Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-06-10 @ 3:26 PM
Study NCT ID:
NCT03328234
Status:
UNKNOWN
Last Update Posted:
2019-01-02
First Post:
2017-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiotherapy With or Without Concurrent Chemotherapy for Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-03
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-29', 'studyFirstSubmitDate': '2017-10-28', 'studyFirstSubmitQcDate': '2017-10-28', 'lastUpdatePostDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '1 year'}, {'measure': 'Overall survival (OS)', 'timeFrame': '2 year'}, {'measure': 'Overall survival (OS)', 'timeFrame': '3 year'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': '1 year'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': '2 year'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': '3 year'}, {'measure': 'Local recurrence-free rate（LRFS）', 'timeFrame': '1 year'}, {'measure': 'Local recurrence-free rate（LRFS）', 'timeFrame': '2 year'}, {'measure': 'Local recurrence-free rate（LRFS）', 'timeFrame': '3 year'}, {'measure': 'Completion Rate', 'timeFrame': 'up to 2 year'}, {'measure': 'Adverse events', 'timeFrame': 'up to 5 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators aimed to compare elective nodal irradiation versus involved field irradiation with or without concurrent chemotherapy and the addition of consolidation chemotherapy for patients with extensive lymphatic metastasis of esophageal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\<70\n* Diagnosis of clinical stage T2-4N0-1M1（According to UICC 2002）\n* A untreated squamous esophageal carcinoma\n* Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3\n* Adequate organ function\n* No known history of drug allergy\n* Blood routine examination : WBC≥4.0\n* hepatic and renal function are normal\n\nExclusion Criteria:\n\n* Age≥ 70 or ≤ 16\n* Already received the treatment of chemotherapy or radiotherapy\n* Pregnant or lactating females\n* Known drug allergy\n* Without agreement of informed consent form\n* Insufficient hepatorenal function or Blood routine examination\n* Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.'}, 'identificationModule': {'nctId': 'NCT03328234', 'briefTitle': 'Radiotherapy With or Without Concurrent Chemotherapy for Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-03', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'A Randomized Phase III Study of Simultaneous Integrated Boost Intensity Modulated Radiation Therapy (SIB-IMRT) With or Without Concurrent Chemotherapy Followed by Consolidation Chemotherapy for Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P03', 'orgStudyIdInfo': {'id': '3JECROG P-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SIB-IMRT combined chemotherapy with IFI', 'interventionNames': ['Radiation: SIB-IMRT', 'Drug: Paclitaxel', 'Drug: Platinum-Based Drug', 'Other: Involved Field Irradiation (IFI)']}, {'type': 'EXPERIMENTAL', 'label': 'SIB-IMRT with IFI', 'interventionNames': ['Radiation: SIB-IMRT', 'Drug: Paclitaxel', 'Drug: Platinum-Based Drug', 'Other: Involved Field Irradiation (IFI)']}], 'interventions': [{'name': 'SIB-IMRT', 'type': 'RADIATION', 'description': 'Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.', 'armGroupLabels': ['SIB-IMRT combined chemotherapy with IFI', 'SIB-IMRT with IFI']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': '45-50mg/m2, once a week, concurrent with radiotherapy for 5-6weeks', 'armGroupLabels': ['SIB-IMRT combined chemotherapy with IFI']}, {'name': 'Platinum-Based Drug', 'type': 'DRUG', 'description': 'Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks', 'armGroupLabels': ['SIB-IMRT combined chemotherapy with IFI']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': '135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy', 'armGroupLabels': ['SIB-IMRT combined chemotherapy with IFI', 'SIB-IMRT with IFI']}, {'name': 'Platinum-Based Drug', 'type': 'DRUG', 'description': 'Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy', 'armGroupLabels': ['SIB-IMRT combined chemotherapy with IFI', 'SIB-IMRT with IFI']}, {'name': 'Involved Field Irradiation (IFI)', 'type': 'OTHER', 'description': 'CTV was defined as GTV with a 3.0-5.0 cm craniocaudal margin and a 0.6-0.8 cm lateral margin and GTVnd with a 0.5-1.0 cm margin.', 'armGroupLabels': ['SIB-IMRT combined chemotherapy with IFI', 'SIB-IMRT with IFI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Wang, MD', 'role': 'CONTACT', 'email': 'beryl_wx2000@163.com', 'phone': '+861013311583220'}], '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}}], 'centralContacts': [{'name': 'Xin Wang, MD', 'role': 'CONTACT', 'email': 'beryl_wx2000@163.com', 'phone': '+86-13311583220'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pricipal investigator', 'investigatorFullName': 'Zefen Xiao', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}