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 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT01985958
Eligibility Criteria:
Inclusion Criteria:
* Histological or cytological diagnosis of pancreatic carcinoma
* Patients ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status 0,1,or 2
* Patients must have distant metastatic disease (stage 4)
* Satisfactory organ and bone marrow function as defined by: Absolute neutrophil count\> 1,000/uL, Platelets \> 75,000uL Hemoglobin \> 9 Bilirubin ≤ 2.0x the institutional normal upper limit unless secondary to bile duct obstruction by tumor,
* Creatinine ≤ 1.5x the institutional normal upper limit
* Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5x the institutional normal upper limit.
* A clinical recommendation for radiotherapy to the primary or a metastatic lesion had been made.
* Must be able to provide informed consent.
Exclusion Criteria:
* No prior radiation to the area planned for radiotherapy
* Active invasive cancer other than pancreatic adenocarcinoma. Non-melanoma skin cancer, superficial cervical or bladder cancer and prostate cancer with PSA level \< 1.0 are not excluded.
* Known HIV, HCV and/or HBV positive (by patient report/medical record)
* Patients with ongoing or active infection
* Planned concurrent treatment with systemic high dose corticosteroids.
* Received an anticancer treatment (systemic therapy or radiation therapy)within 21 days prior to enrollment.
* Immunotherapy (e.g. monoclonal antibodies)within 21 days prior to enrollment.
* Immunosuppressive therapies (e.g. steroids, cyclosporine) are not permitted.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01985958
Study Brief:
Protocol Section:
NCT01985958