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Esophageal AdenocarcinomaPhase 2TNT EsophagusNCT07603375

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

A Phase 2 study testing FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) in people with Esophageal Adenocarcinoma, run by Duke University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Adenocarcinoma
What is being tested?
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Sep 2026to Feb 2034
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Office contact

(919) 668-3726

RadOnc-Clinical_Trials@dm.duke.edu

United States1 site, 1 recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Kaitlin Bailey, RN BSN OCN, (919) 668-3726, RadOnc-Clinical_Trials@dm.duke.edu

    Manisha Palta, MD

    Recruiting

Other trials in United States

About this study

Official title: A Single-arm Study of Upfront Chemotherapy With Radiation Therapy (CRT) Followed by Chemotherapy in Localized Esophageal Adenocarcinoma

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.

Being tested
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
Keywords
chemoradiation, consolidation chemotherapy, esophageal cancer, non-metastatic esophageal adenocarcinoma
Medical subject headings
Adenocarcinoma Of Esophagus, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT07603375
Study groupRoleWhat they receive
Chemoradiation with consolidative chemotherapyExperimentalParticipants will receive a standard course of chemoradiation followed by consolidative chemotherapy (FOLFOX regimen at the treating physician's discretion).
Receives: Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: approximately 36 weeks

Secondary outcomes (10)

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

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

    Measured: approximately 36 weeks

  2. Number of participants who complete both chemoradiation and chemotherapy

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study startSep 2026 (estimated)
  3. Primary completion1 Aug 2029 (estimated)
  4. Study completionFeb 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07603375
Sponsor's protocol ID
Pro00120182
Acronym
TNT Esophagus
Status last verified
Sep 2026
First submitted
18 May 2026
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Data may be shared 6 months after publication or as required by the journal

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) in people with Esophageal Adenocarcinoma, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Office ((919) 668-3726, RadOnc-Clinical_Trials@dm.duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Clinical complete response (cCR) (time frame: approximately 36 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07603375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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