Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-28 @ 8:59 PM
Study NCT ID:
NCT03804203
Status:
UNKNOWN
Last Update Posted:
2019-01-15
First Post:
2019-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Course Radiation Therapy in Palliative Treatment of Esophageal Cancer
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 98}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2023-11-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-14', 'studyFirstSubmitDate': '2019-01-11', 'studyFirstSubmitQcDate': '2019-01-14', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of palliation using the short course scheme compared with the standard scheme: Likert scale', 'timeFrame': '3 months', 'description': 'reduction of initial symptoms after radiotherapy, assessed with Likert scale (dysphagia, odynophagia, regurgitation, chest-back pain are evaluated as none-mild-moderate-severe)'}], 'secondaryOutcomes': [{'measure': 'acute toxicity in the two treatment groups', 'timeFrame': '3 months', 'description': 'incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria'}, {'measure': 'late toxicity in the two treatment groups', 'timeFrame': '12 months', 'description': 'incidence of treatment-related adverse events in the two arms of the study registered using RTOG/EORTC Late Radiation Morbility Scoring Schema'}, {'measure': 'Quality of Life (QoL): EORTC questionnaire C15-PAL', 'timeFrame': '12 months', 'description': 'changes in QoL after the treatment assessed using European Organization for Research and Treatment of Cancer (EORTC) questionnaire C15-PAL (a specific questionnaire from EORTC developed to assess the quality of life of palliative cancer care patients)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Short Course Radiotherapy', 'Symptomatic esophageal lesions'], 'conditions': ['Esophageal Cancer', 'Radiotherapy', 'Palliative Care']}, 'descriptionModule': {'briefSummary': 'Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic esophageal malignant lesions', 'detailedDescription': 'Standard treatment for esophageal lesions (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic esophageal malignant lesions (primary solid tumors or metastases from solid tumor);\n* age\\>18 years;\n* ECOG performance status 0-3\n* no changes in supportive care in the week before radiotherapy\n\nExclusion Criteria:\n\n* pregnancy\n* previous irradiation of the same region'}, 'identificationModule': {'nctId': 'NCT03804203', 'briefTitle': 'Short Course Radiation Therapy in Palliative Treatment of Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Esophageal Cancer: an Interventional, Randomized, Multicentric Study', 'orgStudyIdInfo': {'id': 'RT 15-07 SHARON ESOPHAGUS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard treatment', 'description': 'patients in this group are treated with 3000 cGy in 10 daily fraction', 'interventionNames': ['Radiation: standard treatment']}, {'type': 'EXPERIMENTAL', 'label': 'short course treatment', 'description': 'patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)', 'interventionNames': ['Radiation: short course treatment']}], 'interventions': [{'name': 'standard treatment', 'type': 'RADIATION', 'description': '3000 cGy in 10 daily fractions', 'armGroupLabels': ['standard treatment']}, {'name': 'short course treatment', 'type': 'RADIATION', 'description': '2000 cGy in 4 fractions administered twice a day', 'armGroupLabels': ['short course treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'BO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessio G Morganti, MD', 'role': 'CONTACT', 'email': 'alessio.morganti2@unibo.it', 'phone': '0512143564', 'phoneExt': '+39'}], 'facility': 'Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Alessio G Morganti, MD', 'role': 'CONTACT', 'email': 'alessio.morganti2@unibo.it', 'phone': '0512143564', 'phoneExt': '+39'}], 'overallOfficials': [{'name': 'Alessio G Morganti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Alessio Giuseppe Morganti', 'investigatorAffiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}}}}