MR-guided radiotherapy dose escalation for esophageal squamous cell carcinoma

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 is a phase 1, single-center trial using an MR-Linac to deliver adaptive radiotherapy with stepwise dose escalation alongside the CROSS neoadjuvant chemotherapy regimen for patients with resectable, locally advanced esophageal squamous cell carcinoma. Daily MRI guidance will be used to adapt treatment planning and better spare nearby organs while escalating radiation dose above the current neoadjuvant standard. The primary focus is on safety, tolerability, and feasibility of escalating dose with careful monitoring for acute and early late toxicity, and secondary data will include tumor response and pathologic complete response at surgery. Eligible tumors must be definable on baseline MRI, and patients proceed to planned esophagectomy after completion of chemoradiotherapy per standard care. All treatment and follow-up are conducted at University Medical Center Utrecht.

Why it matters

Who can join: the full rules

Inclusion criteria

In order to be eligible for this study, a subject must meet all of the following criteria:

* Histologically confirmed squamous cell carcinoma of the esophagus or GE- junction (Siewert I/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
* Scheduled to receive neoadjuvant chemoradiotherapy according to CROSS-regimen: weekly administration of carboplatin and paclitaxel for 5 weeks and concurrent radiotherapy (41.4Gy in 23 fractions, 5 days per week), followed by esophagectomy (as judged by the multidisciplinary tumor board)
* 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)
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion criteria

A subject who meets any of the following criteria will be excluded from participation in this study:

* Adenocarcinoma of the esophagus
* Non-resectable, inoperable or metastatic squamous cell carcinoma of the esophagus or GE-junction
* Siewert type III
* Squamous cell carcinoma of the cervical esophagus
* 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
* Irradical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of primary tumor prior to start of neoadjuvant chemoradiotherapy
* Pregnant or breast-feeding patients
* 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Neoadjuvant CTLA-4 and PD-1 blockade with chemoradiotherapy for locally advanced ESCC

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• PD-1 inhibitors with local therapy at different timings in oligometastatic ESCC

  This study tests whether giving local radiotherapy at different times around PD-1 inhibitor therapy helps people with oligometastatic esophageal squamous cell carcinoma.

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• Adebrelimab plus chemotherapy before surgery for borderline-resectable esophageal squamous cell carcinoma

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• Adebrelimab with neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma

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• Starting chemo plus PD-1 immunotherapy before radiation versus giving chemo during radiation for unresectable locally advanced esophageal squamous cell carcinoma

  This trial sees if giving three cycles of chemotherapy with a PD-1 immunotherapy before radiation, followed by maintenance immunotherapy, works better than giving chemotherapy at the same time as radiation followed by the same maintenance for people with unresectable locally advanced esophageal squamous cell carcinoma.

  Recruiting Phase 2 Second Affiliated Hospital of Zunyi Medical University · Zunyi, Guizhou · NCT07559045

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.