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Cryoablation combined with chemotherapy on the quality of life of patients with non resectable esophageal or gastroesophageal cancer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-operable esophageal cancer | Cryotherapy treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation. | Device | Upper endoscopy with cryotherapy using liquid nitrogen. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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patients with non resectable esophageal cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | 623-207-3000 | WesternTrials@ctca-hope.com | |
| Research Nurse, RN | Contact | 623-207-3000 | WesternTrials@ctca-hope.com |
| Name | Affiliation | Role |
|---|---|---|
| Toufic Kachaamy, MD | Western Regional Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Regional Medical Center, Inc. | Recruiting | Goodyear | Arizona | 85338 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37268010 | Derived | Kachaamy T, Sharma N, Shah T, Mohapatra S, Pollard K, Zelt C, Jewett E, Garcia R, Munsey R, Gupta S, Rojas-DeLeon M, Gupta D, Kaul V, Pannala R, Vashi P. A prospective multicenter study to evaluate the impact of cryotherapy on dysphagia and quality of life in patients with inoperable esophageal cancer. Endoscopy. 2023 Oct;55(10):889-897. doi: 10.1055/a-2105-2177. Epub 2023 Jun 2. |
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Archival tissue or fresh tissue from gastrointestinal biopsies used for diagnostic purposes.
| 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 |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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