
- Overall survival (in months)
- Duration of time without symptoms of disease progression or toxicities (TWiST)
- Adverse events according to NCI CTC version 5.0
- Change in CA 19.9
研究者
Marc Zuurbier
Scientific
Amsterdam UMC
研究点 (14)
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