Your session is about to expire
← Back to Search
Anti-metabolites
mFOLFIRINOX for Stomach Cancer
Phase 4
Recruiting
Led By Daniel Catenacci
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed locally advanced gastric or esophagogastric adenocarcinoma
Eligible for surgery with curative intent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well a combination of modified fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin works in treating patients with gastroesophageal or stomach cancer.
Who is the study for?
This trial is for adults with advanced gastroesophageal or stomach cancer without distant spread. They must be fit for surgery, have certain blood counts and organ functions within set limits, not be pregnant, agree to use birth control, and can't have other cancers or serious illnesses that could interfere with the study.Check my eligibility
What is being tested?
The trial tests a personalized dose of Irinotecan in the mFOLFIRINOX regimen (a combination of chemotherapy drugs) based on genetic analysis. The goal is to see if tailoring the dose improves tolerance and effectiveness against locally advanced gastroesophageal or stomach cancer.See study design
What are the potential side effects?
Chemotherapy may cause side effects like nausea, vomiting, diarrhea, fatigue, risk of infection due to low blood cell counts, nerve damage leading to numbness or tingling sensations (neuropathy), liver enzyme changes indicating liver stress or damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of stomach or esophagus cancer confirmed by tissue analysis.
Select...
I am a candidate for surgery aimed at curing my condition.
Select...
My disease is advanced but has not spread far, as shown by a special ultrasound.
Select...
I have had a laparoscopy and diagnostic fluid tests for cancer cells.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My liver tests are within required ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
R0 (analysis will be performed evaluating the R0 rate)
Secondary outcome measures
Incidence of toxicity based on NCI-CTCAE v 4.0
OS (estimated using the Kaplan-Meier procedure and compared in the subgroups of patients with and without pCR (grade 1a) using the log-rank test)
Pattern of recurrence
+3 moreOther outcome measures
Change in SUVmax for PET/CT studies
Change in SUVmax for the primary esophageal tumor
Circulating tumor cell (CTC) numbers derived from portal and peripheral blood samples
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (mFOLFIRINOX, surgery)Experimental Treatment5 Interventions
PREOPERATIVE THERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV over 46 hours continuously on day 1. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Patients undergo conventional surgery.
POST-OPERATIVE THERAPY: Beginning 5-10 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV over 46 hours continuously on day 1. Courses repeat every 2 weeks for 4 more courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
2014
Completed Phase 3
~11540
Conventional Surgery
2006
Completed Phase 3
~1080
Oxaliplatin
2011
Completed Phase 4
~2560
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Leucovorin Calcium
2011
Completed Phase 3
~12310
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,741 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,869 Total Patients Enrolled
Daniel CatenacciPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is a type of stomach or esophagus cancer confirmed by tissue analysis.I am a candidate for surgery aimed at curing my condition.I am willing to change my medication if it affects my treatment.I have moderate to severe nerve damage.My disease is advanced but has not spread far, as shown by a special ultrasound.I have had a laparoscopy and diagnostic fluid tests for cancer cells.I am fully active and can carry on all pre-disease activities without restriction.My liver tests are within required ranges.My genetic test shows I have a UGT1A1 variant that is not *1 or *28.I have experienced mild to severe diarrhea.I am currently experiencing uncontrolled bleeding.I have had cancer before, but it fits the exceptions.I have not had major surgery in the last 4 weeks.I have inflammatory bowel disease that is not under control or currently being treated.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (mFOLFIRINOX, surgery)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
In what medical context is Fluorouracil typically employed?
"Fluorouracil is a reliable treatment for rectal carcinoma, colorectal carcinoma and ovarian cancer."
Answered by AI
Does this research endeavor have any open positions for participants?
"According to clinicaltrials.gov, this research is actively seeking participants since it was first posted on December 11th 2014 and recently updated on June 3rd 2022."
Answered by AI
What is the sample size of the ongoing experiment?
"Affirmative. According to clinicaltrials.gov, this ongoing trial was initially published on December 11th 2014 and last updated on June 3rd 2022. It is seeking 36 volunteers distributed over 3 locations."
Answered by AI
Are there any other previous investigations that have utilized Fluorouracil?
"As of now, 644 clinical investigations into Fluorouracil are underway. Of these trials, 201 have already progressed to Phase 3 while the rest remain in earlier stages. The majority of studies related to this drug occur within Guangzhou, Guangdong but there are over 27 thousand total locations where research involving Fluorouracil is conducted."
Answered by AI
Has the Federal Drug Administration authorized Fluorouracil?
"Fluorouracil's safety was rated a 3, as this is already an approved and widely used treatment."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger