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Anti-metabolites
Chemotherapy for Pancreatic Cancer (NeoPancOne Trial)
N/A
Waitlist Available
Led By Jennifer Knox, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
no involvement of the celiac artery, common hepatic artery or superior mesenteric artery (or if present a replaced right or common hepatic artery)
No evidence of metastases (i.e., metastatic work-up negative including a CT scan of the chest, abdomen (IV and oral contrast, 3 phase) and pelvis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-4 years
Awards & highlights
NeoPancOne Trial Summary
This trial will help researchers understand if a certain cancer treatment is effective and how biomarkers can be used to personalize cancer treatment.
Who is the study for?
This trial is for adults over 18 with confirmed pancreatic ductal adenocarcinoma (PDAC) that can be surgically removed. They must be fit for surgery and the mFFX chemotherapy, have no prior cancer treatments, and no evidence of metastases or other primary cancers in the last 3 years. Participants need proper liver and blood function, not be pregnant or breastfeeding, agree to use contraception if applicable, and provide consent.Check my eligibility
What is being tested?
The study tests how well patients with resectable pancreatic cancer respond to a chemotherapy regimen called modified Folforinox (mFFX) before and after surgery. It also examines whether GATA6 expression levels can predict treatment outcomes. This Canadian multicentre trial aims to personalize future treatment strategies.See study design
What are the potential side effects?
While specific side effects are not listed here, mFFX is an intensive chemotherapy regimen that may cause nausea, vomiting, diarrhea, low blood counts leading to increased infection risk or bleeding tendencies, fatigue, neuropathy (nerve damage), and possibly allergic reactions.
NeoPancOne Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has not spread to major arteries near my liver and stomach.
Select...
My scans show no signs of cancer spread.
Select...
My kidney function is normal based on my creatinine levels.
Select...
I am older than 18 years.
Select...
I agree to use two forms of birth control during and after the study.
Select...
I am fully active or can carry out light work.
Select...
I have not received any cancer treatment for my pancreatic cancer.
Select...
My pancreatic cancer is in the body or tail and can be surgically removed despite affecting the splenic blood vessels.
Select...
My liver is functioning well according to recent tests.
NeoPancOne Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess disease free survival (DFS) in resectable PDAC treated with peri-operative mFFX according to baseline GATA6 expression level
Secondary outcome measures
Assess pathological response rate to mFFX in the neoadjuvant setting
Determine GATA6 expression levels in EUS-FNB specimen compared to surgical specimen
Determine GATA6 in-situ hybridization (ISH)/immunohistochemistry (IHC) success rate
+10 moreSide effects data
From 2022 Phase 3 trial • 528 Patients • NCT0350442375%
Nausea
67%
Diarrhoea
59%
Fatigue
46%
Anaemia
43%
Decreased appetite
41%
Vomiting
41%
Neuropathy peripheral
37%
Hypokalaemia
37%
Constipation
35%
Abdominal pain
34%
Weight decreased
31%
Platelet count decreased
28%
Neutrophil count decreased
27%
Blood alkaline phosphatase increased
23%
Alanine aminotransferase increased
22%
Aspartate aminotransferase increased
21%
Hypoalbuminaemia
21%
Alopecia
21%
Peripheral sensory neuropathy
20%
Hyponatraemia
20%
Dysgeusia
20%
Stomatitis
19%
Neutropenia
19%
Dizziness
18%
Hypomagnesaemia
17%
Hypertension
17%
Oedema peripheral
17%
Back pain
16%
Hypophosphataemia
15%
White blood cell count decreased
15%
Pyrexia
15%
Dehydration
14%
Insomnia
14%
Lymphocyte count decreased
13%
Paraesthesia
13%
Asthenia
13%
Thrombocytopenia
13%
Hyperglycaemia
12%
Dyspepsia
12%
Hypocalcaemia
12%
Cough
12%
Temperature intolerance
11%
Dyspnoea
10%
Anxiety
10%
Mucosal inflammation
10%
Abdominal distension
9%
Activated partial thromboplastin time prolonged
9%
Gastrooesophageal reflux disease
9%
International normalised ratio increased
9%
Headache
9%
Hiccups
9%
Hypotension
8%
Epistaxis
8%
Pulmonary embolism
8%
Flatulence
8%
Abdominal pain upper
8%
Rash
7%
Dry mouth
7%
Depression
7%
Dry skin
7%
Arthralgia
7%
Rhinorrhoea
6%
Infusion related reaction
6%
Myalgia
6%
Non-cardiac chest pain
6%
Blood bilirubin increased
6%
