Liquid Nitrogen Spray Cryotherapy Prior to Neoadjuvant Systemic Therapy in Esophageal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Standard of care chemotherapy
Other interventionParticipants will receive neoadjuvant therapy per FLOT protocol +/- Durvalumab for up to 6 cycles. Each cycle is two weeks. The FLOT protocol is a standard of care protocol involving chemotherapy before and after esophagectomy with fluorouracil, leucovorin, oxaliplatin, and docetaxel. Durvalumab is administered intravenously (IV) and dosed at 1500 milligrams (mg). It is given on Day 1 of each cycle.
LNSC
Procedure/SurgeryLNSC will be administered via endoscopy. LNSC will be performed with liquid nitrogen (\<5 psi) at 25 watts using a cryotherapy catheter passed through the working channel of the endoscope. Up to three cycles of 20 to 40 seconds of cryotherapy will be administered and each directed at the bulkiest aspect of the tumor. During each cycle, a surface area of approximately 2 to 3 cm2 is targeted, and up to three sites are targeted during each session. Participants will receive two sessions of LNSC. The first will be upon entry into the study. The second will be 1-2 weeks after the first session.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Liquid Nitrogen Spray Cryotherapy (LNSC) + Standard of care chemotherapyExperimental treatment 2 interventions
Group B: Standard of care chemotherapyOther 1 intervention
Trial outcomes
Primary outcomes
1
Complete response (CR) rates
CR is defined as the absence of tumor on re-staging scans and explant or mucosal biopsies (if applicable).
Time frame
At treatment discontinuation, up to 12 weeksSecondary outcomes
1
Change in minimal residual disease (MRD)
MRD is defined using the Signatera assay as any detectable circulating tumor DNA (ctDNA)
Time frame
Week 4 of chemotherapy, 2-4 weeks post-chemotherapy (up to 16 weeks)2
Overall survival (OS)
Overall survival (OS) is defined as the duration of time from start of treatment to time of death from any cause.
Time frame
1 year3
Change in systemic immune response
Systemic immune response will be measured through cellular immune profiling (e.g., CD4+, CD8+, cytotoxic T cells, FOXP3+ regulatory T cells) via centralized flow cytometry.
Time frame
Baseline, 4 weeks post-chemotherapy, up to 16 weeks4
Change in dysphagia
Dysphagia is measured by a Dysphagia Questionnaire containing 5 questions. Participants answer 3 questions with yes/no answer choices that refer to if they have had trouble swallowing. Participants answer 1 question regarding severity of dysphagia with 4 answer choices ranging from "Doesn't bother me at all" to "Very severe." Participants answer 1 question regarding frequency of dysphagia with answer choices ranging from "None" to "Unable to eat." Participants answer 1 question regarding the type of items that have trouble swallowing with answer choices being "Both solids and liquids," "Solid foods only," or "Liquids only." Answers are qualitatively assessed for severity and frequency of dysphagia.
Time frame
Baseline, up to 2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Case Comprehensive Cancer Center
Lead sponsor
Salgi Foundation
Collaborator
Source ClinicalTrials.gov