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Anti-cancer chemotherapy

Chemotherapy + Radiation for Esophageal Cancer

Phase 2
Recruiting
Led By Jeffrey Olsen
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 2 weeks prior to study enrollment and must agree to follow instructions for method(s) of contraception for the duration of the study period and at least 3 months after the last dose of chemotherapy is administered. For the purpose of this study, a woman is considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
Serum creatinine < 1.5 x ULN or calculated creatinine clearance > 50 mL/min (using the Cockcroft-Gault formula)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

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.

Who is the study for?
This trial is for adults with newly diagnosed, resectable esophageal or gastroesophageal junction adenocarcinoma who haven't had chemotherapy or radiation. They must be fit enough for triple therapy (chemo, radiation, surgery), have proper kidney and liver function, and not be pregnant. Contraception is required during the study.Check my eligibility
What is being tested?
The trial tests a new treatment sequence starting with FLOT chemotherapy (docetaxel, oxaliplatin, leucovorin, 5-FU) followed by chemoradiation using carboplatin and paclitaxel before surgical removal of the cancer.See study design
What are the potential side effects?
Potential side effects include reactions to infusion drugs like fatigue and digestive issues; blood disorders; nerve damage risks; organ inflammation from chemo drugs; plus increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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My kidney function, measured by creatinine levels, is within the normal range.
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My kidney function, based on a formula considering my age, weight, and creatinine levels, is adequate.
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My cancer is in the esophagus or where it meets the stomach, hasn't spread far, and I haven't had treatment yet.
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I am fully active or can carry out light work.
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I am using or willing to use effective birth control or abstain from sex as required.
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My liver tests are within normal limits.
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I am between 18 and 100 years old.
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My kidney function, based on my age, weight, and creatinine levels, is adequate.
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My blood tests show normal white blood cells, hemoglobin, and platelets.
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I am considered suitable for a treatment plan that includes radiation, chemotherapy, and surgery.
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I have not had chemotherapy or radiation therapy before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Evaluate the rate of pathologic complete response (pCR) to the study regimen.
Secondary outcome measures
Measurement of change in the SUVmax on FDG-PET following induction FLOT, compared to initial diagnosis, and describe change in SUVmax among patients with and without a pCR to neoadjuvant therapy.
Measurement of ctDNA to generate initial descriptive data regarding ctDNA kinetics as a potential measure of treatment response
Patient reported quality of life
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sequential FLOT followed by chemoradiationExperimental Treatment1 Intervention
Sequential Chemotherapy with Docetaxel, Oxaliplatin, and 5-Fluorouracil/Leucovorin followed by chemoradiation with concurrent carboplatin and paclitaxel

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,795 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,729 Previous Clinical Trials
2,143,652 Total Patients Enrolled
Jeffrey OlsenPrincipal InvestigatorUniversity of Colorado, Denver

Media Library

Sequential FLOT (Anti-cancer chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04028167 — Phase 2
Esophageal Adenocarcinoma Research Study Groups: Sequential FLOT followed by chemoradiation
Esophageal Adenocarcinoma Clinical Trial 2023: Sequential FLOT Highlights & Side Effects. Trial Name: NCT04028167 — Phase 2
Sequential FLOT (Anti-cancer chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04028167 — Phase 2

Frequently Asked Questions

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

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)."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~0 spots leftby Apr 2024