Chemotherapy plus adaptive MR-guided radiotherapy for esophageal adenocarcinoma
Combination of Chemotherapy and Adaptive MR-Guided Radiotherapy to Improve Outcomes in Patients With Esophageal Adenocarcinoma (MERGE): A Phase 1 Dose-Finding Trial
PHASE1 · UMC Utrecht · NCT07359443
This Phase 1 trial will see if adding adaptive MR-guided radiotherapy to perioperative chemotherapy (FLOT) before surgery helps adults with resectable esophageal or gastroesophageal junction adenocarcinoma.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Utrecht, Utrecht) |
| Trial ID | NCT07359443 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed, potentially resectable esophageal or Siewert I–II gastroesophageal junction adenocarcinoma, tumor ≤10 cm, WHO performance status 0–2, eligible for perioperative FLOT and MRI-based planning are ideal candidates.
Not a fit: Patients with squamous cell carcinoma, unresectable or metastatic disease, Siewert type III tumors, prior mediastinal radiotherapy, prior esophageal surgery that prevents esophagectomy, or contraindications to MRI are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could improve tumor control and increase rates of complete resection or pathological response while reducing radiation exposure to normal tissues.
How similar studies have performed: Neoadjuvant chemoradiotherapy such as the CROSS regimen improved outcomes historically but showed lower pathologic complete response in adenocarcinoma, and MR-guided adaptive radiotherapy is an emerging technique with promising early results in other sites but limited specific data for esophageal adenocarcinoma.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Utrecht, Utrecht
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Esophageal Adenocarcinoma, Adenocarcinoma - Gastroesophageal Junction, MR-Guided Radiotherapy, Adaptive Radiotherapy, MR-Linac, Dose Escalation, Phase 1 Trial