Liquid nitrogen spray cryotherapy before chemotherapy for locally advanced esophageal cancer

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 2 trial compares two approaches in adults with locally advanced esophageal adenocarcinoma: standard chemotherapy with or without two sessions of liquid nitrogen spray cryotherapy delivered via upper endoscopy. Participants are randomly assigned to receive LNSC in addition to chemotherapy or to receive chemotherapy alone, with follow-up over about four months. The study aims to see if the added cryotherapy improves tumor response and potentially survival, recognizing that complete responses to neoadjuvant therapy are relatively infrequent. LNSC works by delivering extreme cold to destroy cancerous tissue, potentially enhancing effectiveness of systemic therapy. Eligible patients include those with specific TNM stages and planned FLOT-based regimens, while certain medical conditions and procedures exclude participation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults with locally advanced EAC who are expected to receive FLOT +/-Durvalumab will be eligible to participate.
* Locally advanced esophageal cancer is defined as TNM stages T1N+M0 or T2-T4aNanyM0, as defined by endoscopic ultrasound (EUS) and PET-CT.

Exclusion Criteria:

* Inability to pass the orogastric decompression tube into the stomach
* Coagulopathy (INR \> 2 or platelet count \< 50,000 per cubic millimeter)
* Inability to provide informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status \> 2
* Risk of thrombosis is determined to be too high to hold anti-platelets (other than aspirin) or anticoagulants prior to the procedure.

Where it's running

• Cleveland Clinic Florida
  Weston, Florida, United States Recruiting

Study contacts

• Principal investigator: Tilak Shah, MD — Case Comprehensive Cancer Center, Cleveland Clinic Florida
• Study coordinator: Tilak Shah, MD
• Email: shaht3@ccf.org
• Phone: 561-497-8859

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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.