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Timing of start of systemlc treatment for asymptomatic MEtastasized PANcreatic cancer (TIMEPAN): a prospective multicenter patient preference cohort
EU CTIS ID: 2023-509465-20-00
What this study is testing
To assess the effect of immediate versus delayed start of chemotherapy on quality adjusted overall survival in patients with metastatic pancreatic cancer.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).
- 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)
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).
- 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)
- 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: a. Absolute neutrophil count > 1.5 x 109 /L b. Total bilirubin ≤ 1.5 times upper limit of normal (ULN). c. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times ULN, (if liver metastases are present, then ≤ 5 times ULN is allowed). d. Serum creatinine < 1.5 x ULN or creatinine clearance >50 mL/min/1.73 m2 e. 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%). f. Platelet count > 100,000 x 109 /L
- No symptoms related to advanced disease, specified as: a. no pain requiring regular narcotic analgesics; b. no weight loss over 5 kg (unless related to surgery or other illness); c. no persistent nausea requiring medication; d. no obstructive bowel symptoms; e. no persistent fever related to metastatic cancer; f. no other symptom which in the opinion of the clinician was due to progressive metastatic cancer.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.