Palmar-plantar erythrodysaesthesia
6%
Ascites
6%
Chills
6%
Pruritus
6%
Deep vein thrombosis
6%
Muscular weakness
5%
Fall
5%
Sinus tachycardia
5%
Embolism
5%
Cholinergic syndrome
4%
Hyperkalaemia
4%
Hyperhidrosis
4%
Pain in extremity
4%
Weight increased
4%
Sepsis
4%
Dysphagia
4%
Haematochezia
4%
Haemorrhoids
4%
Hypoglycaemia
4%
Syncope
4%
Vision blurred
4%
blood creatinine increased
4%
Hypertensive crisis
4%
Oropharyngeal pain
4%
Muscle spasms
3%
General physical health deterioration
3%
Hypernatraemia
3%
Contusion
3%
Hyperbilirubinaemia
3%
Rhinitis allergic
3%
Flushing
3%
Febrile neutropenia
3%
Leukocytosis
3%
Tachycardia
3%
Oral pain
3%
Upper respiratory tract infection
3%
Urinary tract infection
3%
Musculoskeletal pain
3%
Dysphonia
3%
Candida infection
3%
Rhinitis
3%
Diabetes mellitus
3%
Abdominal discomfort
3%
Colitis
3%
Pneumonia
3%
Flank pain
3%
Night sweats
2%
Hypoaesthesia
2%
Neck pain
2%
Urinary retention
2%
Urinary incontinence
2%
Hyperphosphataemia
2%
Dysarthria
2%
Device related infection
2%
Acute kidney injury
2%
Polyneuropathy
2%
Bacteraemia
2%
Hypermagnesaemia
2%
Dysaesthesia
2%
Oral candidiasis
2%
Oral herpes
2%
Electrocardiogram QT prolonged
2%
Upper gastrointestinal haemorrhage
2%
Septic shock
2%
Atrial fibrillation
2%
Bradycardia
2%
Sinus bradycardia
2%
Visual impairment
2%
Gastrointestinal haemorrhage
2%
Oesophagitis
2%
Catheter site pain
2%
Pain
2%
Peripheral swelling
2%
Bile duct obstruction
2%
Immune system disorders
2%
Influenza
2%
Oral fungal infection
2%
Neutrophil count increased
2%
Pancreatic enzymes decreased
2%
White blood cell count increased
2%
Disturbance in attention
2%
Pollakiuria
2%
Nasal congestion
2%
Pleural effusion
2%
Rash maculo-papular
2%
Skin hyperpigmentation
2%
Palpitations
2%
Gastritis
2%
Cholecystitis
2%
Cholestasis
2%
Gamma-glutamyltransferase increased
2%
Lymphocyte count increased
2%
Malnutrition
2%
Musculoskeletal chest pain
2%
Memory impairment
2%
Tremor
2%
Dysuria
2%
Erythema
2%
Rectal haemorrhage
2%
Abdominal pain lower
2%
Eructation
2%
Paraesthesia oral
2%
Proctalgia
2%
Localised oedema
2%
Micturition urgency
2%
Proteinuria
2%
Rash papular
2%
Catheter site infection
2%
Corona virus infection
2%
blood phosphorus decreased
2%
Bone pain
2%
Throat irritation
2%
Thrombophlebitis
1%
Feeling cold
1%
Biliary tract infection
1%
Urinary tract pain
1%
Gait disturbance
1%
Atelectasis
1%
Large intestine perforation
1%
Hypertriglyceridaemia
1%
Procedural pain
1%
Erythema multiforme
1%
blood magnesium decreased
1%
Ligament sprain
1%
Generalised oedema
1%
Tooth fracture
1%
Pancreatitis
1%
Malaise
1%
Ischaemic hepatitis
1%
Stress cardiomyopathy
1%
Duodenal obstruction
1%
Chromaturia
1%
Nail discolouration
1%
Hepatocellular injury
1%
Presyncope
1%
Scab
1%
Venous thrombosis
1%
Acute left ventricular failure
1%
Intestinal obstruction
1%
Small intestinal obstruction
1%
Diabetic ketoacidosis
1%
Mental status changes
1%
Leukopenia
1%
Lymphadenopathy
1%
Ventricular extrasystoles
1%
Dry eye
1%
Photophobia
1%
Enteritis
1%
Enterocolitis
1%
Gingival pain
1%
Haemorrhoidal haemorrhage
1%
Melaena
1%
Mouth ulceration
1%
Obstruction gastric
1%
Odynophagia
1%
Salivary hypersecretion
1%
Chest discomfort
1%
Oedema
1%
Biliary dilatation
1%
Gallbladder obstruction
1%
Abscess
1%
Herpes simplex
1%
Pharyngitis
1%
Rash pustular
1%
Sinusitis
1%
Blood bilirubin decreased
1%
Cardiac murmur
1%
Heart rate increased
1%
Protein total decreased
1%
Tumour pain
1%
Aphasia
1%
Ataxia
1%
Cerebrovascular accident
1%
Dizziness postural
1%
Device malfunction
1%
Device occlusion
1%
Agitation
1%
Confusional state
1%
Restlessness
1%
Haematuria
1%
Nocturia
1%
Dyspnoea exertional
1%
Laryngeal inflammation
1%
Pharyngeal inflammation
1%
Pneumonitis
1%
Productive cough
1%
Upper-airway cough syndrome
1%
Rash erythematous
1%
Skin discolouration
1%
Urticaria
1%
Pancytopenia
1%
Neurotoxicity
1%
Lacrimation increased
1%
Ocular hyperaemia
1%
Faeces pale
1%
Jaundice cholestatic
1%
Gastrointestinal pain
1%
Glossodynia
1%
Haematemesis
1%
Lip ulceration
1%
Lower gastrointestinal haemorrhage
1%
Toothache
1%
Device related thrombosis
1%
Early satiety
1%
Cholangitis
1%
Cholangitis acute
1%
Drug hypersensitivity
1%
Gastroenteritis
1%
Vulvovaginal mycotic infection
1%
Post procedural complication
1%
Thermal burn
1%
blood cholesterol increased
1%
Blood sodium decreased
1%
Hepatic enzyme increased
1%
Prothrombin time prolonged
1%
Transaminases increased
1%
Glucose tolerance impaired
1%
Hypercalcaemia
1%
Type 2 diabetes mellitus
1%
Fistula
1%
Encephalopathy
1%
Dermatitis acneiform
