Trial purpose
Cancer treatment
Tumor type
Upper gastrointestinal tract
Age
18+
Trial acronym
DYNAMIC-Pancreas
Clinical summary
Summary
All participants in this study will have blood drawn during week 4 and week 8 post-surgery for circulating tumour DNA analysis. They will then be randomly allocated to one of two treatment groups, where the choice of chemotherapy regimen will be made prior to randomisation. Patients are eligible to join this trial if they are at least 18 years old, have undergone curative surgery for localised pancreatic cancer and have been recommended adjuvant chemotherapy
Conditions
This trial is treating people with pancreatic cancer
Eligibility
Inclusion
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
Exclusion
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.
Inclusion
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Walter and Eliza Hall Institute
Scientific Title
Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Early Stage Pancreatic Cancer: A Multicentre Randomised Study
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