Timing of Start of systemIc Treatment for Asymptomatic Metastasized Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Apr 22, 2024
  • participants needed
    184
  • sponsor
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Updated on 31 May 2021

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.

Details
Condition Metastatic Pancreatic Cancer, Metastatic Pancreas Cancer
Treatment FOLFIRINOX
Clinical Study IdentifierNCT04897854
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Last Modified on31 May 2021

Eligibility

Yes No Not Sure

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
Absolute neutrophil count > 1.5 x 109 /L
Total bilirubin 1.5 times upper limit of normal (ULN)
Aspartate aminotransferase and alanine aminotransferase 2.5 times ULN, (if liver metastases are present, then 5 times ULN is allowed)
Serum creatinine < 1.5 x ULN or creatinine clearance >50 mL/min/1.73 m2
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%)
Platelet count > 100,000 x 109 /L
No symptoms related to advanced disease, specified as
no pain requiring regular narcotic analgesics
no weight loss over 5 kg (unless related to surgery or other illness)
no persistent nausea requiring medication
no obstructive bowel symptoms
no persistent fever related to metastatic cancer
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
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