← Back to Search

Anti-metabolites

Perioperative Chemotherapy for Pancreatic Cancer

Phase 3
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Less than 180 degree interface between tumor and vessel wall of the portal vein or superior mesenteric vein, and patent portal vein/splenic vein confluence
TNM Stage: Tx-4, N0-1, M0 (M0 disease does not include spread to distant lymph nodes and organs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time between randomization and death from any cause, assessed up to 6 years.
Awards & highlights

Study Summary

This trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery.

Who is the study for?
This trial is for adults with removable pancreatic cancer who have not had prior treatments. They must have normal bilirubin and creatinine levels or adequate kidney function, no severe liver conditions like Gilbert's Syndrome, and be fit for surgery. Pregnant or nursing women can't join, nor those on certain drugs affecting the liver enzyme CYP3A4. Participants need to be in good physical condition (ECOG 0-1) with minimal nerve damage from neuropathy.Check my eligibility
What is being tested?
The study compares two approaches using chemotherapy drugs fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin: one where patients receive chemo before and after surgery (perioperative), versus only after surgery (adjuvant). The goal is to see which method is more effective at treating pancreatic cancer that can be surgically removed.See study design
What are the potential side effects?
Possible side effects of the chemotherapy may include nausea, vomiting, diarrhea, fatigue, hair loss, decreased blood cell counts leading to increased infection risk or bleeding problems. Nerve damage causing numbness or tingling in hands and feet might also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My tumor partially touches the blood vessels near my liver or intestine but hasn't blocked them.
Select...
My cancer has not spread to distant parts of my body.
Select...
I have not had any treatment for pancreatic cancer.
Select...
My kidney function, measured by creatinine levels or clearance, is within the required range.
Select...
I do not have Gilbert's Syndrome or a specific genetic condition.
Select...
I have no health issues that prevent surgery to remove pancreatic cancer.
Select...
My cancer is confirmed as pancreatic adenocarcinoma or adenosquamous carcinoma.
Select...
My tumor can be surgically removed according to my scans.
Select...
I am not pregnant or breastfeeding.
Select...
My disease is confirmed to be removable by surgery according to a specialized imaging review.
Select...
I am not taking strong CYP3A4 inhibitors, or I can stop them before joining.
Select...
I am not taking any strong CYP3A4 inducer medications.
Select...
I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time between randomization and death from any cause, assessed up to 6 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and time between randomization and death from any cause, assessed up to 6 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival
Disease-free survival (DFS)
Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received
+12 more

