Pancreatic Adenocarcinoma Neoadjuvant Chemotherapy Before Surgery

NCT04452461 | Recruiting Phase 2 DMC

• 1 other identifier: 5076
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Adenocarcinoma

Outcome Measures

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

  18 months

Secondary Outcomes (4)

• Survival

  24 months

• Time to Progression

  24 months from the initiation of chemotherapy (the length of the study)

• Overall Complications from surgery

  From date of surgery (POD=0) up to 90 postoperative days (POD=90)

• Pathological response to chemo-radiation treatment

  From the date of the first chemotherapy to the date of surgery (around 4 months)

Study Arms (1)

Single Arm Intervention

OTHER

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

Interventions

mFOLFIRINOX DRUG

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

Single Arm Intervention

Gemcitabine / Nab-paclitaxel DRUG

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

Single Arm Intervention

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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

You may not qualify if:

• 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
• History of cardiac disease including congestive heart failure (New York Heart Association class 2), active coronary artery disease or uncontrolled hypertension
• Concurrent ongoing systemic infections
• Illegal substance abuse, or social conditions that may interfere with patient's participation in the trial
• Pre-existing neuropathy
• Pregnant patients

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Juravinski Hospital

Hamilton, Ontario, L8V1C3, Canada

RECRUITING

MeSH Terms

Interventions

Fluorouracil; Leucovorin; Oxaliplatin; Gemcitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Leyo Ruo, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leyo Ruo, MD

CONTACT

905-521-2100; ruol@mcmaster.ca

Pablo E Serrano, MD

CONTACT

905-521-2100; serrano@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 30, 2020
• Study Start: March 1, 2021
• Primary Completion: December 12, 2025
• Study Completion: May 1, 2026
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)