Chemotherapy before surgery for borderline resectable pancreatic cancer
MFOLFIRINOX or Gemcitabine / Nab-paclitaxel Followed by Pancreatectomy for Patients with Borderline Resectable Pancreatic Adenocarcinoma. a Pilot Feasibility Study.
This study is testing whether giving chemotherapy before surgery can help people with borderline resectable pancreatic cancer and how well they can handle the treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Hamilton Health Sciences Corporation Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT04452461 on ClinicalTrials.gov |
What this trial studies
This trial investigates the feasibility of administering neoadjuvant chemotherapy using mFOLFIRINOX or gemcitabine/nab-paclitaxel to patients with borderline resectable pancreatic adenocarcinoma prior to surgical intervention. The study aims to evaluate the proportion of eligible patients enrolled and those who complete the treatment protocol, which includes chemotherapy followed by pancreatectomy. Safety analyses will be conducted after the first 15 patients complete the therapy and surgery, with follow-up assessments for disease recurrence or progression. The trial is designed to explore modifications to the treatment protocol based on patient responses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 79 with biopsy-proven borderline resectable pancreatic adenocarcinoma who are medically fit for surgery.
Not a fit: Patients with proven metastatic disease or those with locally advanced pancreatic cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and overall survival for patients with borderline resectable pancreatic adenocarcinoma.
How similar studies have performed: Other studies have shown promise with neoadjuvant chemotherapy approaches for pancreatic cancer, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hamilton, Ontario
- Juravinski Hospital — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Leyo Ruo, MD — McMaster University
- Study coordinator: Leyo Ruo, MD
- Email: ruol@mcmaster.ca
- Phone: 905-521-2100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.