Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-01-24 @ 7:11 PM
Study NCT ID:
NCT04115618
Status:
UNKNOWN
Last Update Posted:
2019-10-04
First Post:
2019-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SIB in Upper Thoracic Esophageal Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Using IMRT technology, two fields are irradiated synchronously, prescription radiation dose: 50.4 Gy/28F in PTV-C, 1.8 Gy per fraction; 63 Gy/28F in PTV-G, 2.25 Gy per fraction. Six times of concurrent DP week regimen chemotherapy: cisplatin 20mg/m2 qw plus docetaxel 20mg/m2 qw.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-02', 'studyFirstSubmitDate': '2019-09-29', 'studyFirstSubmitQcDate': '2019-10-02', 'lastUpdatePostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity Effect', 'timeFrame': '8 Weeks', 'description': 'Toxicity effect defined as over CTCAE 4 grade 3 acute radiation toxicity of esophagitis 2 weeks after completion of 6 weeks of radiation therapy.'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'One month', 'description': 'Time of disease progression or unrecorded time of death due to any cause from the day of admission to the first imaging confirmation'}, {'measure': 'OS', 'timeFrame': 'One month', 'description': 'Time from admission to death'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['esophageal cancer', 'Chemoradiotherapy', 'Simultaneous Integrated Boost Intensity'], 'conditions': ['Esophageal Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study was designed to predict the toxicity and efficacy of Simultaneous Integrated Boost Intensity-modulated Chemoradiotherapy in Upper Thoracic I-IVA Esophageal Squamous Cell Carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histological or cytologic diagnosis of esophageal squamous carcinoma;\n2. Aged 18-75 years;\n3. KPS ≥ 70;\n4. Upper thoracic esophageal squamous carcinoma: the upper margin of the lesion is located between the entrance of esophagus and the inferior edge of the azygos vein;\n5. Stage I-IVA(AJCC 6th,2009);\n6. Not able to be surgically resection or rejected;\n7. Not have received any prior anticancer therapy;\n8. No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥4x109/L, Neutrophils (ANC )≥1.5x10\\^9/L, platelet count ≥100x 10\\^9/L, serum creatinine\\<1.5 mg/dL,urea nitrogen \\<8 mmol/L;\n9. No history of malignancy;\n10. No perforation of esophagus, no deep ulcer of esophagus;\n11. Joined the study voluntarily and signed informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;\n2. Patient who has metastasis such as lung, liver metastasis;\n3. Other malignant tumors;\n4. Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;\n5. Uncontrollable heart disease, diabetes and hypertension, pulmonary fibrosis, and chest confirmed active pulmonary inflammation require antibiotic treatment, as well as superior vena cava compression syndrome;\n6. After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy;\n7. Combination of pure red cell anemia or gamma globulin;\n8. Allergic to any medication component studied.'}, 'identificationModule': {'nctId': 'NCT04115618', 'briefTitle': 'SIB in Upper Thoracic Esophageal Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Simultaneous Integrated Boost Intensity-modulated Chemoradiotherapy in Upper Thoracic Esophageal Squamous Cell Carcinoma: a Phase II Study of Single Institution', 'orgStudyIdInfo': {'id': '2017-ESCCSIB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SIB', 'description': 'Simultaneous integrated boost intensity-modulated chemoradiotherapy', 'interventionNames': ['Radiation: Simultaneous integrated boost intensity-modulated chemoradiotherapy']}], 'interventions': [{'name': 'Simultaneous integrated boost intensity-modulated chemoradiotherapy', 'type': 'RADIATION', 'description': 'Using IMRT technology, two fields are irradiated synchronously, prescription radiation dose: 50.4 Gy/28F in PTV-C, 1.8 Gy per fraction; 63 Gy/28F in PTV-G, 2.25 Gy per fraction. Six times of concurrent DP week regimen chemotherapy: cisplatin 20mg/m2 qw plus docetaxel 20mg/m2 qw.', 'armGroupLabels': ['SIB']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xi Yang, Phd', 'role': 'CONTACT', 'email': 'ntgeorge@qq.com', 'phone': '86-17321296901'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xi Yang, Phd', 'role': 'CONTACT', 'email': 'ntgeorge@qq.com', 'phone': '86-17321296901'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhengfei Zhu', 'investigatorAffiliation': 'Fudan University'}}}}