About this trial
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 Nitrogen Spray Cryotherapy (LNSC) in addition to chemotherapy versus chemotherapy alone in the treatment of esophageal adenocarcinoma. LNSC is an FDA approved device that works by using liquid nitrogen to rapidly cool cancerous tissue causing cell damage. Participants in this study will be randomly assigned to either the "LNSC group" or the "No-LNSC group." Participants in the "LNSC group" will undergo 2 sessions of LNSC through an upper endoscopy. Participants in the "No-LNSC group," may undergo an endoscopy if needed for symptoms such as difficulty swallowing. Participation in the research will last about 4 months.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Standard of care chemotherapy
- LNSC
Treatment groups
Sponsors and collaborators
Case Comprehensive Cancer Center
Lead sponsor
Salgi Foundation
Collaborator