Clinical trial NCT04897854: Timing of Start of systemIc Treatment for Asymptomatic Metastasized Pancreatic Cancer
Official title: TIming of Start of systemIc Treatment for Asymptomatic MEtastasized PANcreatic Cancer (TIMEPAN): a Randomized Controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Metastatic Pancreas Cancer
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quality adjusted overall survival
timeFrame: From date of randomization until the date of death, assessed up to 12 months
Secondary outcomes:
measure: Time to disease progression
timeFrame: 12 months
measure: Quality adjusted progression free survival (PFS)
timeFrame: From date of randomization until the date of death, assessed up to 12 months
measure: Duration of time without symptoms of disease progression or toxicities (TWiST)
timeFrame: From date of randomization until the date of death, assessed up to 12 months
measure: Overall survival
timeFrame: From date of randomization until the date of death, assessed up to 12 months
measure: Number of patients with adverse events
timeFrame: From date of randomization until the date of death, assessed up to 12 months
Other outcomes:
measure: Level of CA 19.9
timeFrame: From date of randomization until the date of death, assessed up to 12 months
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord-Holland
Study officials:
References: