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Anti-metabolites
Induction Chemotherapy for Esophageal Cancer
Phase 2
Waitlist Available
Led By Richard Dunne, MD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have ECOG performance status 0 or 1
Must have adequate organ function: ANC ≥ 1,500/mm3, Platelet count ≥ 100,000/mm3, Creatinine (Cr) ≤ 1.5 mg and/or creatinine clearance ≥ 60cc/min, Total bilirubin must be ≤ 1.5 x ULN unless the patient has a chronic grade 1 bilirubin elevation due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin, Alkaline phosphatase must be ≤ 2 x ULN, AST & ALT must be ≤ 3 x ULN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new chemotherapy regimen to see if it can decrease the rate of cancer recurrence.
Who is the study for?
This trial is for adults with locally advanced esophageal cancer that can potentially be removed by surgery. They must have good organ function, no prior treatments for esophageal cancer, not be pregnant or planning to become pregnant, and have no serious non-cancer illnesses or neuropathy.Check my eligibility
What is being tested?
The study tests if adding mFOLFOX6 chemotherapy before the usual chemoradiation treatment improves outcomes in patients with advanced esophageal cancer. It aims to reduce the chance of the cancer spreading elsewhere in the body.See study design
What are the potential side effects?
mFOLFOX6 may cause side effects like nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk and bleeding problems, nerve damage (neuropathy), and liver enzyme changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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My blood tests show my organs are functioning well.
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My cancer is confirmed to be in the esophagus, GE junction, or gastric cardia.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease-free survival rate
Secondary outcome measures
Overall disease-free survival
Overall survival
Pathologic examination
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Induction Chemotherapy /ChemoradiationExperimental Treatment2 Interventions
mFOLFOX6 for 3 cycles - Oxaliplatin 85 mg/m2, 5-fluorouracil 2400mg/m2/46 hours, 5-fluorouracil bolus 400mg/m2 and leucovorin 400 mg/m2, then chemoradiation for 5 cycles - Carboplatin AUC 2mg/mL/min, Paclitaxel 50 mg/m2 and radiation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Leucovorin
FDA approved
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
838 Previous Clinical Trials
518,527 Total Patients Enrolled
Richard Dunne, MD5.01 ReviewsPrincipal Investigator - University of Rochester Wilmot Cancer Center
University of Rochester
2 Previous Clinical Trials
68 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate to severe nerve damage.I've been cancer-free for over 5 years or had certain skin or in situ cancers treated effectively.I do not have any chronic diseases that would interfere with the study's treatment.My blood tests show my organs are functioning well.My disease can possibly be removed with surgery.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is confirmed to be in the esophagus, GE junction, or gastric cardia.I am not pregnant or nursing.I agree to use effective birth control.My cancer has spread to distant parts of my body.I am of childbearing age and might plan to have children.I am 18 years old or older.I have had chemotherapy, radiotherapy, or surgery for esophageal cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Induction Chemotherapy /Chemoradiation
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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.
Does the FDA condone chemoradiation as a treatment method?
"Chemoradiation is a Phase 2 trial, so there is some data supporting safety but none supporting efficacy."
Answered by AI
Chemoradiation is commonly used to treat which type of cancer?
"Chemoradiation is a common cancer treatment, but it can also be used to help patients with rectal carcinoma, advanced gastric cancer, and certain types of stem cell transplantation."
Answered by AI
What is the cap on recruitment for this clinical research?
"This clinical trial is no longer recruiting patients. The study was first posted on June 19th, 2017 and was edited for the last time on August 17th, 2022. However, there are 1691 other studies currently enrolling patients that suffer from cancer of the esophagus and 287 trials actively admitting patients for chemoradiation."
Answered by AI
Are there any current vacancies for this research project?
"According to the available information on clinicaltrials.gov, this study is not actively recruiting participants at this time. However, there are 1978 other trials that patients can participate in."
Answered by AI
Are there other precedents for this type of Chemoradiation treatment?
"As of right now, there are 1691 ongoing clinical trials related to chemoradiation therapy. 509 of these studies are in phase 3. Most research is being conducted in Guangzhou, Guangdong; however, there are 88133 locations around the world investigating chemoradiation as a treatment option."
Answered by AI
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