Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT06037902
Status:
RECRUITING
Last Update Posted:
2023-09-14
First Post:
2023-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CPAP for Esophageal Cancer With Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'all patients undergo two simulations.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-13', 'studyFirstSubmitDate': '2023-08-28', 'studyFirstSubmitQcDate': '2023-09-13', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'absolute mean heart radiation dose', 'timeFrame': 'on day of simulation (day 1)', 'description': 'measured in Gy'}], 'secondaryOutcomes': [{'measure': 'lung dose in Gy', 'timeFrame': 'on day of simulation (day 1)', 'description': 'mean lung dose, V5 and V20'}, {'measure': 'heart dose in Gy', 'timeFrame': 'on day of simulation (day 1)', 'description': 'mean heart dose, V30'}, {'measure': 'movement of tumor in cm', 'timeFrame': 'on day of simulation (day 1)', 'description': 'how much tumor moves with breathing'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radiation'], 'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test the use of CPAP in patients with esophgaeal cancer undergoing radiotherapy.\n\nThe main questions it aims to answer are:\n\n* does use of CPAP decrease exposure of normal lung to radiation?\n* does use of CPAP decrease exposure of normal heart to radiation?\n\nParticipants will undergo simulation twice:\n\n* with CPAP\n* without CPAP'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of cancer, with a tumor (primary or secondary) in the esophagus including tumors in the esophagus-stomach junction.\n2. Age ≥ 18\n3. Planned RT treatment\n4. The level of functioning ≥ 60 on the Karnofsky scale\n5. Life expectancy ≥ two months\n6. All patients must understand the informed consent form document and sign it of their own free will before any test/procedure related to the study is performed.\n7. Able to undergo simulation and radiation with CPAP\n8. Candidate patients can be recruited to receive definitive, palliative or pre-operative radiation, with or without chemotherapy.\n\nExclusion Criteria:\n\nA person who meets any of the following exclusion criteria will not be able to participate in the study:\n\n1. Pregnancy or breastfeeding\n2. Significant comorbidity at the starting point that would prevent the use of CPAP\n3. Hospitalized in an institution by virtue of an administrative order or a court order.\n4. Special population\n5. A history of a psychiatric problem that may impair the patient's ability to understand the research requirements or respond to them, or to give his consent"}, 'identificationModule': {'nctId': 'NCT06037902', 'acronym': 'TROS-7', 'briefTitle': 'CPAP for Esophageal Cancer With Radiotherapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Use of CPAP (Continuous Positive Airway Pressure) for Simulating Esophageal Cancer Patients Prior to Radiotherapy', 'orgStudyIdInfo': {'id': 'SHEBA-22-0032-YL-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPAP', 'description': 'patients will undergo simulation twice, with and without CPAP', 'interventionNames': ['Device: CPAP']}], 'interventions': [{'name': 'CPAP', 'type': 'DEVICE', 'description': 'patients undergo simulation twice, with and without CPAP', 'armGroupLabels': ['CPAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yaacov R Lawrence, MBBS MA MRCP', 'role': 'CONTACT', 'email': 'Yaacov.Lawrence@sheba.health.gov.il', 'phone': '97235304410'}, {'name': 'Aliza Ackerstein', 'role': 'CONTACT', 'email': 'aliza.ackerstein@sheba.health.gov.il', 'phone': '035308402'}, {'name': 'Yaacov R Lawrence, MBBS MA MRCP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair of Department of Radiation Oncology, principal investigator', 'investigatorFullName': 'Dr. Yaacov Lawrence', 'investigatorAffiliation': 'Sheba Medical Center'}}}}