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 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT02481635
Eligibility Criteria:
Inclusion Criteria:
Surgical:
* Medically fit for major pancreatic surgery
* No evidence of metastases
* No prior resection
* Arterial involvement limited to a single major vessel and is resectable
* Tumour-free margins could be achieved
* Acceptable length of vessel
* Mass considered otherwise resectable by current standards
General:
* Less than 70 years old
* Performance status \<=2
* Has pancreatic adenocarcinoma
* Adequate bone marrow and organ function
* Therapeutic heparin is allowed
* Taking chronic erythropoietin are permitted
* Not pregnant
* Agree to use contraception
* Able to provide written consent
Exclusion Criteria:
Surgical:
* Aortic involvement
* Involvement of 2 major arterial trunks
* SMV/portal venous occlusion, cannot be reconstructed
* Extensive venous involvement, no arterial involvement
* Disease progression on neo-adjuvant treatme
General:
* Concurrent cancer diagnosis
* Other malignancies unless all therapy completed, no disease for \>=3 years
* Prior radiotherapy or chemo within 1 year, to pancreas
* Bone marrow transplant/stem cell rescue
* Major surgery \<4 wks prior
* Distant metastases
* Renal dysfunction
* Pulmonary insufficiency
* History of cardiac disease
* Active systemic infection(s) or any other related illnesses
* Known HIV, HBV, HCV
* History of solid organ transplant, cardiovascular disease, inflammatory bowel disease, or underlying neuropathy
* Conditions interfering with patient participation
* Known or suspected allergy to study drugs
* Pregnant or breast-feeding
* Therapeutic coumadin
* More than or equal to Grade 2 pre-exiting peripheral neuropathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02481635
Study Brief:
Protocol Section:
NCT02481635