New combo may let esophageal cancer patients skip surgery
NCT ID NCT07603375
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This study tests whether giving additional chemotherapy after the usual chemoradiation can better control esophageal cancer and reduce the need for surgery. About 60 adults with stage II to IVA esophageal adenocarcinoma will receive chemoradiation followed by more chemotherapy. The main goal is to see if the cancer disappears on biopsy after treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2034
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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Other studies related to the condition(s) this trial covers.
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