Study Summary
This trial will help researchers understand if a certain cancer treatment is effective and how biomarkers can be used to personalize cancer treatment.
Eligible Conditions
- Resectable Pancreatic Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 13 Secondary · Reporting Duration: 2-4 years
2-4 years
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
Determine the DFS according to R0 or R1 resection status
Determine the DFS according to baseline Ca19.9 levels
Determine the DFS according to modified Moffitt RNA classification
Determine the overall survival (OS) according modified Moffitt classification in the overall population and the GATA6 high/low populations
Determine the overall survival (OS) according to GATA6 expression level in the overall population and the GATA6 high/low populations
Determine the overall survival (OS) according to R0/R1 resection status in the overall population and the GATA6 high/low populations
Aminacrine
Determine the percentage of patients who progress on neoadjuvant mFFX
Evaluate the feasibility of EUS FNB as an effective modality for the detection of GATA6 expression at first diagnosis, including number of unsuccessful EUS-FNBs.
To assess disease free survival (DFS) in resectable PDAC treated with peri-operative mFFX according to baseline GATA6 expression level
To determine the overall response rate (ORR) to neoadjuvant mFFX
Trial Safety
Safety Progress
Side Effects for
Folfirinox
74%Diarrhoea
66%Nausea
54%Fatigue
43%Decreased appetite
41%Vomiting
40%Anaemia
37%Hypokalaemia
36%Abdominal pain
34%Neuropathy peripheral
33%Weight decreased
29%Constipation
29%Platelet count decreased
26%Peripheral sensory neuropathy
26%Neutrophil count decreased
21%Neutropenia
21%Hypomagnesaemia
20%Asthenia
20%Stomatitis
19%Blood alkaline phosphatase increased
18%Dysgeusia
18%Hypoalbuminaemia
17%Hyponatraemia
17%Alanine aminotransferase increased
17%Alopecia
17%Pyrexia
16%Thrombocytopenia
15%Dehydration
15%Oedema peripheral
15%Back pain
14%White blood cell count decreased
14%Aspartate aminotransferase increased
14%Paraesthesia
14%Dizziness
13%Hypophosphataemia
13%Insomnia
13%Dyspnoea
11%International normalised ratio increased
11%Headache
11%Dyspepsia
11%Hypotension
11%Cough
10%Lymphocyte count decreased
10%Hyperglycaemia
10%Hiccups
10%Hypocalcaemia
9%Gastrooesophageal reflux disease
9%Epistaxis
9%Mucosal inflammation
9%Temperature intolerance
9%Infusion related reaction
8%Hypertension
8%Febrile neutropenia
7%Blood bilirubin increased
7%Leukocytosis
7%Abdominal distension
6%Haemorrhoids
6%Chills
6%Activated partial thromboplastin time prolonged
6%blood creatinine increased
6%Arthralgia
6%Flatulence
5%Pruritus
5%Dry mouth
5%Abdominal pain upper
5%Ascites
5%Muscular weakness
5%Pneumonia
5%Urinary tract infection
5%Dysaesthesia
5%Cholangitis
5%Muscle spasms
5%Cholinergic syndrome
5%Anxiety
4%Immune system disorders
4%Depression
4%Musculoskeletal pain
4%Pain in jaw
4%Dysarthria
4%Dysphagia
4%Hyperkalaemia
4%Oropharyngeal pain
4%Pulmonary embolism
3%Hyperhidrosis
3%Palmar-plantar erythrodysaesthesia
3%Small intestinal obstruction
3%Dry eye
3%Malaise
3%Sepsis
3%Dry skin
3%Atrial fibrillation
3%Tremor
3%Erythema
3%Myalgia
3%Neck pain
3%Rash
3%Sinus tachycardia
3%Non-cardiac chest pain
3%Pain
3%Oral candidiasis
3%Acute kidney injury
3%Pain in extremity
3%Productive cough
3%Deep vein thrombosis
2%Gastrointestinal haemorrhage
2%Portal vein thrombosis
2%Syncope
2%Salivary hypersecretion
2%Upper respiratory tract infection
2%Vulvovaginal mycotic infection
2%Diabetes mellitus
2%Oral pain
