Timing of Start of systemIc Treatment for Asymptomatic Metastasized Pancreatic Cancer

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


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.

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


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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note