Using imaging to identify sensitive esophageal cancer for better treatment

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 observational trial investigates the use of advanced FDG-PET imaging parameters to identify squamous cell carcinomas of the esophagus that are highly sensitive to chemoradiation therapy. The study aims to validate biomarkers that could allow for more personalized treatment approaches, such as organ preservation for patients who respond well to therapy. Key endpoints include event-free survival and quality of life assessments, with additional focus on genetic sequencing to optimize future treatments for non-responders. The trial includes patients with various stages of esophageal cancer undergoing definitive chemoradiation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* patients with squamous cell, undifferentiated or adenocarcinoma of the esophagus, UICC stage II-IVA (maximum T4a)
* ECOG performace status 0-2
* Complete clinical staging, including, esophagogastroscopy, EUS, CT neck/thorax/abdomen and adequate pulmonary function.
* Adequate hematological, renal, hepatic and pulmonary functions defined as:

granulocytes ≥ 1.5 x 109/l platelets ≥ 100 x 109/l total bilirubin ≤ 1.5 x upper normal limit creatinine ≤ 120 μmol/L FEV1 ≥ 1.5 L

* Written, voluntary informed consent
* Willingness to perform effective contraceptive practices during treatment for patients with childbearing potential

Exclusion Criteria:

* Evidence of distant metastases (cM1)
* Prior high-dose radiotherapy to the thorax or abdomen
* Primary tumor cT4b
* history or concurrent malignancy as judged by the treating physician. This is only an exclusion criterion if the other malignancy is considered the oncological potentially leading cause of death compared to the esophageal cancer.

Where it's running

• Charité Universitätsmedizin Berlin
  Berlin, Germany Recruiting

Study contacts

• Principal investigator: Sebastian Zschaeck, MD — Charite University, Berlin, Germany
• Study coordinator: Sebastian Zschaeck, MD
• Email: sebastian.zschaeck@charite.de
• Phone: ++4930450650764

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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.