Side effects data

From 2016 Phase 2 trial • 60 Patients • NCT00096226
93%
Fatigue
81%
Dyspnea
72%
Cough
67%
Hemoglobin
65%
Leukopenia NOS
61%
Nausea
60%
Anorexia
60%
Hyperglycemia NOS
58%
Dysphagia
56%
Esophagitis NOS
53%
Dermatitis radiation NOS
49%
Peripheral sensory neuropathy
46%
Weight decreased
44%
Constipation
44%
Alopecia
39%
Neutrophil count
35%
Pneumonitis NOS
33%
Chest pain
32%
Skin hyperpigmentation
30%
Platelet count decreased
30%
Chest wall pain
28%
Hypoalbuminemia
26%
Hyponatremia
25%
Pleural effusion
25%
Diarrhea NOS
25%
Lymphopenia
23%
Dyspepsia
23%
Vomiting NOS
21%
Aspartate aminotransferase increased
21%
Arthralgia
21%
Insomnia
19%
Sinus tachycardia
19%
Alanine aminotransferase increased
19%
Dehydration
19%
Hypocalcemia
19%
Myalgia
19%
Pain - Other
18%
Atelectasis
18%
Pneumothorax NOS
18%
Pericardial effusion
18%
Supraventricular arrhythmia NOS
18%
Hypokalemia
18%
Pyrexia
18%
Esophageal pain
16%
Blood alkaline phosphatase increased
16%
Hyperkalemia
16%
Dysgeusia
14%
Pharyngolaryngeal pain
14%
Hypomagnesemia
14%
Back pain
14%
Dizziness
14%
Headache
14%
Pruritus
12%
Pulmonary fibrosis
12%
Blood/bone marrow - Other
12%
Dry skin
12%
Sweating increased
12%
Hypersensitivity NOS
11%
Hypoxia
11%
Laryngitis NOS
11%
Radiation recall syndrome
11%
Metabolic/laboratory - Other
11%
Pain in extremity
11%
Dermatitis exfoliative NOS
11%
Depression
11%
Hypotension NOS
9%
Pulmonary/upper respiratory - Other
9%
Blood bilirubin increased
9%
Dry mouth
9%
Stomatitis
9%
Blood creatinine increased
9%
Anxiety
9%
Dermatology/skin - Other
9%
Thrombosis
7%
Bronchospasm
7%
Hot flushes NOS
7%
Edema: limb
7%
Hypermagnesemia
7%
Bone pain
7%
Pollakiuria
7%
Rigors
5%
Rhinitis allergic NOS
5%
Epistaxis
5%
Prolonged chest tube drainage or air leak after pulmonary resection
5%
Vision blurred
5%
Gastritis NOS
5%
Mucositis/stomatitis (functional/symptomatic): Esophagus
5%
Blood bicarbonate decreased
5%
Hypercalcemia
5%
Hypophosphatemia
5%
Ataxia
5%
Muscle weakness NOS
5%
Peripheral motor neuropathy
5%
Confusional state
2%
Colonic obstruction
2%
Arrhythmia NOS
2%
Ocular/visual - Other
2%
Ileus paralytic
2%
Abdominal distention
2%
Myocardial ischemia
2%
Serum sickness
2%
Anal infection NOS
2%
Gingival infection
2%
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
2%
Erythema multiforme
2%
Syncope
2%
Urinary retention
2%
Acute respiratory distress syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemoradiation, Surgery, Chemotherapy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (perioperative chemotherapy, surgery)Experimental Treatment6 Interventions
Patients receive oxaliplatin intravenously (IV) over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Within 2-8 weeks of completing neoadjuvant chemotherapy, patients undergo surgical resection. Patients then receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (surgery, adjuvant chemotherapy)Active Control6 Interventions
Patients undergo surgical resection. Beginning 3-12 weeks after surgery, patients then receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 12 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
FDA approved
Oxaliplatin
FDA approved
Fluorouracil
FDA approved
Leucovorin
FDA approved
Resection
2021
Completed Phase 2
~410

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,286 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,553 Total Patients Enrolled
Cristina R. Ferrone, MDStudy ChairMassachusetts General Hospital

Media Library

Fluorouracil (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04340141 — Phase 3
Pancreatic Cancer Research Study Groups: Arm I (perioperative chemotherapy, surgery), Arm II (surgery, adjuvant chemotherapy)
Pancreatic Cancer Clinical Trial 2023: Fluorouracil Highlights & Side Effects. Trial Name: NCT04340141 — Phase 3
Fluorouracil (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04340141 — Phase 3

Frequently Asked Questions

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

What do other researchers say about the benefits of Resection?

"At the moment, there are 677 ongoing clinical trials studying Resection. Out of these, 207 studies have progressed to Phase 3. The majority of these trials originate in Guangzhou, Guangdong; however, there are a total of 28743 locations running clinical trials for Resection."

Answered by AI

How many total people are enrolled in this research project?

"In order to properly run this trial, 352 individuals who match the pre-specified inclusion criteria are needed. These people can be recruited from various locations, such as Memorial Sloan Kettering Nassau in Uniondale, New york and Sanford Roger Maris Cancer Center in Fargo, North dakota."

Answered by AI

How many different medical clinics are conducting this study?

"This clinical trial has 34 recruiting sites, including Memorial Sloan Kettering Nassau in Uniondale, Sanford Roger Maris Cancer Center in Fargo, and Wayne State University/Karmanos Cancer Institute in Detroit."

Answered by AI

What maladies does Resection usually alleviate?

"Rectal carcinoma can usually be treated effectively through surgery (resection). This same surgical procedure can also help treat other conditions including colorectal carcinoma, ovarian cancer, and sarcoma."

Answered by AI

Are there any available positions for volunteers in this research project?

"Yes, the trial is ongoing and has 352 patients as its goal. The listing on clinicaltrials.gov says that the study was first posted on 7/1/2020, with the most recent update being 8/1/2022. There are 34 locations recruiting patients for this study."

Answered by AI

What are some of the risks associated with Resection?

"Resection is considered safe by our team, who gave it a score of 3. This is due to Phase 3 trials, where there is some data affirming the efficacy of Resection as well as multiple rounds of data supporting its safety."

Answered by AI

Who else is applying?

What site did they apply to?
Thomas Jefferson University Hospital
BCCA-Vancouver Cancer Centre
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer
2020. "Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04340141.
All > Paid Studies Wyoming
~107 spots leftby Jan 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top