Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2026-01-04 @ 1:44 AM
Study NCT ID:
NCT03285035
Status:
UNKNOWN
Last Update Posted:
2019-10-11
First Post:
2017-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life Assessment of Cryotherapy in Esophageal or Gastroesophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017679', 'term': 'Cryotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Archival tissue or fresh tissue from gastrointestinal biopsies used for diagnostic purposes.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-01-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-08', 'studyFirstSubmitDate': '2017-08-28', 'studyFirstSubmitQcDate': '2017-09-12', 'lastUpdatePostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 6 months compared to baseline', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Change in dysphagia score using the 5 point Likert scale at 1 to 2 weeks post-procedure compared to baseline', 'timeFrame': '1 to 2 weeks'}, {'measure': 'Number of participants with adverse events as assessed by CTCAE 4.03.', 'timeFrame': '30 days'}, {'measure': 'Number of participants requiring alternative treatments for dysphagia palliation such as stenting, photodynamic therapy or brachytherapy and stenting', 'timeFrame': '1 year'}, {'measure': 'Subjective Global Assessment scale of nutritonal status will be determined at baseline and approximately 3 month intervals.', 'timeFrame': '1 year'}, {'measure': 'Tumor length in centimeters, endoscopist estimated luminal diameter and endoscopist subjective assessment of size as compared to the prior endoscopy will be determined', 'timeFrame': '1 to 12 weeks'}, {'measure': 'Immunoassays will be obtained before and after treatment', 'timeFrame': '1 year'}, {'measure': 'local tumor control will be compared to systemic tumor control', 'timeFrame': '1 year'}, {'measure': 'Survival while on cryotherapy and systemic chemotherapy will be measured.', 'timeFrame': '1 year'}, {'measure': 'Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 1 to 2 weeks compared to baseline', 'timeFrame': '1 year'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cryotherapy', 'Palliation', 'Dysphagia'], 'conditions': ['Esophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '37268010', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Cryoablation combined with chemotherapy on the quality of life of patients with non resectable esophageal or gastroesophageal cancer.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with non resectable esophageal cancer', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has esophageal or gastroesophageal cancer and will be receiving chemotherapy\n* Dysphagia score of 1, 2, 3 or 4.\n* Age ≥18 years old\n* American Society of Anesthesiologists (ASA) Physical Status Classification ≤ 4\n* Deemed not a candidate for esophageal cancer surgical resection\n* 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\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status greater than 2\n* Patient who received radiation treatment in the prior 8 weeks\n* Known brain metastases causing cranial nerve deficits which can cause dysphagia\n* Inability to undergo an esophagogastroduodenoscopy (EGD)\n* Pregnant or nursing\n* Surgery or anatomy where capacity of stomach is reduced making cryotherapy contraindicated\n* Patients with tracheoesophageal fistula'}, 'identificationModule': {'nctId': 'NCT03285035', 'acronym': 'Cryotherapy', 'briefTitle': 'Quality of Life Assessment of Cryotherapy in Esophageal or Gastroesophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Western Regional Medical Center'}, 'officialTitle': 'Quality of Life Assessment in Patients Receiving Cryotherapy in Addition to Chemotherapy for Palliation of Unresectable Esophageal or Gastroesophageal Cancer', 'orgStudyIdInfo': {'id': 'WG2015029'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-operable esophageal cancer', 'description': 'Cryotherapy treatment', 'interventionNames': ['Device: Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.']}], 'interventions': [{'name': 'Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.', 'type': 'DEVICE', 'description': 'Upper endoscopy with cryotherapy using liquid nitrogen.', 'armGroupLabels': ['Non-operable esophageal cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85338', 'city': 'Goodyear', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Toufic Kachaamy, MD', 'role': 'CONTACT', 'email': 'WesternTrials@ctca-hope.com', 'phone': '623-207-3000'}], 'facility': 'Western Regional Medical Center, Inc.', 'geoPoint': {'lat': 33.43532, 'lon': -112.35821}}], 'centralContacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'WesternTrials@ctca-hope.com', 'phone': '623-207-3000'}, {'name': 'Research Nurse, RN', 'role': 'CONTACT', 'email': 'WesternTrials@ctca-hope.com', 'phone': '623-207-3000'}], 'overallOfficials': [{'name': 'Toufic Kachaamy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western Regional Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Regional Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}