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Chemotherapy + Radiation for Esophageal Cancer
Study Summary
This trial tests a new combination of drugs to shrink tumors before surgery in people with cancer of the esophagus or gastroesophageal junction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a history of hepatitis B or C.I am a woman who can have children, have a negative pregnancy test, and will use birth control during and 3 months after the study.I have no allergies or adverse reactions to the chemotherapy drugs used in this study.My kidney function, measured by creatinine levels, is within the normal range.I do not have any serious health issues that could make this study unsafe for me.My kidney function, based on a formula considering my age, weight, and creatinine levels, is adequate.My cancer is in the esophagus or where it meets the stomach, hasn't spread far, and I haven't had treatment yet.I am fully active or can carry out light work.I am using or willing to use effective birth control or abstain from sex as required.I haven't had active cancer in the last 3 years, except for certain early stage cancers treated to cure.My liver tests are within normal limits.I am between 18 and 100 years old.My kidney function, based on my age, weight, and creatinine levels, is adequate.I have an active collagen vascular disease.My blood tests show normal white blood cells, hemoglobin, and platelets.I do not have unstable heart conditions or a history of certain heart rhythm problems.I am considered suitable for a treatment plan that includes radiation, chemotherapy, and surgery.My cancer is in the esophagus or where the stomach meets the esophagus.My cancer is in the esophagus or where the stomach meets the esophagus and cannot be removed by surgery.I have had chemotherapy or radiation for esophageal cancer.I have mild or no nerve damage in my hands or feet.I have had radiotherapy in my chest or belly area that overlaps with where I need treatment now.I have a known DPD deficiency.I have not had chemotherapy or radiation therapy before.
- Group 1: Sequential FLOT followed by chemoradiation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Who meets the prerequisites to be considered a viable candidate for this research?
"This medical trial is taking applications from individuals aged 18-100 who have been identified with adenocarcinoma. In order to qualify, they must be eligible for a trimodality therapy approach (radiation, chemotherapy and surgery), willing to comply with the procedures of the study, possess ECOG performance status score between 0-1 and demonstrate healthy bone marrow/liver function alongside creatinine levels under 1.5 x ULN or calculated creatinine clearance over 50 mL/min (using Cockcroft-Gault formula)."
Is the combination of Sequential FLOT and chemoradiation considered an acceptable course of action by the FDA?
"Our team at Power has rated Sequential FLOT combined with chemoradiation as a 2, due to the limited evidence of safety from Phase 2 trials and lack of efficacy data."
Are enrollment opportunities open for this research?
"According to clinicaltrials.gov, this research project is actively enrolling participants. It was first made available on the 11th of February 2020 and its last update occurred two years later on February 22nd 2022."
How many participants are participating in the experiment?
"Yes, according to clinicaltrials.gov, this research is presently soliciting participants; the initial posting date was February 11th 2020 and the latest update occurred on February 22nd 2022. The study calls for 40 candidates from 3 different locations to join in."
Does this research encompass participants aged 85 and over?
"This medical trial is open to participants aged 18-100, with separate trials for those under the age of 18 and over 65. Specifically, there are 7 clinical studies available for minors and 780 that focus on elderly patients."
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