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Sequential FLOT followed by chemoradiation for Esophageal Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Esophageal Adenocarcinoma+1 MoreSequential FLOT followed by chemoradiation - Drug
Eligibility
18 - 100
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Esophageal Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Dose Escalation (Phase 1)
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Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 5 years

5 years
Evaluate the rate of pathologic complete response (pCR) to the study regimen.
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
To describe toxicity of the study regimen as a component of neoadjuvant therapy for the study population.
To determine estimates of the 1-year overall survival and disease-free survival among patients treated with the study regimen.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
Atezolizumab
1
Dose Escalation (Phase 1)
1
Pembrolizumab

Trial Design

1 Treatment Group

Sequential FLOT followed by chemoradiation
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Sequential FLOT followed by chemoradiation · No Placebo Group · Phase 2

Sequential FLOT followed by chemoradiation
Drug
Experimental Group · 1 Intervention: Sequential FLOT followed by chemoradiation · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,076 Previous Clinical Trials
41,139,508 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,593 Previous Clinical Trials
1,927,526 Total Patients Enrolled

Eligibility Criteria

Age 18 - 100 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects must be deemed a candidate for trimodality therapy (radiation, chemotherapy and surgery) based upon multidisciplinary evaluation with plan for preoperative chemoradiation followed by surgical resection.
You are willing to comply with all study procedures and be available for the duration of the study.
You have a performance status of 0-1.
You have a serum creatinine level that is greater than 1.5 times the upper limit of normal.
References

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