MFOLFIRINOX or Gemcitabine / Nab-paclitaxel Followed by Pancreatectomy for Patients with Borderline Resectable Pancreatic Adenocarcinoma. a Pilot Feasibility Study.

Trial ID: NCT04452461

Interventional - Phase 2 - Recruiting

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.

Conditions

Pancreatic Adenocarcinoma

Interventions

mFOLFIRINOX
Gemcitabine / Nab-paclitaxel

Eligibility

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

Sponsor

Hamilton Health Sciences Corporation

Source: ClinicalTrials.gov

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