Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Early Stage Pancreatic Cancer: A Multicentre Randomised Study (DYNAMIC- Pancreas)

Australasian Gastro-Intestinal Trials Group0 个研究点目标入组 118 人开始时间: 2018年3月6日最近更新: 2023年6月26日

适应症

试验速览

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•1. Subjects who have undergone complete macroscopic resection for adenocarcinoma of the pancreas (R0 or R1 resection) with curative” intent.
•2. A representative tumour sample is available for molecular testing within 6 weeks after surgery.
•3. Subjects is fit for adjuvant chemotherapy.
•4. Subject has ECOG performance status 0-2.
•5. Subject is to attend for administration of adjuvant therapy.
•6. Subject is accessible for follow up.
•7. No evidence of malignant ascites, liver metastasis, spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs - Subject to have had a CT chest/ abdomen/ pelvis scan within 12 weeks prior to randomisation.
•8. Fully informed written consent given

•1. History of another primary cancer within the last 3 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix.
•2. Patient has inadequate organ function:
•a. Moderate/severe renal impairment (GFR<30 ml/min), as calculated by the Cockcroft and Gault equation
•b. Absolute neutrophil count <1.0x109/L
•c.Platelet count <75x109/L
•d.Haemoglobin <80 g/L
•e. Aspartate aminotransferase/Alanine aminotransferase >2.5 x upper limit of normal
•3. Patient has a medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol.
•4. Patient has TNM stage IV disease.
•5. Patient has R2 resection status.
•6. Patient has clinically significant cardiovascular disease - i.e. active or <12 months since e.g. cerebrovascular accident, myocardial infarction, unstable angina, New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension.

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