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Cryotherapy for Esophageal Cancer

Phase 1
Waitlist Available
Led By Tilak Shah, MD
Research Sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients with locally advanced esophageal cancer will be eligible to participate in the study. Eligible patients must have a histologically proven diagnosis of esophageal adenocarcinoma, esophageal squamous cell carcinoma, adenosquamous carcinoma, or gastro-esophageal junctional adenocarcinoma. Locally advanced esophageal cancer will be defined as absence of distant metastases on positron emission tomography-computed tomography (PET-CT) and a TNM stage of IIA to IIIC, as defined by endoscopic ultrasound and PET-CT
Histologically proven diagnosis of esophageal adenocarcinoma, esophageal squamous cell carcinoma, adenosquamous carcinoma, or gastro-esophageal junctional adenocarcinoma
Must not have
Pediatric patients (age less than 18 years)
Superficial esophageal cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

This trial is testing the safety of using liquid nitrogen to freeze and kill cancer cells in people with esophageal cancer.

Who is the study for?
Adults with locally advanced esophageal cancer, confirmed by specific tests and without distant metastases. They must be able to undergo procedures required for the trial and not have severe coagulopathy, a very poor performance status (ECOG ≥3), or be pregnant.
What is being tested?
The study is testing Liquid Nitrogen Spray Cryotherapy (LNSC) given before and during standard chemoradiation therapy. It aims to find the highest dose patients can take without serious side effects and see if LNSC helps the immune system fight cancer better.
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, changes in swallowing ability due to inflammation or damage from freezing tissue, bleeding risks especially in those with clotting issues, and general reactions like fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have esophageal cancer without spread to distant parts, confirmed by tests.
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My cancer is one of the specified types affecting the esophagus or where the stomach meets the esophagus.
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I have advanced cancer in my esophagus.
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My esophageal cancer is advanced but hasn't spread to distant parts of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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My cancer is located in the early stages of the esophagus.
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I cannot have a tube passed into my stomach through my mouth.
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I need considerable assistance and am unable to do any work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose limiting toxicity (DLT)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cryotherapy before chemoradiation and duringExperimental Treatment1 Intervention
Patients receive 2 sessions of liquid nitrogen spray cryotherapy prior to chemoradiation and one session during chemoradiation
Group II: Cryotherapy before chemoradiationExperimental Treatment1 Intervention
Patients receive 2 sessions of liquid nitrogen spray cryotherapy prior to chemoradiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryotherapy
2011
Completed Phase 4
~2280

Find a Location

Who is running the clinical trial?

Hunter Holmes Mcguire Veteran Affairs Medical CenterLead Sponsor
36 Previous Clinical Trials
21,592 Total Patients Enrolled
McGuire Research InstituteOTHER
9 Previous Clinical Trials
367 Total Patients Enrolled
Tilak Shah, MDPrincipal Investigator - McGuire VA Medical Center
Hunter Holmes Mcguire Veteran Affairs Medical Center
~3 spots leftby Sep 2025
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