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

NCT07603375 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: Pro00120182
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Adenocarcinoma

Keywords

chemoradiation; consolidation chemotherapy; esophageal cancer; non-metastatic esophageal adenocarcinoma

Outcome Measures

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

  approximately 36 weeks

Secondary Outcomes (10)

• Number of participants with pathologic complete response (pCR)

  approximately 36 weeks

• Number of participants who complete both chemoradiation and chemotherapy

  approximately 36 weeks

• Number of participants with local control

  up to 5 years

• Number of participants with Disease free survival

  up to 5 years

• Time to distant metastasis

  up to 5 years

Study Arms (1)

chemoradiation with consolidative chermotherapy

EXPERIMENTAL

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

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

Interventions

FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) DRUG

modified-FOLFOX-6 or FLOT

chemoradiation with consolidative chermotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus; Esophageal Neoplasms

Interventions

Folfox protocol; Fluorouracil; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Study Officials

• Manisha Palta, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Office

CONTACT

(919) 668-3726; RadOnc-Clinical_Trials@dm.duke.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): February 1, 2034
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)