Status:
NOT_YET_RECRUITING
Liquid Nitrogen Spray Cryotherapy Prior to Neoadjuvant Systemic Therapy in Esophageal Adenocarcinoma
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
Salgi Foundation
Conditions:
Esophageal Adenocarcinoma
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This research study is for people who have locally advanced esophageal adenocarcinoma and are expected to receive chemotherapy. The purpose of this study is to compare the effectiveness of Liquid Nitr...
Detailed Description
People with locally advanced esophageal adenocarcinoma (a type of cancer in the esophagus) often have trouble swallowing because of the tumor's size and spreading to nearby areas. Doctors diagnose and...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07222657
Start Date
November 1 2025
End Date
September 1 2027
Last Update
October 31 2025
Active Locations (1)
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1
Cleveland Clinic Florida
Weston, Florida, United States, 33331