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Anti-metabolites

Folfirinox + SBRT for Pancreatic Cancer (BCC-RAD-13 Trial)

Phase 2
Waitlist Available
Led By Neal E Dunlap, MD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Imaging as follows: CT scan of the chest, abdomen and pelvis with IV and oral contrast within 8 weeks of registration, Whole body PET scan within 8 weeks of registration, Evaluation by a surgical oncologist to determine non-resectability, Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
CBC/differential obtained within 14 days prior to registration with adequate bone marrow function as follows: ANC > 1,500 cell/mm3, Platelets > 100,000 cells/mm3, Hemoglobin > 8.0 g/dl (transfusion to obtain this value is permissible), Additional labs within 14 days prior to registration: CA 19-9, Creatinine <2mg/dl, Bilirubin <2mg/dl, AST and ALT < 2.5 x ULN, Patients must provide study specific informed consent prior to study entry.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 3 months, 6 months, 9 months and 12 months post-treatment
Awards & highlights

BCC-RAD-13 Trial Summary

This trial is testing a new combination of two cancer treatments to see if it is safe and effective for pancreatic cancer.

Who is the study for?
This trial is for adults over 18 with advanced pancreatic cancer that hasn't spread elsewhere. They must be in good physical condition, have not had previous cancer treatments within the last 3 years, and cannot be pregnant or breastfeeding. Participants need a recent CT scan, PET scan, and blood tests showing adequate organ function.Check my eligibility
What is being tested?
The study is testing how well Folfirinox (a combination of chemotherapy drugs) works alongside Stereotactic Body Radiation Therapy (SBRT), which is a targeted form of radiation therapy aimed at treating pancreatic cancer.See study design
What are the potential side effects?
Folfirinox can cause side effects like nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems. SBRT may result in fatigue, skin reactions at the treatment site, and potential damage to nearby organs.

BCC-RAD-13 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Your recent blood tests show that you have enough healthy blood cells and your organs are functioning properly. You need to agree to take part in the study.
Select...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
Select...
I have been diagnosed with pancreatic cancer.

BCC-RAD-13 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at 3 months, 6 months, 9 months and 12 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 3 months, 6 months, 9 months and 12 months post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Grade 3 or Higher Adverse Event(s) as a Measure of Safety and Tolerability
Secondary outcome measures
Overall Response Rate for Participants as Assessed by Contrast-enhanced CT Scan of the Abdomen at 12 Months.
Other outcome measures
Quality of Life Assessment at 12 Months Post-treatment

Side effects data

From 2022 Phase 3 trial • 528 Patients • NCT03504423
75%
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%
Pain in extremity
4%
Hyperhidrosis
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%
Hyperphosphataemia
2%
Neck pain
2%
Urinary retention
2%
Urinary incontinence
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%
Large intestine perforation
1%
Biliary tract infection
1%
Generalised oedema
1%
blood magnesium decreased
1%
Ligament sprain
1%
Gait disturbance
1%
Procedural pain
1%
Tooth fracture
1%
Hypertriglyceridaemia
1%
Pancreatitis
1%
Malaise
1%
Ischaemic hepatitis
1%
Atelectasis
1%
Urinary tract pain
1%
Erythema multiforme
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

BCC-RAD-13 Trial Design

1Treatment groups
Experimental Treatment
Group I: Folririnox with SBRTExperimental Treatment2 Interventions
Folfirinox Oxaliplatin 85 mg/m² for over 2 hours, Leucovorin 400n mg/m² for over 2 hours, Irinotecan 180 mg/m² for over 90 minutes, along with Leucovorin infusion Fluorouracil 400 mg/m² as a fast infusion over 15 minutes Fluorouracil 2400 mg/m² as a slow infusion over 46 hours SBRT 5 treatments of stereotactic body radiation therapy (SBRT) over the course of two weeks with a minimum of 36 hours in between each treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Oxaliplatin
FDA approved

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
336 Previous Clinical Trials
75,935 Total Patients Enrolled
James Graham Brown Cancer CenterOTHER
43 Previous Clinical Trials
9,213 Total Patients Enrolled
Neal E Dunlap, MDPrincipal InvestigatorJames Graham Brown Cancer Center
2 Previous Clinical Trials
94 Total Patients Enrolled

Media Library

Folfirinox (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02128100 — Phase 2
Pancreatic Cancer Research Study Groups: Folririnox with SBRT
Pancreatic Cancer Clinical Trial 2023: Folfirinox Highlights & Side Effects. Trial Name: NCT02128100 — Phase 2
Folfirinox (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02128100 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are engaged in this clinical research?

"Affirmative. Clinicaltrials.gov registers that this clinical trial is currently recruiting new patients, which was first published on the 1st of May 2014 and most recently edited on October 24th 2019. The study requires 28 participants from a single medical centre to participate in it."

Answered by AI

To what maladies does Folfirinox typically provide relief?

"Folfirinox has been commonly used to manage rectal carcinoma; however, it can also benefit patients dealing with colorectal carcinoma, ovarian cancer and sarcoma."

Answered by AI

Is there presently an opportunity to join this clinical trial?

"Affirmative. This trial is currently gathering participants, as per the information found on clinicaltrials.gov; it was initially listed on May 1st 2014 and its most recent alterations were made October 24th 2019. To complete this medical experiment, 28 individuals must be enrolled at one location."

Answered by AI

Has Folfirinox been sanctioned by the FDA?

"The safety of Folfirinox stands at a score 2 on the 1 to 3 scale. This is because, while there is evidence that it may be safe for use, no data has been collected yet which shows its efficacy."

Answered by AI

Have previous investigations utilized Folfirinox for research purposes?

"Currently, there are 643 investigations involving Folfirinox underway with 201 of them being in Phase 3. The trials for this drug have been set up across 27,590 locations, including Guangzhou and Guangdong."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effects of Folfirinox and Stereotactic Body Radiation Therapy for Advanced Pancreatic Cancer
Neal Edward Dunlap 2014. "Effects of Folfirinox and Stereotactic Body Radiation Therapy for Advanced Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02128100.
~0 spots leftby Apr 2025
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