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

Who is this study for? Patients with Pancreatic Adenocarcinoma
What treatments are being studied? mFOLFIRINOX+Gemcitabine / Nab-Paclitaxel+Stereotactic Body Radiation Therapy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 by pancreatectomy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Juravinski Hospital
RECRUITING
Hamilton
Contact Information
Primary
Leyo Ruo, MD
ruol@mcmaster.ca
905-521-2100
Backup
Pablo E Serrano, MD
serrano@mcmaster.ca
905-521-2100
Time Frame
Start Date: 2021-03-01
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 30
Treatments
Other: Single Arm Intervention
1. Chemotherapy: 6 cycles (three months) of IV combination chemotherapy with mFOLFIRINOX on day 1 followed by one week of rest (14-day cycle). Alternatively, patients will receive three months of gemcitabine / nab-paclitaxel.~2. Re-staging CT scan with Carbohydrate Antigen (CA) 19-9 serum test.~3. Staging laparoscopy to rule out occult metastatic disease is optional based on surgeon's preference.~5\. Pancreatectomy 4 weeks following the last day of Chemotherapy as per standard of care.~6\. Adjuvant chemotherapy: as per standard of care. 7. Clinical assessment and CT scan with CA 19-9 serum test at 4-month intervals until identification of cancer recurrence.~8\. Follow up of patients after 2 years every six months for up to 5 years following the initiation of treatment will be performed off-protocol as per standard of care.
Related Therapeutic Areas
Sponsors
Leads: Hamilton Health Sciences Corporation

This content was sourced from clinicaltrials.gov