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Chemotherapy with Radiation for Esophageal Adenocarcinoma

This study is looking at a new way to treat esophageal adenocarcinoma, a type of cancer in the esophagus (food pipe). It tests if adding more chemotherapy (FOLFOX or FLOT) after standard chemotherapy and radiation can better control the cancer and reduce the need for surgery. You might be able to join if you have newly diagnosed Stage II-IVA esophageal adenocarcinoma (excluding T4b) and are at least 18 years old. The main goal is to see how many participants achieve a complete response to treatment, meaning no signs of cancer, measured around 36 weeks. The study plans to enroll 60 participants. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 60 participants. It is testing a specific treatment approach.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at approximately 36 weeks, which gives an idea of the follow-up duration for that specific outcome.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07603375

Upfront Chemotherapy With Radiation Therapy (CRT) Followed by Chemotherapy in Localized Esophageal Adenocarcinoma

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Duke University
~60 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Clinical complete response (cCR)
Measured over approximately 36 weeks

Conditions

Esophageal Adenocarcinoma

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Esophageal Adenocarcinoma

NCT07603375

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Duke University Medical Center

    Durham, North Carolinastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Manisha Palta, MD · PRINCIPAL_INVESTIGATOR · Duke Health

Who to contact

Clinical Trials Office
[email protected]
(919) 668-3726
Email the study team

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Eligibility criteria

Inclusion

Subject must be able to provide study specific informed consent prior to study entry
Must be newly diagnosed, histologically proven diagnosis of adenocarcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II);
Stage II-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th edition;
Complete history and physical examination within 21 days of signing consent;
Staging whole-body FDG-PET/CT (fluorodeoxyglucose-positron emission tomography/computed tomography) scan with or without contrast (preferred) or chest/abdominal (CT with contrast) confirming there is no evidence of metastatic disease must be obtained within 45 days of study enrollment
ECOG (Eastern Cooperative Oncology Group) performance status of 0-2
Subjects must be appropriate candidates for planned chemoradiation (concurrent carboplatin/paclitaxel) and chemotherapy (FLOT, m-FOLFOX-6) as determined by the treating radiation oncologist, medical oncologist, and surgical oncologist.
Adequate hematologic, renal, and hepatic function within 14 days of initiation of therapy

Exclusion

Cervical esophageal cancers arising 15-18 cm from the incisors.
Esophageal squamous cell carcinoma.
Patients with T4b disease according to the AJCC 8th Edition.
Definitive clinical or radiologic evidence of metastatic disease.
Has had prior systemic therapy or radiation therapy for the current diagnosis.
Prior thoracic radiotherapy for any reason that would result in overlap of radiation therapy fields; all patients with prior radiotherapy must be reviewed by the PI to determine if patient is eligible.
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
Severe, active co-morbidity defined as follows:
Active uncontrolled infection requiring IV antibiotics;
Pregnant and/or nursing subjects;
HIV positive with CD4 count \< 200 cells/microliter. Note that subjects who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
Has a history or current evidence of physical or physiological contraindication to participation in this study, at the discretion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

What this trial measures

  • Number of participants with Clinical complete response (cCR)approximately 36 weeks

    cCR defined as absence of malignancy on endoscopic biopsies obtained at the time of reassessment following neoadjuvant therapy