Pancreatic Adenocarcinoma Neoadjuvant Chemotherapy Before Surgery
ConditionPancreatic Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-79
SponsorHamilton Health Sciences Corporation
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
mFOLFIRINOX
DrugmFOLFIRINOX, 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.
Gemcitabine / Nab-paclitaxel
DrugBoth 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Single Arm InterventionOther 2 interventions
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
Survival
Defined as percentage of patients alive at two years from enrolment.
Time frame
24 months2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov