New and Emerging Therapies for the Treatment of Resectable, Borderline Resectable, or Locally Adv… (NCT04481204) | Clinical Trial Compass
WithdrawnPhase 2
New and Emerging Therapies for the Treatment of Resectable, Borderline Resectable, or Locally Advanced Pancreatic Cancer, PIONEER-Panc Study
Stopped: 0 participants
0Started 2023-04-18
Plain-language summary
This is a phase II study using the Bayesian platform design. There are three clinical stage groups of localized pancreatic cancer: resectable, borderline resectable, and locally advanced disease. Each stage group will have a defined standard of care chemotherapy regimen for a control arm, serving as a basis of comparison. Each group may have one or more experimental arms. Experimental arms may be added to the platform over time, and the effects of the experimental treatments will be tested against the controls for each group.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* TREATMENT NAIVE RESECTABLE PDAC COHORT: Pathologically proven adenocarcinoma of the pancreas by cytology or biopsy
* TREATMENT NAIVE RESECTABLE PDAC COHORT: Confirmation of clinical stage of resectable
* TREATMENT NAIVE RESECTABLE PDAC COHORT: No prior chemotherapy or radiation therapy for PDAC
* TREATMENT NAIVE RESECTABLE PDAC COHORT: No current use of immunosuppressive medication
* TREATMENT NAIVE RESECTABLE PDAC COHORT: Not pregnant and not nursing, for women of childbearing potential, a negative urine or blood pregnancy test done =\< 7 days prior to registration is required
* TREATMENT NAIVE RESECTABLE PDAC COHORT: Life expectancy greater than 6 months
* TREATMENT NAIVE RESECTABLE PDAC COHORT: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* TREATMENT NAIVE RESECTABLE PDAC COHORT: Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* TREATMENT NAIVE RESECTABLE PDAC COHORT: Platelet count \>= 100,000/mm\^3
* TREATMENT NAIVE RESECTABLE PDAC COHORT: Creatinine =\< 1.5 x upper limit of normal (ULN)
* TREATMENT NAIVE RESECTABLE PDAC COHORT: Calculated (Calc.) creatinine clearance \> 45 mL/min
* TREATMENT NAIVE RESECTABLE PDAC COHORT: Total bilirubin =\< 2.0 mg/dL
* TREATMENT NAIVE RESECTABLE PDAC COHORT: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)
* TREATMENT NAIVE RESECTABLE PDAC COHORT: Hemoglobin \>= 8.0 mg/dL
* PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Pathologically proven a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.