Chemotherapy plus adaptive MR-guided radiotherapy for esophageal adenocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, single-center trial at UMC Utrecht combines perioperative chemotherapy (FLOT) with adaptive MR-guided radiotherapy delivered on an MR-Linac for patients with resectable esophageal or gastroesophageal junction adenocarcinoma. Treatment uses MRI-derived anatomy (T2-weighted and diffusion-weighted sequences) to adapt radiotherapy plans and escalate dose while aiming to limit toxicity to surrounding organs. Eligible patients have clinically staged potentially resectable disease (cT1bN+, cT2-3 N0-3 M0) and are planned for esophagectomy after neoadjuvant therapy. The primary focus is safety, feasibility, and defining tolerable radiation dose levels prior to larger efficacy studies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the esophagus or GE- junction (Siewert I or II)
* Potentially resectable, locally advanced esophageal tumor (cT1bN+, cT2-3, N0-3, M0) based on standard primary staging by EUS and 18F-FDG PET-CT
* Eligible for neoadjuvant treatment: followed by esophagectomy (as judged by the multidisciplinary tumor board)
* Eligible for pCT FLOT
* Tumor length ≤ 10 cm
* Age ≥ 18 years
* WHO performance status 0-2
* Signed informed consent
* Tumor volume that can be defined on MRI at baseline (T2w and DW-MRI)
* Written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

* Squamous cell carcinoma
* Non-resectable, inoperable or metastatic adenocarcinoma of the esophagus or GE junction
* Siewert type III tumors
* Prior (chemo)radiotherapy to the mediastinum
* Prior esophageal surgery that impedes the ability to perform an esophagectomy
* Patients with multiple primary carcinomas of the esophagus
* Patients who meet exclusion criteria for MRI according to the MRI contraindications screening list of the imaging and oncology division of the UMC Utrecht

  \* Irradical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of primary tumor prior to start of neoadjuvant chemoradiotherapy
* Pregnant or breast-feeding patients
* Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule before patient registration. Patients in whom it is not in their best interest to participate (in the judgment of the PI)

Where it's running

• University Medical Center Utrecht
  Utrecht, Utrecht, Netherlands Recruiting

Study contacts

• Study coordinator: drs. Sanders, MD
• Email: MRGuidedRTSlokdarm@umcutrecht.nl
• Phone: +31 (0)88-755-5555

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.