Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT01992705
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years at diagnosis.
* Biopsy proven pancreatic adenocarcinoma.
* Borderline resectable per NCCN criteria (No distant metastases, venous involvement of the portal vein/SMV, demonstrating tumor abutment and narrowing of the lumen, encasement of the portal vein/SMV without encasement of the nearby arteries, or short-segment venous occlusion resulting from either tumor thrombus or encasement but with suitable vessel proximal or distal to this area of vessel involvement, allowing for safe resection and reconstruction; gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to the celiac axis; tumor abutment of the SMA not to exceed 180 degrees of the circumference of the vessel wall.).
* Radiologically measurable or clinically evaluable disease.
* Pancreas protocol CT and/or MRI if required for further clarification of disease tissue planes within 4 weeks of registration.
* ECOG PS of 0-2.
* Able to get a Whipple resection per surgeon assessment performed within 4 weeks of registration.
* The following laboratory values obtained ≤ 28 days prior to registration:
* Absolute neutrophil count (ANC) ≥ 1,500/mm3.
* Platelet count ≥ 100,000/mm3.
* Hemoglobin \> 8.0 g/dL.
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
* SGOT (AST) ≤ 2 x ULN.
* SGPT (ALT) ≤ 2 x ULN.
* Creatinine ≤ 1.5 x ULN.
* CA 19-9 level (to establish baseline).
* A negative pregnancy test within 7 days prior to registration for women of childbearing potential. In addition, male and female participants must commit to adequate contraception while on study.
* Able to provide written informed consent.
* Willing to return for all required study assessments.
* Neurological assessment for pre-existing peripheral neuropathy.
* Documentation of pre-existing hearing deficits.
Exclusion Criteria:
* Any pancreatic adenocarcinoma that does not meet criteria for borderline resectable disease.
* Prior history of abdominal radiation therapy.
* History of autoimmune disease such as scleroderma, lupus, and inflammatory bowel disease.
* Patients with tumor-caused symptomatic bowel obstruction.
* Chemotherapy (including hormonal therapy) within the past 5 years from date of registration.
* Other invasive malignancies within the past 5 years from date of registration.
* Pregnant or nursing women or women of childbearing age that are unwilling to employ adequate contraception.
* Other co-morbid conditions which, based on the judgment of the physicians obtaining informed consent, would make the patient inappropriate for this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01992705
Study Brief:
Protocol Section:
NCT01992705