ClinicalTrials.gg
RecruitingNCT07603375TNT EsophagusUpdated Nov 4, 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 2026-11-04.

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

Updated Nov 4, 2026Now RecruitingStart date moved+3 moreGo to Updates ↓

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

Where this study stands

Counted across the records on this site · 2026-11-14

Among 246 studies in Adenocarcinoma Of Esophagus with a site in United States — 53 open to participants now, 73 under way, 7 of them phase 3. Adenocarcinoma Of Esophagus · United States.

Planned enrollment
83rd of 203
60 · median 49
Started
2026
with 14 others
Phase 2
125 of 246
17 open now
Primary completion
2029-09
later than 55 of 72 live
Registered
243rd of 246
by date

Among the 246 studies in Adenocarcinoma Of Esophagus with a site in United States, this one is the 83rd largest by planned enrollment of the 203 interventional ones that give a count, is one of 15 that started in 2026, is one of 125 in phase 2, reaches primary completion later than 55 of the 72 other live ones, and was the 243rd registered.

Adenocarcinoma Of Esophagus

354 studies on the registry are indexed under Adenocarcinoma Of Esophagus; 81 are open to participants now.

Browse Adenocarcinoma Of Esophagus studies →

Open to participants now

53 of the 246 studies in Adenocarcinoma Of Esophagus with a site in United States are open now. Recruiting first, the newest first:

47 more — sign in →

All 53 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 70 Adenocarcinoma Of Esophagus studies recruiting now, 60 (86%) set no upper age limit and 2 (3%) stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 246 studies in Adenocarcinoma Of Esophagus with a site in United States, or all of them as a file.
02

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.

03

Conditions studied

  • Esophageal Adenocarcinoma

Keywords

  • chemoradiation
  • consolidation chemotherapy
  • esophageal cancer
  • non-metastatic esophageal adenocarcinoma
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject must be able to provide study specific prior to study entry
  • Must be newly diagnosed, 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 disease must be obtained within 45 days of study enrollment
  • (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 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 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;
    • positive with \< 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 .
  • Has a history or current evidence of physical or physiological 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.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

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

06

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

07

Study locations

1 of 1 sites recruiting
08

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.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Sep 2029, 35 months after the start.

Of 51 non-industry phase 2 interventional studies under Adenocarcinoma Of Esophagus, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 82. This study's planned 35 months is below that.

Counting every sponsor, half of 60 studies reached it within 55 months; a quarter within 41 and three quarters within 80.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: start Sep 2026 → Oct 2026, primary completion Aug 2029 → Sep 2029 and completion Feb 2034 → Mar 2034.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
May 18, 2026
First posted
May 22, 2026
StartActual
Oct 21, 2026was Sep 2026
Primary completionEst.
Sep 21, 2029was Aug 2029
CompletionEst.
Mar 21, 2034was Feb 2034
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Sep 29, 2026
Sites
Duke University Medical Center is now Recruiting
Sep 29, 2026
Start date
Sep 2026→Oct 21, 2026 (actual)
Nov 4, 2026
Primary completion
Aug 1, 2029→Sep 21, 2029
Nov 4, 2026
Study completion
Feb 2034→Mar 21, 2034
Nov 4, 2026
Show all 2 updates
  1. Nov 4, 2026
    Start date Sep 2026→Oct 21, 2026 (now actual)
    Primary completion Aug 1, 2029→Sep 21, 2029
    Study completion Feb 2034→Mar 21, 2034
    + 1 other change: verification date
  2. Sep 29, 2026
    Not yet recruiting→Recruiting
    Duke University Medical Center is now Recruiting
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07603375
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
May 22, 2026
Start date
Oct 21, 2026
Primary completion
Sep 21, 2029 (estimated)
Completion
Mar 21, 2034 (estimated)
Last update
Nov 4, 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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Studies of the drug tested here: Folfox protocol

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