Metastatic Pancreas Cancer
Conditions
Brief summary
Since patients with metastatic pancreatic cancer have a limited life expectancy, it is important to determine the timing of when to start chemotherapy in order to optimize the benefits of chemotherapy relative to the side effects. Therefore, two treatment strategies can be considered: chemotherapy started immediately at diagnosis, or delayed until disease-related symptoms occur.
Interventions
DRUGFolfirinox
In both arms the intervention will be FOLRINIOX or nab paclitaxel in combination with gemcitabine per investigator's choice
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF). * 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: 1. Absolute neutrophil count \> 1.5 x 109 /L 2. Total bilirubin ≤ 1.5 times upper limit of normal (ULN). 3. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times ULN, (if liver metastases are present, then ≤ 5 times ULN is allowed). 4. Serum creatinine \< 1.5 x ULN or creatinine clearance \>50 mL/min/1.73 m2 5. 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%). 6. Platelet count \> 100,000 x 109 /L * No symptoms related to advanced disease, specified as: 1. no pain requiring regular narcotic analgesics; 2. no weight loss over 5 kg (unless related to surgery or other illness); 3. no persistent nausea requiring medication; 4. no obstructive bowel symptoms; 5. no persistent fever related to metastatic cancer; 6. no other symptom which in the opinion of the clinician was due to progressive metastatic cancer. * 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)
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality adjusted overall survival | From date of randomization until the date of death, assessed up to 12 months | Measured in utility-per-month, using the survival in months and the monthly reported quality of life by the EQ-5D-5L questionaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to disease progression | 12 months | Restricted mean progression free survival (RM-PFS): are under the Kaplan-Meier PFS curve between randomization and follow-up of the study (estimated 12 months) |
| Overall survival | From date of randomization until the date of death, assessed up to 12 months | (In months) |
| Duration of time without symptoms of disease progression or toxicities (TWiST) | From date of randomization until the date of death, assessed up to 12 months | — |
| Number of patients with adverse events | From date of randomization until the date of death, assessed up to 12 months | According to NCI CTC version 5.0 |
| Quality adjusted progression free survival (PFS) | From date of randomization until the date of death, assessed up to 12 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Level of CA 19.9 | From date of randomization until the date of death, assessed up to 12 months | Exploratory endpoint |
Countries
Netherlands
Contacts
Primary ContactJ.W. Wilmink, Dr.
Backup ContactS. Augustinus
Outcome results
None listed