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RecruitingNCT07603375TNT EsophagusUpdated Sep 29, 2026

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

A Phase 2 interventional study of FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) in Esophageal Adenocarcinoma, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Duke University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this trial is to learn if adding consolidative chemotherapy to routine chemoradiation can better control both local recurrence and metastasis and reduce the need for surgical intervention.

02

Conditions studied

  • Esophageal Adenocarcinoma

Keywords

  • chemoradiation
  • consolidation chemotherapy
  • esophageal cancer
  • non-metastatic esophageal adenocarcinoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Chemoradiation with consolidative chemotherapy

    Participants will receive a standard course of chemoradiation followed by consolidative chemotherapy (FOLFOX regimen at the treating physician's discretion).

    Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

Interventions

  • DrugFOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

    Modified-FOLFOX-6 or FLOT (Fluorouracil, Leucovorin, Oxaliplatin, Docetaxel)

05

What researchers measure

Primary outcomes

  1. Number of participants with Clinical complete response (cCR)

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

    Time frame: approximately 36 weeks

Secondary outcomes

  1. Number of participants with pathologic complete response (pCR)

    Pathologic complete response (pCR) is defined as absence of detectable tumor of esophagectomy tissues.

    Time frame: approximately 36 weeks

  2. Number of participants who complete both chemoradiation and chemotherapy

    Time frame: approximately 36 weeks

  3. Number of participants with local control

    Local control in participants achieving clinical complete remission (cCR) estimated using the Kaplan-Meier method. cCR is defined as the disappearance of all detectable signs and symptoms of a disease, such as cancer, have completely disappeared.

    Time frame: up to 5 years

  4. Number of participants with Disease free survival

    Disease free survival in participants achieving cCR estimated using the Kaplan-Meier method. cCR is defined as the disappearance of all detectable signs and symptoms of a disease, such as cancer, have completely disappeared.

    Time frame: up to 5 years

  5. Time to distant metastasis

    Time to distant metastasis in participants achieving cCR estimated using the Kaplan-Meier method. cCR is defined as the disappearance of all detectable signs and symptoms of a disease, such as cancer, have completely disappeared.

    Time frame: up to 5 years

  6. Overall survival

    Measured in participants achieving cCR and estimated using the Kaplan-Meier method. cCR is defined as the disappearance of all detectable signs and symptoms of a disease, such as cancer, have completely disappeared.

    Time frame: up to 5 years

  7. Number of participants with Local control

    Measured in participants achieving pCR and estimated using the Kaplan-Meier method. pCR is defined as absence of detectable tumor of esophagectomy tissues.

    Time frame: up to 5 years

  8. Disease free survival

    Disease free survival in participants achieving pCR. pCR is defined as absence of detectable tumor of esophagectomy tissues.

    Time frame: up to 5 years

  9. Time to distant metastasis

    Time to distant metastasis in participants achieving pCR estimated using the Kaplan-Meier method. pCR is defined as absence of detectable tumor of esophagectomy tissues.

    Time frame: up to 5 years

  10. Overall survival

    Measured in participants achieving pCR and estimated using the Kaplan-Meier method. pCR is defined as absence of detectable tumor of esophagectomy tissues.

    Time frame: up to 5 years

06

Study locations

1 of 1 sites recruiting
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — Data may be shared 6 months after publication or as required by the journal

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07603375
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
May 22, 2026
Start date
Sep 2026 (estimated)
Primary completion
Aug 1, 2029 (estimated)
Completion
Feb 2034 (estimated)
Last update
Sep 29, 2026

Study contacts

Clinical Trials Office
Contact
RadOnc-Clinical_Trials@dm.duke.edu
(919) 668-3726
Manisha Palta, MD
principal investigator · Duke Health

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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