Pancreatic Adenocarcinoma Neoadjuvant Chemotherapy Before Surgery
Pancreatic AdenocarcinomaThis is a single-arm, single-center feasibility trial of patients with borderline resectable pancreatic adenocarcinoma receiving chemotherapy with mFOLFIRINOX or gemcitabine / nab-paclitaxel followed by pancreatectomy.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 to 79
Participation Criteria
Inclusion Criteria:
* 1. Men and women 18 years of age or older who present with biopsy proven borderline resectable pancreatic adenocarcinoma who are medically fit for surgery as per assessment by treating surgeon.
2. Age ≤ 79 years 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 4. Normal bone marrow and organ function
1. Absolute neutrophil count (ANC) = or \> 1500, platelets \> 100K
2. Total bilirubin \<1.5x upper limit of normal (ULN)
3. Alanine transaminase (ALT), Aspartate aminotransferase (AST) \< 3 x ULN
4. Creatinine \<150umol/L
5. Normal prothrombin time and international normalized ratio (INR) 5. Able to provide written informed consent
Exclusion Criteria:
1. Proven metastatic disease (e.g. on imaging modality such as CT scan of the chest, abdomen and pelvis or MRI)
2. Locally advanced pancreatic cancer (see definition section 3.3)
3. Prior treatment with radiation therapy to the pancreas or associated field.
4. Contraindications to receive chemotherapy
5. History of cardiac disease including congestive heart failure (New York Heart Association class 2), active coronary artery disease or uncontrolled hypertension
6. Concurrent ongoing systemic infections
7. Illegal substance abuse, or social conditions that may interfere with patient's participation in the trial
8. Pre-existing neuropathy
9. Pregnant patients
Study Location
Juravinski Hospital
Juravinski HospitalHamilton, Ontario
Canada
Contact Study Team
Tariq Aziz, MD
Christian van der Pol, MD
Pablo E Serrano, MD
Sameer Parpia, PhD
Brandon Meyers, MD
Kimmen Quan, MD
- Study Sponsored By
- Hamilton Health Sciences Corporation
- Participants Required
- More Information
- Study ID:
NCT04452461