1%
Peroneal nerve palsy
1%
Hypoxia
1%
Nasal dryness
1%
Gout
1%
Blood creatinine increased
1%
Pancreatic failure
1%
Steatorrhoea
1%
Eye pain
1%
Abdominal hernia
1%
Abnormal faeces
1%
Aphthous ulcer
1%
Swelling
1%
Herpes zoster
1%
Limb injury
1%
Blood albumin decreased
1%
Speech disorder
1%
Renal failure
1%
Pelvic pain
1%
Decubitus ulcer
1%
Dyshidrotic eczema
1%
Ecchymosis
1%
Hypersensitivity
1%
Cellulitis
1%
Clostridium difficile colitis
1%
Clostridium difficile infection
1%
Joint swelling
1%
Muscle twitching
1%
Sneezing
1%
Orthostatic hypotension
1%
Pallor
1%
Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
CPI-613, mFolfirinox
Folfirinox
NeoPancOne Trial Design
1Treatment groups
Experimental Treatment
Group I: Neo-adjuvant mFFXExperimental Treatment1 Intervention
Neo-adjuvant mFFX up to 6 cycles, surgery, adjuvant chemotherapy for up tp 6 cycles, follow up
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,472 Previous Clinical Trials
484,920 Total Patients Enrolled
Pancreatic Cancer CanadaOTHER
1 Previous Clinical Trials
20 Total Patients Enrolled
Jennifer Knox, MDPrincipal InvestigatorPrincess Margaret Cancer Centre, University Health Network
7 Previous Clinical Trials
1,789 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor agrees I can handle mFFX treatment.My cancer has not spread to major arteries near my liver and stomach.I have been diagnosed with pancreatic cancer, confirmed by a specific biopsy.I have a history of heart rhythm issues or take medication that affects my heart rhythm.My pancreatic cancer cannot be removed by surgery, as confirmed by scans.My kidney function is normal based on my creatinine levels.I am healthy enough for surgery.I've had two unsuccessful attempts to confirm pancreatic cancer through EUS-FNB.My scans show no signs of cancer spread.I am older than 18 years.I agree to use two forms of birth control during and after the study.I am on coumadin and cannot switch to another blood thinner.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I haven't had another cancer, except for certain types, in the last 3 years.My pancreatic tumor can be surgically removed, as confirmed by a CT scan.My blood counts are within a healthy range.You have a known allergy to any of the drugs or ingredients used in the study.I lack the enzyme DPD entirely.I am not pregnant or breastfeeding.I have received treatment for pancreatic cancer before.I can sign and understand the consent form.I have had a bone marrow or stem cell transplant using my own cells.I am fully active or can carry out light work.I have not received any cancer treatment for my pancreatic cancer.My pancreatic cancer is in the body or tail and can be surgically removed despite affecting the splenic blood vessels.My pancreatic cancer was confirmed by a biopsy, and I did not consent to an EUS-FNB.You have a history of Gilbert's condition.My pancreatic cancer is not the common ductal type.My cancer has spread to other parts of my body.I agree to a biopsy for further analysis, unless my cancer was already confirmed with enough tissue for GATA6 analysis.My liver is functioning well according to recent tests.
Research Study Groups:
This trial has the following groups:- Group 1: Neo-adjuvant mFFX
Awards:
This trial has 1 awards, including:- 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.
How many individuals have been accepted to partake in this clinical trial?
"Affirmative. Clinicaltrials.gov displays that the recruitment for this clinical trial, which was posted on August 21st 2020, is still occurring. 84 individuals will be accepted from 8 separate sites for participation in this study."
Answered by AI
At what number of sites is this research endeavor being conducted?
"Currently, 8 clinical sites are inviting potential participants to join this trial. Toronto, London and Ottawa have medical centres taking part in the study as well as an additional 5 locations. To reduce travelling costs, it is wise for interested parties to select a clinic closest to their home address."
Answered by AI
Are there any current opportunities to join this scientific experiment?
"Affirmative. The clinical trial is currently accepting applicants, as evidenced by the information available on clinicaltrials.gov. This study was initially published on August 21st 2020 and has since been updated on June 24th 2021; with a total of 84 participants sought from 8 different medical centres."
Answered by AI
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