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 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT03138720
Eligibility Criteria:
Inclusion Criteria:
1. Patient has histologically or cytologically confirmed resectable, borderline resectable, or locally advanced (unresectable) PDAC (based upon Tempero et al 2016)
* Definition of Resectable Pancreatic Cancer includes all of the following:
* No evidence of extra pancreatic disease
* No evidence of tumor-arterial abutment (celiac, SMA \[superior mesenteric artery\] or HA \[hepatic artery\])
* If tumor induced narrowing of the SMV \[superior mesenteric vein\], PV \[portal vein\] or SMV-PV \[superior mesenteric-portal vein\] confluence is present, it must be \<50% of the diameter of the vessel
* Definition of Borderline Resectable Pancreatic Cancer
* To include at least one of the following:
* Tumor abutment \<180° of the SMA or celiac axis
* Tumor abutment or encasement of a short segment of the HA
* Tumor induced narrowing of SMV, PV or SMV-PV of \>50% of the diameter of the vessel.
* Short segment occlusion of the SMV, PV or SMV-PV with a suitable PV above and SMV below, for reconstruction
* Biopsy proven N1 disease (regional lymph nodes involved) from pre-referral biopsy or EUS-guided FNA
* Definition of Locally Advanced (Unresectable)
* Artery: Tumor encasement (\> 180°) of SMA or celiac artery
* Vein Occlusion of SMV, PV or SMV-PV without suitable vessels above and below the tumor to allow for reconstruction (no distal or proximal target for vascular reconstruction)
* No extra pancreatic disease: No evidence of peritoneal, hepatic, or extra-abdominal metastases
2. Age ≥ 18 years.
3. If a female patient is of child-bearing potential, she must have a negative serum pregnancy test (≥β-hCG) documented within 72 hours of the first administration of study drug
4. If sexually active, the patient and partner must agree to use contraception considered adequate and appropriate by the Investigator
5. Patient must have received no prior chemotherapy or radiation therapy for PDAC
6. Patients must have normal organ and marrow function as defined below:
* absolute neutrophil count ≥ 1,500/mm3
* platelets ≥ 100,000/mm3
* Hematocrit level \> 27%
* total bilirubin within institutional upper limit of normal (ULN)
* AST/ALT ≤ 2.5 × institutional ULN
* Alkaline phosphatase (AP) ≤ 2.5 x institutional ULN
* Creatinine \< 1.5 mg/dl
7. Patient has acceptable coagulation status as indicated by an INR ≤ 1.5 x ULN. Patients on anticoagulation can be included at the discretion of the investigator.
8. Karnofsky Performance Status (KPS) of ≥70%.
9. Have an elevated CA 19-9
Exclusion Criteria:
1. Patient will be excluded from this study if any of the following criteria apply: Evidence of metastatic disease. No metastatic disease defined as any one or more of the following:
* Suspicious lymphadenopathy outside of the standard surgical field (i.e. aortocaval nodes, distant abdominal nodes)
* Radiographic evidence for metastatic disease in distant organs, peritoneum, or ascites
2. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
3. Known infection with HIV, hepatitis B, or hepatitis C.
4. Has undergone major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
5. History of allergy or hypersensitivity to the study drugs.
6. Serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.
7. Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
8. Patient is unwilling or unable to comply with study procedures.
9. Patient is enrolled in any other therapeutic clinical protocol or investigational trial.
10. Patient with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.
11. Use of non-FDA approved cannabinoids are prohibited. Total daily usage of up to 40 mg per day of marinol is acceptable.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03138720
Study Brief:
Protocol Section:
NCT03138720