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:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-24 @ 6:32 PM
NCT ID:
NCT04452357
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically or cytologically-confirmed pancreatic adenocarcinoma.
* Patients must have non-metastatic pancreatic cancer not appropriate for immediate surgical resection. This includes the following:
* Any involvement (defined as loss of fat plane on contrast CT) of any of the following vessels\*:
* Common hepatic artery
* Superior mesenteric artery
* Celiac axis
* Superior mesenteric vein
* Portal vein
* Aorta
* These criteria will be judged by the operating surgeon in conjunction with a radiologist prior to enrollment.
* Poor performance status not immediately conducive to radical surgery
* Other clinical reasoning by the treating physicians that supports pre-operative chemoradiation
* Patients must have evaluable disease as measured by RECIST 1.1 criteria.
* Planned surgical resection at the time of enrollment (may be initially staged as resectable, borderline resectable, or locally-advanced/unresectable).
* Eastern Cooperative Oncology Group, or ECOG, performance status 0-2.
* Adequate bone marrow, hepatic, renal function.
* ANC ³ 1,500/ml and PLT ³ 100,000/ml
* Bilirubin less than 1.5 ULN
* AST and ALT \< 3X ULN
* Serum Creatinine \<1.5X ULN
* Prior chemotherapy allowed, but not mandatory. Patients who have undergone chemotherapy prior to participating in this study must have had a 2 week washout period at the time of signing the consent form.
* Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to registration. Postmenopausal woman must have been amenorrheic and nonlactating for at least 12 months to be considered of non-childbearing potential. Men and women of child bearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy is completed. Please refer to section 6.4 for additional detail.
* Age \> 18 years
* Participants must sign a written informed consent and HIPAA consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.
Exclusion Criteria:
* Radiological or cytologically confirmed metastatic disease
* Patients who have had any prior therapy for pancreatic cancer, except chemotherapy (see 6.1.7)
* Concurrent non-study chemotherapy or biologic therapy
* A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
* Scleroderma or active connective tissue disease
* Active inflammatory bowel disease
* Serious, active infections requiring treatment with IV antibiotics
* Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04452357
Study Brief:
Protocol Section:
NCT04452357