Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial
United States125 participantsStarted 2018-06-21
Plain-language summary
This is an open-label, phase II study in patients with resectable and borderline resectable pancreas cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA
* Be 18 years of age or older.
* Be able to understand and provide written informed consent or have a legally authorized representative (LAR).
* Have an Eastern Cooperative Group (ECOG) performance status \< 2 (please see the appendix).
* Have documentation of histologically confirmed adenocarcinoma. Biopsy must have been completed prior to start of treatment; additional biopsy is not required for the study.
* Have clinical stage consistent with resectable or borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings.
* Have adequate organ and bone marrow function, as defined by:
* total leukocytes \>3 x10\^3/μL.
* absolute neutrophil count (ANC) \>1.5x 10\^3/μL.
* hemoglobin \>9 g/dL.
* platelets \>100 x 10\^3/μL.
* creatinine clearance \>60 mL/min or creatinine \<1.5 mg/dL; bilirubin \< 2 mg/dL.
* aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) \<3 x upper limit of normal (ULN). At two weeks from biliary decompression, if the subject's serum AST/ALT remains greater 3x ULN, but has demonstrated a progressive decline, the subject may be enrolled into the trial and appropriate modification and dose adjustments will be made to the assigned regimen. Eligibility of subjects whose AST/ALT remain elevated 3x ULN, without demonstrating a downward trend, will be determined at the discretion of the trial principal investigators.
* Subjects must be CA19-9 producers as defined by a pretreatment CA 19-9 \> 35…
What they're measuring
1
Completion of all intended neoadjuvant therapy and surgical therapy
Timeframe: Five years.
Trial details
NCT IDNCT03322995
SponsorMedical College of Wisconsin
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-06-01
Contact for this trial
Medical College of Wisconsin Clinical Cancer Center