Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-04 @ 12:31 AM
Study NCT ID:
NCT03298204
Status:
COMPLETED
Last Update Posted:
2019-01-02
First Post:
2017-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Definitive (Chemo)Radiotherapy for Patients With Esophageal Cancer - 3JECROG R-01
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D011832', 'term': 'Radiation Injuries'}], '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': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2762}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-29', 'studyFirstSubmitDate': '2017-09-27', 'studyFirstSubmitQcDate': '2017-09-27', 'lastUpdatePostDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '1 year'}, {'measure': 'Overall survival', 'timeFrame': '2 year'}], 'secondaryOutcomes': [{'measure': 'Progress free survival', 'timeFrame': '1 year'}, {'measure': 'Progress free survival', 'timeFrame': '2 year'}, {'measure': 'Locoregional recurrence free survival', 'timeFrame': '1 year'}, {'measure': 'Locoregional recurrence free survival', 'timeFrame': '2 year'}, {'measure': 'Distant metastasis free survival', 'timeFrame': '1 year'}, {'measure': 'Distant metastasis free survival', 'timeFrame': '2 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophagus Cancer', 'Chemoradiation', 'Chemotherapy Effect', 'Radiotherapy Side Effect']}, 'descriptionModule': {'briefSummary': 'The aim of this observational study is to retrospectively collect survival data for 3000 primary esophageal cancer patients from multicenter between January 2000 to present. Based on a Cox model, we want to develope a nomogram that predicts local recurrence, distant metastases, and survival for patients treated with radiotherapy or chemoradiotherapy with or without chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with esophageal or esophagogastric junction cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed squamous cell carcinoma, adenocarcinoma of the esophageal or esophagogastric junction Unresectable or potentially resectable tumor (cT3-4N0-1M0-M1b, without visceral metastasis, according to AJCC 6th) based on standard primary staging by EUS and CT\n* Age\\>18 years\n* No distant metastasis other than supraclavicular lymph nodes\n* No prior history of thoracic radiation\n* Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits\n\nExclusion Criteria:\n\n* Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer during 5 years before diagnosis of esophageal cancer\n* Pregnant or lactating females\n* Contraindication for radiotherapy or chemotherapy'}, 'identificationModule': {'nctId': 'NCT03298204', 'briefTitle': 'Definitive (Chemo)Radiotherapy for Patients With Esophageal Cancer - 3JECROG R-01', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'A Multicenter Analysis of Definitive (Chemo)Radiotherapy With or Without Chemotherapy for Patients With Esophageal Cancer - 3JECROG-R01', 'orgStudyIdInfo': {'id': '3JECROG R-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chemoradiotherapy'}, {'label': 'Chemoradiotherapy following chemotherapy'}, {'label': 'Chemoradiotherapy followed by chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'country': 'China', 'facility': 'Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hebei Medical University Fourth Hospital', 'class': 'OTHER'}, {'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}, {'name': 'Anyang Tumor Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Hebei University', 'class': 'OTHER'}, {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, {'name': 'Beijing Hospital', 'class': 'OTHER_GOV'}, {'name': "Tengzhou Central People's Hospital", 'class': 'OTHER_GOV'}, {'name': 'PLA Army General Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Zefen Xiao', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}