Status:
RECRUITING
Pancreatic Adenocarcinoma Neoadjuvant Chemotherapy Before Surgery
Lead Sponsor:
Hamilton Health Sciences Corporation
Conditions:
Pancreatic Adenocarcinoma
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Borderline resectable pancreatic adenocarcinoma infiltrates into adjacent vascular structures to an extent such that complete macroscopic resection is technically feasible, but an R0 resection poses a...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04452461
Start Date
March 1 2021
End Date
May 1 2026
Last Update
October 10 2024
Active Locations (1)
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1
Juravinski Hospital
Hamilton, Ontario, Canada, L8V1C3