Clinical Trials

Title   Celgene HEOR-PANC-ABX-USA-0804161
Principal Investigator/ Physician   Thomas W. Butler, MD
Protocol┬áNo.   0804161
Open Date   11/30/2017
Gender   Both
Cancer Site   Pancreatic
Status   Open
Sponsor   Celgene
Contact Email   MCI Clinical Trials

Protocol Title:  "A Prospective Quality of Life Study in Metastatic Pancreatic Cancer"


Inclusion Criteria:  Aged ≥ 18 years; Able to read, comprehend, and complete questionnaires and interview in English; Has access to an internet-connected computer/ tablet/ smart-phone; Has clinician-confirmed diagnosis of metastatic (not locally advanced) adenocarcinoma of the pancreas; Treatment: Patient is receiving either Abraxane plus gemcitabine (A/G) or FOLFIRINOX (FFX) as a first line therapy for metastatic pancreatic cancer (may include modified FFX or A/G); Stage of treatment: Patient has not been on therapy for more than one month (i.e, 3 doses of Abraxane; or 2 doses of fluorouracil [5 FU]) (you may include patients who are due to start therapy within the next 6 weeks); Written informed consent given prior to any study-related procedures


Exclusion Criteria:  Has a mental or physical condition that would prevent completion of questionnaires or participation in interviews; Pancreatic cancer has metastasized to the brain; Has another primary malignancy with the exception of: squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, uteri, nonmelanomatous skin cancer, carcinoma in-situ of the breast, or incidental histological finding of prostate cancer (TNM stage of T1a or T1b); Currently enrolled in any other cancer-related interventional study or quality of life (QOL) study (registry studies and post-marketing safety studies are permitted);  Documented history in the past 12 months of alcohol or other substance abuse

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