Pancreatic Adenocarcinoma Neoadjuvant Chemotherapy Before Surgery
Recruiting now · Phase 2
Conditions studied: Pancreatic Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT04452461
- Run by
- Hamilton Health Sciences Corporation
- People needed
- 30
- Starts
- 2021-03-01
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2024-10-10
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- 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
You may not qualify if…
- 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
Where it is running
- Juravinski Hospital — Hamilton, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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