Pancreatic Adenocarcinoma Neoadjuvant Chemotherapy Before Surgery
MFOLFIRINOX or Gemcitabine / Nab-paclitaxel Followed by Pancreatectomy for Patients with Borderline Resectable Pancreatic Adenocarcinoma. a Pilot Feasibility Study.
Hamilton Health Sciences Corporation
30 participants
Mar 1, 2021
INTERVENTIONAL
Conditions
Summary
This 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.
Eligibility
Inclusion Criteria7
- \. 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.
- \. Age ≤ 79 years 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 4. Normal bone marrow and organ function
- Absolute neutrophil count (ANC) = or > 1500, platelets > 100K
- Total bilirubin <1.5x upper limit of normal (ULN)
- Alanine transaminase (ALT), Aspartate aminotransferase (AST) < 3 x ULN
- Creatinine <150umol/L
- Normal prothrombin time and international normalized ratio (INR) 5. Able to provide written informed consent
Exclusion Criteria9
- Proven metastatic disease (e.g. on imaging modality such as CT scan of the chest, abdomen and pelvis or MRI)
- Locally advanced pancreatic cancer (see definition section 3.3)
- Prior treatment with radiation therapy to the pancreas or associated field.
- Contraindications to receive chemotherapy
- History of cardiac disease including congestive heart failure (New York Heart Association class 2), active coronary artery disease or uncontrolled hypertension
- Concurrent ongoing systemic infections
- Illegal substance abuse, or social conditions that may interfere with patient's participation in the trial
- Pre-existing neuropathy
- Pregnant patients
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Interventions
mFOLFIRINOX, including: Oxaliplatin 85 mg/m2 IV over 2 hours, Leucovorin 400mg/m2 IV over 2 hours, Irinotecan at 150 mg/m2 IV over 90 min, 5-Fluoruracil continuous infusion of 2400 mg/m2 IV over 46h.
Both drugs are administered once weekly for three weeks (days 1, 8, 15) followed by a week of rest (28-day cycle) for 3 cycles prior to imaging. Gemcitabine: 1000 mg/m2 intravenous infusion over 30 to 40 minutes. Nab-paclitaxel: 125 mg/m2 intravenous infusion over 30 to 40 minutes.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04452461