A Phase 2 interventional study of mFOLFIRINOX and Gemcitabine / Nab-paclitaxel in Pancreatic Adenocarcinoma, sponsored by Hamilton Health Sciences Corporation. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2024-10-10.
Sponsored by Hamilton Health Sciences Corporation · Phase 2, Interventional, and Treatment
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.
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 challenge when surgery is the primary therapy. Therefore, a different management strategy may be beneficial.
The primary outcome of the PANCREAS trial is defined as the proportion of eligible patients enrolled in the study over an 18-month period and the proportion of patients who complete the protocol (neoadjuvant therapy and pancreatectomy). Certain modifications of the neoadjuvant therapy protocol are expected and allowed, and the primary feasibility outcome will be one of the following: stop, main study non-feasible; continue with protocol modifications; or continue without modification. A safety analysis will be performed after first 15 patients are enrolled and complete neoadjuvant therapy and surgery. Patients enrolled in this trial will undergo interventions in the following order: neoadjuvant chemotherapy, re-staging CT scan, pancreatectomy and adjuvant chemotherapy. Postoperative mortality will be recorded up to 90 days after surgery. Patients will be followed every four months with a CT scan of the chest/abdomen for two years after resection or until evidence of disease recurrence. Patients who do not undergo surgical resection will be followed for two years after accrual (duration of study period) or until evidence of disease progression or death.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's planned enrollment of 30 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Hamilton Health Sciences Corporation is the lead sponsor of 237 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Drug: mFOLFIRINOX · Drug: Gemcitabine / Nab-paclitaxel
mFOLFIRINOX, including: Oxaliplatin 85 mg/m2 IV over 2 hours, Leucovorin 400mg/m2 IV over 2 hours, Irinotecan at 150 mg/m2 IV over 90 min, 5-Fluoruracil continuous infusion of 2400 mg/m2 IV over 46h.
Also known as: 5-FU, leucovorin, oxaliplatin
Both drugs are administered once weekly for three weeks (days 1, 8, 15) followed by a week of rest (28-day cycle) for 3 cycles prior to imaging. Gemcitabine: 1000 mg/m2 intravenous infusion over 30 to 40 minutes. Nab-paclitaxel: 125 mg/m2 intravenous infusion over 30 to 40 minutes.
Also known as: gemcitabine / abraxane
Proportion of patients eligible enrolled
Over an 18-month period The proportion of patients who complete the protocol (neoadjuvant therapy and pancreatectomy). As described, there are certain modifications of the neoadjuvant therapy protocol that are expected and allowed. The primary feasibility outcome will be one of the following: * Stop, main study non-feasible: 1) estimated proportion of eligible patients enrolled \<40% or 2) estimated proportion of enrolled patients who complete the protocol (neoadjuvant therapy and pancreatectomy) \<40%. * Continue with protocol modifications: 1) estimated proportion of eligible patients enrolled between 40-59% or 2) estimated proportion of enrolled patients who complete the protocol (neoadjuvant therapy and pancreatectomy) 40-59%. * Continue without modification: 1) estimated proportion of eligible patients enrolled equal to or greater than 60% or estimated proportion of enrolled patients who complete the protocol (neoadjuv
Time frame: 18 months
Survival
Defined as percentage of patients alive at two years from enrolment.
Time frame: 24 months
Time to Progression
Defined as the duration of time from enrolment to time to radiological evidence of disease progression or recurrence or death, whichever comes first.
Time frame: 24 months from the initiation of chemotherapy (the length of the study)
Overall Complications from surgery
Occurrence of any postoperative complication (major or minor) from surgery following each patient's hospital stay and up to 90 days from the initial operation.
Time frame: From date of surgery (POD=0) up to 90 postoperative days (POD=90)
Pathological response to chemo-radiation treatment
Pathological response to treatment will be classified as per protocol.
Time frame: From the date of the first chemotherapy to the date of surgery (around 4 months)
Plan to share: No
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Hamilton Health Sciences Corporation