2%Peripheral motor neuropathy
2%Night sweats
2%Rhinorrhoea
2%Hypernatraemia
2%Bone pain
2%Neurotoxicity
2%Haematuria
2%Abdominal pain lower
2%Colitis
2%Bile duct obstruction
2%Nasopharyngitis
2%Protein total decreased
2%Malnutrition
2%Musculoskeletal chest pain
2%Hypermagnesaemia
2%Rash maculo-papular
2%Vision blurred
2%Abdominal rigidity
2%Proctalgia
2%Weight increased
2%Toothache
2%Pancreatic enzymes decreased
2%Hypoglycaemia
2%Flank pain
2%Upper-airway cough syndrome
2%Dermatitis acneiform
2%Pancytopenia
2%Tachycardia
2%Pancreatic failure
2%General physical health deterioration
2%Oedema
2%Hepatocellular injury
2%Lung infection
2%Contusion
2%Fall
2%Hypoaesthesia
2%Sleep disorder
2%Pollakiuria
2%Abdominal discomfort
2%Anal fissure
2%Early satiety
2%Urinary retention
2%Dysphonia
2%Nasal congestion
1%Pancreatitis
1%Rectal haemorrhage
1%Tooth infection
1%Transaminases increased
1%Somnolence
1%Chromaturia
1%Skin hyperpigmentation
1%Eructation
1%Oesophagitis
1%Oral dysaesthesia
1%Erysipelas
1%Hyperphosphataemia
1%Dysuria
1%Duodenal obstruction
1%Influenza like illness
1%Peritonitis bacterial
1%Tinea pedis
1%blood glucose increased
1%Iron deficiency
1%Vitamin K deficiency
1%Polyneuropathy
1%Skin ulcer
1%Pain of skin
1%Thrombophlebitis superficial
1%Periodontal disease
1%Gingival bleeding
1%Haemorrhoidal haemorrhage
1%Hypoaesthesia oral
1%Device related thrombosis
1%Device occlusion
1%Blood sodium decreased
1%Decubitus ulcer
1%Lymphopenia
1%Anal incontinence
1%Haematemesis
1%Haematochezia
1%Lip ulceration
1%Small intestinal haemorrhage
1%Localised oedema
1%Rhinitis
1%blood phosphorus increased
1%Joint stiffness
1%Spinal pain
1%Neuralgia
1%Presyncope
1%Urticaria
1%Gastroenteritis
1%Rhinitis allergic
1%Retching
1%Catheter site pain
1%Cholecystitis
1%Herpes zoster
1%Hordeolum
1%Tonsillitis
1%Thrombosis
1%Ileus
1%Cholestasis
1%Cell death
1%Musculoskeletal stiffness
1%Memory impairment
1%Muscle spasticity
1%Restless legs syndrome
1%Stent malfunction
1%Confusional state
1%Cystitis noninfective
1%Dyspnoea exertional
1%Skin fissures
1%Septic shock
1%Tongue fungal infection
1%Pneumonitis
1%Palpitations
1%Sinus bradycardia
1%Gastrointestinal motility disorder
1%Gastrointestinal pain
1%Obstruction gastric
1%Steatorrhoea
1%Chest discomfort
1%Feeling cold
1%Feeling hot
1%Generalised oedema
1%Peripheral swelling
1%Hyperbilirubinaemia
1%Drug hypersensitivity
1%Hypersensitivity
1%Bacteraemia
1%Candida infection
1%Corona virus infection
1%Oesophageal candidiasis
1%Oral fungal infection
1%Subcutaneous abscess
1%blood potassium decreased
1%Gamma-glutamyltransferase increased
1%Hepatic enzyme increased
1%Neutrophil count increased
1%Failure to thrive
1%Hypercalcaemia
1%Joint swelling
1%Limb discomfort
1%Aphasia
1%Cerebrovascular accident
1%Panic attack
1%Benign prostatic hyperplasia
1%Hypoxia
1%Wheezing
1%Orthostatic hypotension
1%Atrial flutter
1%Visual impairment
1%Vitreous floaters
1%Anal haemorrhage
1%Gastric varices
1%Seasonal allergy
1%Abdominal infection
1%Urinary incontinence
1%Pleural effusion
Trial Design
1 Treatment Group
Neo-adjuvant mFFX
1 of 1
Experimental Treatment
84 Total Participants · 1 Treatment Group
Primary Treatment: Modified Folforinox (mFFX) · No Placebo Group · N/A
Neo-adjuvant mFFX
Drug
Experimental Group · 1 Intervention: Modified Folforinox (mFFX) · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2-4 years
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,386 Previous Clinical Trials
471,885 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
1,791 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer