Quality of Life Assessment of Cryotherapy in Esophageal or Gastroesophageal Cancer

Study Overview
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Brief Summary
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Cryoablation combined with chemotherapy on the quality of life of patients with non resectable esophageal or gastroesophageal cancer.

Detailed Description
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This is a single arm prospective study to determine the effect of cryoablation combined with chemotherapy on the quality of life of patients with non resectable esophageal or gastroesophageal cancer.

Official Title
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Quality of Life Assessment in Patients Receiving Cryotherapy in Addition to Chemotherapy for Palliation of Unresectable Esophageal or Gastroesophageal Cancer

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Device: Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has esophageal or gastroesophageal cancer and will be receiving chemotherapy Dysphagia score of 1, 2, 3 or 4. Age ≥18 years old American Society of Anesthesiologists (ASA) Physical Status Classification ≤ 4 Deemed not a candidate for esophageal cancer surgical resection Female subjects must be either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e., total abstinence, birth control pills, an intrauterine device (IUD), diaphragm, progesterone injections or implants, or condoms plus a spermicide) for the duration of the study Exclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status greater than 2 Patient who received radiation treatment in the prior 8 weeks Known brain metastases causing cranial nerve deficits which can cause dysphagia Inability to undergo an esophagogastroduodenoscopy (EGD) Pregnant or nursing Surgery or anatomy where capacity of stomach is reduced making cryotherapy contraindicated Patients with tracheoesophageal fistula

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-operable esophageal cancer<br>Cryotherapy treatment | Device: Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.<br>* Upper endoscopy with cryotherapy using liquid nitrogen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 6 months compared to baseline |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dysphagia score using the 5 point Likert scale at 1 to 2 weeks post-procedure compared to baseline |  | 1 to 2 weeks | 
| Number of participants with adverse events as assessed by CTCAE 4.03. |  | 30 days | 
| Number of participants requiring alternative treatments for dysphagia palliation such as stenting, photodynamic therapy or brachytherapy and stenting |  | 1 year | 
| Subjective Global Assessment scale of nutritonal status will be determined at baseline and approximately 3 month intervals. |  | 1 year | 
| Tumor length in centimeters, endoscopist estimated luminal diameter and endoscopist subjective assessment of size as compared to the prior endoscopy will be determined |  | 1 to 12 weeks | 
| Immunoassays will be obtained before and after treatment |  | 1 year | 
| local tumor control will be compared to systemic tumor control |  | 1 year | 
| Survival while on cryotherapy and systemic chemotherapy will be measured. |  | 1 year | 
| Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 1 to 2 weeks compared to baseline |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryotherapy, Palliation, Dysphagia