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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

Serum creatinine < 1.5 x ULN or calculated creatinine clearance > 50 mL/min (using the Cockcroft-Gault formula)

ECOG performance status score of 0-1 (See Appendix).

Must not have

Known history of hepatitis B or hepatitis C.

Any contraindications to any of the study drugs of the chemotherapy regimens (FLOT or carboplatin/paclitaxel) selected by the investigator. Investigators should refer to the local package insert of the chemotherapy drugs.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

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.

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.

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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My kidney function, measured by creatinine levels, is within the normal range.

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I am fully active or can carry out light work.

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My liver tests are within normal limits.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of hepatitis B or C.

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I have no allergies or adverse reactions to the chemotherapy drugs used in this study.

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I have an active collagen vascular disease.

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I do not have unstable heart conditions or a history of certain heart rhythm problems.

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My cancer is in the esophagus or where the stomach meets the esophagus.

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My cancer is in the esophagus or where the stomach meets the esophagus and cannot be removed by surgery.

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I have had chemotherapy or radiation for esophageal cancer.

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I have mild or no nerve damage in my hands or feet.

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I have had radiotherapy in my chest or belly area that overlaps with where I need treatment now.

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I have a known DPD deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate the rate of pathologic complete response (pCR) to the study regimen.

Secondary study objectives

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

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,786 Previous Clinical Trials

2,787,568 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,002,960 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

~4 spots leftby Apr 2025

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