trūFreeze® Palliative Esophageal Cancer

Study Overview
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Brief Summary
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Prospective, open label, non-controlled single arm, multi-center study The primary objective is to study the effects of the trūFreeze® Spray Cryotherapy System in a population of subjects who have been diagnosed with persistent local esophageal cancer and who are not surgical candidates or have completed or declined systemic therapy.

Detailed Description
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The use of cryotherapy delivered with the trūFreeze® System via noncontact spray ablates the cancer cells while allowing adjacent normal tissue to regenerate. When the liquid nitrogen is delivered to the malignant lesion the cancer cells undergo ablation induced by intracellular water being frozen in place such that ice crystals are formed. These ice crystals aggregate quickly causing immediate intracellular energy producing organelles to be destroyed leading to a non-viable cell. Subsequent tumor sloughing and absorption of apoptotic cells occurs with a subsequent debulking of the tumor mass. Normal tissue will regenerate as re-epithelialization occurs. The extreme cold of -196 degrees Celsius or a hard freeze leads to more extensive primary cell death over a shorter freeze time as compared to cryoprobes. A reduction of overall tumor obstruction in the esophageal lumen can reduce symptoms of dysphagia, delay the time until stent is needed, provide palliative care for patients for whom additional tri-modal therapies are not an option, and may increase quality of life in esophageal cancer patients. The studies conducted to date have provided documentation of the safety and effectiveness of spray cryotherapy (SCT) when used for malignancies in the esophagus. Measures of dysphagia relief have been described in peer reviewed literature. This study aims to provide much needed HRQOL information as well as additional tumor characteristics before and after SCT. A cohort of patients with locally persistent esophageal cancer will be studied in up to twelve (12) centers in the United States to provide important HRQOL data and more a comprehensive understanding of clinical tumor response post SCT. In the proposed study, the trūFreeze® System spray cryotherapy procedure will be performed during endoscopy. Each SCT procedure will be performed endoscopically at clinically indicated intervals of 6 weeks +/- 3 weeks. Total procedure dosimetry will be delivered at the discretion of the Investigator based on tumor location and patient tolerability. After each procedure at defined intervals, patients will be contacted and QOL symptom related information will be collected. If at any point an Investigator determines that a subject is not a candidate for further spray cryotherapy or is unable to tolerate additional procedures, they will be contacted via telephone to ascertain HRQOL information. Subject participation will last up to two years or until death

Official Title
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A Prospective Single Arm Multicenter Study Evaluating the Effects of Spray Cryotherapy in Patients With Persistent Local Esophageal Cancer

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Device: trūFreeze® System spray cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females of 18 to 89 years of age. Subject is able to read, understand, and sign a written Informed Consent to participate in the study. Subject has persistent esophageal cancer with local luminal involvement and who is not a surgical candidate or has completed or declined systemic therapy. Subject is able to tolerate endoscopy Exclusion Criteria: Subject is pregnant, nursing, or planning to get pregnant during study duration. Subjects with an esophageal stent in situ at the time of study enrollment Subject, as deemed by treating investigator has contraindication to endoscopy or Spray Cryotherapy Procedure. Subject has received radiation within the past 6 weeks Subject has received chemotherapy within the past 2 weeks Subject has received immunotherapy within 30 days Subject has participated in another clinical study for systemic therapy within 6 weeks of baseline. Subject has had previous Spray Cryotherapy for esophageal cancer.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: trūFreeze® System spray cryotherapy<br>trūFreeze® System spray cryotherapy as clinically indicated for symptom relief | Device: trūFreeze® System spray cryotherapy<br>* Subjects where trūFreeze® System spray cryotherapy is performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline EORTC at 14 days post cryotherapy procedure | Validated Cancer Specific Quality of Life Questionnaire | 14 days post spray cryotherapy | 
| Change from baseline dysphagia scale at 14 days post cryotherapy procedure | Dysphagia Severity Scale | 14 days post spray cryotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to additional interventional procedure(s) other than spray cryotherapy (e.g. stent placement) | baseline to procedure other than spray cryotherapy | up to 2 years post SCT procedure | 
| Overall Survival | SCT to death | up to 2 years post SCT procedure | 
| Mean change in the amount of residual tumor from baseline to follow-up cryospray delivery session | Describe changes in tumor | up to 2 years post SCT procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spray cryotherapy, quality of life, symptom reduction, esophageal malignancies, liquid nitrogen, ablation