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Anti-metabolites
sFOLFOXIRI for Gastroesophageal Cancer
Phase 2
Recruiting
Led By Patrick Boland, MD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 - 2
Histologically and/or cytologically confirmed metastatic or unresectable adenocarcinoma of esophageal, gastroesophageal junction or gastric origin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three years
Awards & highlights
Study Summary
This trial is testing a new treatment regimen to see if it is effective in terms of objective response rate, progression free survival, and overall survival. They will also be looking at the safety and toxicity profile of the new treatment.
Who is the study for?
Adults with advanced gastroesophageal cancer that's HER2 negative and hasn't spread to the brain can join. They should be relatively fit (ECOG PS 0-2), have measurable disease, no recent major surgery or other cancers, and not be on high-dose steroids. No prior treatment for metastatic cancer is allowed except some mFOLFOX6 cycles.Check my eligibility
What is being tested?
The trial tests sFOLFOXIRI, a combination of chemotherapy drugs given in four-week cycles, to see how well it works against advanced gastroesophageal cancer by measuring tumor response rate, progression-free survival time, and overall survival time.See study design
What are the potential side effects?
Potential side effects include reactions to the chemo like nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems. There may also be liver issues due to elevated enzymes and possible nerve damage causing numbness or tingling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
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My cancer originates from the esophagus, gastroesophageal junction, or stomach and cannot be surgically removed.
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My tumor is not HER2 positive according to tests.
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I am 18 years old or older.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Event Rates
Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors ( RECIST) criteria version 1.1
Overall Survival (OS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: 4week alternating FOLFOX and a combination chemotherapy regime FOLFIRI (sFOLFOXIRI),Experimental Treatment1 Intervention
A cycle will constitute 28 days of treatment, which will consist of one chemotherapy combination, either FOLFOX or FOLFIRI as below:
Odd Cycles (e.g. 1, 3, 5, etc…) - mFOLFOX6 initiated on days 1 & 15: (Oxaliplatin 85 mg/m2 IV, leucovorin 400 mg/m2, 5FU 400 mg/m2 bolus, then 5FU 2400 mg/m2 over 46 hours)
Even Cycles (e.g. 2,4,6, etc…) - FOLFIRI initiated on days 1 & 15: (Irinotecan 180 mg/m2 IV, leucovorin 400 mg/m2, 5FU 400 mg/m2 bolus, then 5FU 2400 mg/m2 over 46 hours)
Nivolumab (optional, in-line with labelled approval) - 240 mg every 2 weeks
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,194 Total Patients Enrolled
Patrick Boland, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
1 Previous Clinical Trials
23 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use birth control or abstain from sex during the study.I have an autoimmune disease that hasn't needed strong medication in the last 2 years.I am not currently taking steroids equivalent to 10 mg/day of prednisone.I haven't had any other cancers in the last 3 years that could affect my treatment.I do not have any severe ongoing illnesses like heart failure or uncontrolled infections.I am allergic to one or more of the drugs used in this study.I have brain metastases that have not been treated.I have had interstitial lung disease or pneumonitis.I can take care of myself and am up and about more than half of my waking hours.I have had an organ or bone marrow transplant.My cancer originates from the esophagus, gastroesophageal junction, or stomach and cannot be surgically removed.I am willing and able to follow the study's schedule and procedures.I am going to receive nivolumab treatment.My tumor is not HER2 positive according to tests.I am 18 years old or older.I experience significant numbness or pain in my hands or feet.I have not had major surgery in the last 4 weeks.I've had up to two mFOLFOX6 treatments for my current illness.My blood and organ tests show they are working well.My kidney function, measured by creatinine levels or clearance, is within the required range.I haven't had systemic therapy for my current cancer in its advanced stage and it's been over 6 months since any peri-operative chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: 4week alternating FOLFOX and a combination chemotherapy regime FOLFIRI (sFOLFOXIRI),
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 participants will be included in the total of this medical trial?
"Affirmative. Clinicaltrials.gov depicts that the medical trial, originally posted on July 13th 2022, is actively recruiting volunteers. This intervention requires 38 participants to be recruited from 7 distinct sites."
Answered by AI
How many medical institutions are currently administering this experiment?
"The trial is occurring at 7 different locations, including RWJBarnabas Health - Community Medical Center in Toms River, RWJBarnabas Health - Monmouth Medical Centre in Long Branch, and RWJBarnabas Health - Robert Wood Johnson University Hospital in Hamilton. There are also 4 additional sites hosting the study."
Answered by AI
What measures are taken to guarantee the safety of patients undergoing this procedure?
"Even though there is limited clinical data suggesting efficacy, the safety of this treatment was rated as a 2 due to evidence provided in Phase 2 trials."
Answered by AI
Are there still opportunities for volunteers to join this research project?
"Affirmative. According to the data on clinicaltrials.gov, this clinical trial is currently recruiting candidates and was initially posted on July 13th 2022 with a subsequent update occurring in October 24th of that same year. 38 individuals are needed for participation at 7 sites across the nation."
Answered by AI
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