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Chemotherapy
Neoadjuvant Chemotherapy for Pancreatic Cancer (PANCREAS Trial)
Phase 2
Recruiting
Led By Pablo E Serrano, MD
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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))
Age ≤ 79 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
PANCREAS Trial Summary
This trial is testing a new treatment for pancreatic cancer that may be more effective than current treatments.
Who is the study for?
This trial is for men and women aged 18-79 with borderline resectable pancreatic adenocarcinoma, who can consent to treatment and are fit for surgery. They must have good organ function and performance status (ECOG ≤1). Excluded are those with prior pancreas radiation, substance abuse issues, pregnancy, metastatic disease, serious heart conditions, chemotherapy contraindications, ongoing infections or pre-existing neuropathy.Check my eligibility
What is being tested?
The study tests the effectiveness of neoadjuvant chemotherapy using mFOLFIRINOX or gemcitabine/nab-paclitaxel in patients before they undergo pancreatectomy. It's a single-arm feasibility trial focused on individuals with borderline resectable pancreatic cancer at a single center.See study design
What are the potential side effects?
Potential side effects include reactions to chemotherapy such as nausea, fatigue, hair loss; blood cell count changes leading to increased infection risk; liver enzyme alterations; potential nerve damage manifesting as numbness or tingling.
PANCREAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood counts and liver/kidney functions are within normal ranges.
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I am 79 years old or younger.
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I am fully active or can carry out light work.
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I am 18 or older with a type of pancreatic cancer that might be removable by surgery.
PANCREAS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients eligible enrolled
Secondary outcome measures
Overall Complications from surgery
Pathological response to chemo-radiation treatment
Survival
+1 morePANCREAS Trial Design
1Treatment groups
Experimental Treatment
Group I: Single Arm InterventionExperimental Treatment2 Interventions
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.
Re-staging CT scan with Carbohydrate Antigen (CA) 19-9 serum test.
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
FDA approved
Find a Location
Who is running the clinical trial?
Hamilton Health Sciences CorporationLead Sponsor
368 Previous Clinical Trials
300,971 Total Patients Enrolled
Pablo E Serrano, MDPrincipal InvestigatorMcMaster University
Leyo Ruo, MDPrincipal InvestigatorMcMaster University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of serious heart conditions.My blood counts and liver/kidney functions are within normal ranges.I am 79 years old or younger.I am fully active or can carry out light work.I am currently fighting an infection in my body.I cannot receive chemotherapy due to health reasons.I have had radiation therapy targeting my pancreas.I am 18 or older with a type of pancreatic cancer that might be removable by surgery.You already have nerve damage before the study.My pancreatic cancer is advanced but has not spread far.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm Intervention
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who meets the eligibility requirements for participating in this research?
"Adenocarcinoma patients that meet the following requirements are encouraged to apply for this clinical trial: 1. Aged between 18-79 years old 2. ECOG performance status of 1 or below 3. Normal bone marrow and organ function, with a creatinine level < 150umol/L"
Answered by AI
Are there other examples of this proposed treatment being tested in a clinical setting?
"There are 1,530 ongoing studies investigating this medical intervention. Of those, 463 trials are in Phase 3. The large majority of these research projects are based in Guangzhou, Guangdong; however, there are 77669 locations running similar studies worldwide."
Answered by AI
What are the risks associated with this treatment method?
"While there is some data suggesting this treatment is safe, it only exists at a Phase 2 level. This means that, currently, there is no evidence to support its efficacy."
Answered by AI
Are volunteers being recruited for this research project at this time?
"This study, which can be found on clinicaltrials.gov, is actively looking for participants. The trial was first posted on March 1st 2021 and was last updated on August 5th 2022."
Answered by AI
Is this trial available to adults over the age of eighteen?
"This trial is only open to people between the ages of 18 and 79, as specified in the inclusion criteria."
Answered by AI
What are the main health concerns that this medication is meant to address?
"While malignant neoplasms is the primary condition that this treatment method is designed to target, it can also assist patients coping with non-small cell lung carcinoma, advanced gastric cancer, and anemia."
Answered by AI
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