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Pancreatic Adenocarcinoma Neoadjuvant Chemotherapy Before Surgery

Pancreatic Adenocarcinoma

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.

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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 Hospital
Hamilton, Ontario
Canada

Contact Study Team

Backup Contact

Pablo E Serrano, MD

[email protected]
905-521-2100
Backup Contact

Tariq Aziz, MD

Primary Contact

Leyo Ruo, MD

[email protected]
905-521-2100
Backup Contact

Christian van der Pol, MD

Backup Contact

Pablo E Serrano, MD

Backup Contact

Sameer Parpia, PhD

Backup Contact

Brandon Meyers, MD

Backup Contact

Kimmen Quan, MD

Study Sponsored By
Hamilton Health Sciences Corporation
Participants Required
More Information
Study ID: NCT04452461