Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-01-01 @ 8:42 PM
Study NCT ID:
NCT03990532
Status:
UNKNOWN
Last Update Posted:
2022-09-23
First Post:
2019-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simultaneous Integrated Boost for Mediastinal Lymph Node Recurrence After Radical Surgery 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017322', 'term': 'Clinical Trials, Phase II as Topic'}], 'ancestors': [{'id': 'D002986', 'term': 'Clinical Trials as Topic'}, {'id': 'D000068456', 'term': 'Clinical Studies as Topic'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-21', 'studyFirstSubmitDate': '2019-06-16', 'studyFirstSubmitQcDate': '2019-06-17', 'lastUpdatePostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose limiting toxicity(DLT) of Simulatianeous Integrated Boost (SIB)', 'timeFrame': 'up to 3 months', 'description': 'DLT was defined as grade 4 or higher hematological toxicities and/or grade 3 or higher nonhematological toxicities.'}, {'measure': 'Overall survival (phase II)', 'timeFrame': 'up to 1 year', 'description': 'Survival time was measured from the date of study enrollment to the date of death or last follow-up;'}], 'secondaryOutcomes': [{'measure': 'Overall survival (phase I)', 'timeFrame': 'up to 1 year', 'description': 'Survival time was measured from the date of study enrollment to the date of death or last follow-up;'}, {'measure': 'Late toxicity (phase I)', 'timeFrame': 'up to 2 year', 'description': 'late toxicity were grade according to RTOG and CTCAE criteria'}, {'measure': 'Overall survival (phase II)', 'timeFrame': 'up to 2 year', 'description': 'Survival time was measured from the date of study enrollment to the date of death or last follow-up;'}, {'measure': 'acute Toxicity (phase II)', 'timeFrame': 'up to 3 months', 'description': 'acute toxicity were grade according to CTCAE criteria'}, {'measure': 'late Toxicity (phase II)', 'timeFrame': 'up to 2 year', 'description': 'late toxicity were grade according to RTOG and CTCAE criteria'}, {'measure': '1-year local progression-free survival', 'timeFrame': 'up to 1 year', 'description': 'From treatment initiation to first documented local progression or death or censor'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Cancer', 'Salvage Radiotherapy', 'Dose-escalation', 'Mediastinal Lymph Node Recurrence']}, 'descriptionModule': {'briefSummary': 'Esophageal cancer (EC) ranks the seventh most diagnosed malignant tumor (572,000 new cases) and the sixth cancer-related mortality (509,000 deaths) worldwide in 2018. The incidence of EC is strikingly varying among the regions and sexes. Approximately 70% of EC cases occur in men, and there is a 2-fold to 3-fold difference in incidence and mortality rates between regions worldwide. According to the latest reported in 2017, esophageal cancer ranks the sixth most common cancer and the fourth leading cause of cancer-mortality in China. Currently, esophagectomy is considered as the standard treatment for resectable EC patients. However, the prognosis of stage IIA-III esophageal cancer after esophagectomy remains poor, and local regional lymph node recurrence is the major patterns of recurrence, and mediastinal lymph node recurrence is one of the most common sites. Previous retrospective study has found that salvage chemoradiotherapy is a effective treatment option for these patients. However, the optimal dose remains unknown. In addition, no prospective trials have been conducted to investigate the efficacy and toxicities of salvage chemo-radiotherapy by using simultaneous integrated boost for the treatment of mediastinal lymph node recurrence after radical surgery of esophageal Cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHisto-pathologically proven diagnosis of esophageal squamous cell carcinoma. Age ≥18 and ≤80 ECOG performance status 0-1. Clinical diagnosis of ≤5 mediastinal lymph nodes recurrence after esophagectomy.\n\nPatients without distant metastasis and life expectancy ≥ 3 months. adequate liver and renal function and adequate bone marrow reservation. Written, signed informed consent.\n\nExclusion Criteria:\n\nPrior radiotherapy to recurrence site of esophageal cancer. Other co-existing malignancies or malignancies diagnosed within the last 5 years.\n\nPregnant women. Women who are breastfeeding a baby. Patients with uncontrolled serious medical or mental illnesses.'}, 'identificationModule': {'nctId': 'NCT03990532', 'briefTitle': 'Simultaneous Integrated Boost for Mediastinal Lymph Node Recurrence After Radical Surgery of Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Phase I/II Dose Escalation by Simultaneous Integrated Boost for Mediastinal Lymph Node Recurrence After Radical Surgery of Esophageal Cancer', 'orgStudyIdInfo': {'id': 'RJH2019-69'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment group', 'interventionNames': ['Radiation: treatment group(phase I)', 'Radiation: treatment group (phase II)']}], 'interventions': [{'name': 'treatment group(phase I)', 'type': 'RADIATION', 'description': 'Dose-escalation plan (phase I)\n\nRadiotherapy:\n\nLEVEL 1: dose given at PTV-G will be 58.8Gy/28 fractions； 2.1Gy/per fraction; LEVEL 2: dose given at PTV-G will be 64.4Gy/28 fractions； 2.3Gy/per fraction; LEVEL 3: dose given at PTV-G will be 70Gy/28 fractions； 2.5Gy/per fraction Concurrent chemotherapy: 5-Fu/capecitabine/S-1+DDP or S-1 or Capecitabine', 'armGroupLabels': ['treatment group']}, {'name': 'treatment group (phase II)', 'type': 'RADIATION', 'description': 'Radiotherapy dose was prescribed according to phase I trial results; Concurrent chemotherapy: 5-Fu/capecitabine/S-1+DDP or S-1 or Capecitabine', 'armGroupLabels': ['treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei-Xiang Qi', 'role': 'CONTACT', 'email': 'qiweixiang1113@163.com', 'phone': '+86-021-13761059660'}], 'facility': 'Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Wei-Xiang Qi, Dr.', 'role': 'CONTACT', 'email': 'qiweixiang1113@163.com', 'phone': '+86-021-64370045'}, {'name': 'shengguang zhao, Dr.', 'role': 'CONTACT', 'email': 'zhaoshengguang@163.com', 'phone': '+86-021-64370045'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate chief physician', 'investigatorFullName': 'Shengguang Zhao', 'investigatorAffiliation': 'Ruijin Hospital'}}}}