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Combination of Chemotherapy and Adaptive MR-Guided Radiotherapy to Improve Outcomes in Patients With Esophageal Adenocarcinoma

RecruitingPhase 1Ages 18 Years - anyAllUMC Utrecht
NCT07359443 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Rationale: Esophageal cancer (EC) is the seventh most frequently diagnosed cancer and the sixth leading cause of cancer-related death worldwide. As a result of the late onset of symptoms, most patients with EC present in an advanced stage with a corresponding poor prognosis. Poor disease outcome after surgery alone (5-yr overall survival between 25-40%) prompted many researchers to explore neoadjuvant chemoradiotherapy (nCRT) or neoadjuvant or perioperative chemotherapy (nCT/pCT) approaches. In the Netherlands, neoadjuvant chemoradiation has become standard of care for esophageal cancer since publication of the CROSS trial showing a benefit of nCRT over surgery alone for both adenocarcinoma (AC) and squamous cell carcinoma (SCC) (van Hagen et al., 2012). However, the benefit of nCRT was less pronounced in AC, which was also reflected by pathologic complete response (pCR) rates: 23% in A

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📋 Eligibility rules (as published)
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)
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What it tests

  • MRI guided radiotherapy
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Where

1 site
University Medical Center Utrecht
Utrecht, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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