- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04452461
Pancreatic Adenocarcinoma Neoadjuvant Chemotherapy Before Surgery (PANCREAS)
mFOLFIRINOX or Gemcitabine / Nab-paclitaxel Followed by Pancreatectomy for Patients With Borderline Resectable Pancreatic Adenocarcinoma. A Pilot Feasibility Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Leyo Ruo, MD
- Phone Number: 76626 905-521-2100
- Email: ruol@mcmaster.ca
Study Contact Backup
- Name: Pablo E Serrano, MD
- Phone Number: 43872 905-521-2100
- Email: serrano@mcmaster.ca
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8V1C3
- Recruiting
- Juravinski Hospital
-
Contact:
- Leyo Ruo, MD
- Phone Number: 76626 905-521-2100
- Email: ruol@mcmaster.ca
-
Contact:
- Pablo E Serrano, MD
- Phone Number: 43872 905-521-2100
- Email: serrano@mcmaster.ca
-
Sub-Investigator:
- Pablo E Serrano, MD
-
Sub-Investigator:
- Brandon Meyers, MD
-
Sub-Investigator:
- Christian van der Pol, MD
-
Sub-Investigator:
- Tariq Aziz, MD
-
Sub-Investigator:
- Sameer Parpia, PhD
-
Sub-Investigator:
- Kimmen Quan, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Single Arm Intervention
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. |
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients eligible enrolled
Time Frame: 18 months
|
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:
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival
Time Frame: 24 months
|
Defined as percentage of patients alive at two years from enrolment.
|
24 months
|
Time to Progression
Time Frame: 24 months from the initiation of chemotherapy (the length of the study)
|
Defined as the duration of time from enrolment to time to radiological evidence of disease progression or recurrence or death, whichever comes first.
|
24 months from the initiation of chemotherapy (the length of the study)
|
Overall Complications from surgery
Time Frame: From date of surgery (POD=0) up to 90 postoperative days (POD=90)
|
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.
|
From date of surgery (POD=0) up to 90 postoperative days (POD=90)
|
Pathological response to chemo-radiation treatment
Time Frame: From the date of the first chemotherapy to the date of surgery (around 4 months)
|
Pathological response to treatment will be classified as per protocol.
|
From the date of the first chemotherapy to the date of surgery (around 4 months)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Leyo Ruo, MD, McMaster University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Protective Agents
- Antineoplastic Agents, Phytogenic
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Paclitaxel
- Oxaliplatin
- Leucovorin
- Gemcitabine
Other Study ID Numbers
- 5076
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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