Upfront Chemotherapy With Radiation Therapy (CRT) Followed by Chemotherapy in Localized Esophagea… (NCT07603375) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Upfront Chemotherapy With Radiation Therapy (CRT) Followed by Chemotherapy in Localized Esophageal Adenocarcinoma
United States60 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 an…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with Clinical complete response (cCR)