← Back to Search

Other

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have esophageal cancer without spread to distant parts, confirmed by tests.

Select...

My cancer is one of the specified types affecting the esophagus or where the stomach meets the esophagus.

Select...

I have advanced cancer in my esophagus.

Select...

My esophageal cancer is advanced but hasn't spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hunter Holmes Mcguire Veteran Affairs Medical CenterLead Sponsor

35 Previous Clinical Trials

21,537 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there recruitment opportunities for this research project?

"Unfortunately, the data available from clinicaltrials.gov reveals that this research study has ceased recruitment of participants since its last update on January 29th 2020. However, there are still 375 other trials actively looking for enrollees at this present time."

Answered by AI