Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT04519905
Status:
RECRUITING
Last Update Posted:
2021-11-02
First Post:
2020-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], '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': 'D004938', 'term': 'Esophageal Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D011878', 'term': 'Radiotherapy'}], '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'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-31', 'studyFirstSubmitDate': '2020-08-12', 'studyFirstSubmitQcDate': '2020-08-19', 'lastUpdatePostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival difference of definitive radiotherapy and chemoradiotherapy groups', 'timeFrame': '3-year', 'description': 'The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.'}], 'secondaryOutcomes': [{'measure': 'difference of quality of life between different groups', 'timeFrame': 'the period of treatment within 7 weeks and follow up time with an average of 3months', 'description': 'Assess the quality of life through life quality questionnaire.'}, {'measure': 'radiation side effects', 'timeFrame': 'acute side effects within 3 months, late side effects for 3 months later', 'description': 'Record the radiation side effects including acute and late side effects.'}, {'measure': 'cancer specific survival', 'timeFrame': '3-year', 'description': 'The time between the start of the study treatment (Day 1) and death from tumor or last follow-up for patients alive at the end of the study.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['esophageal squamous cell carcinoma', 'elderly patients', 'chemoradiotherapy', 'definitive radiotherapy', 'survival'], 'conditions': ['Esophageal Squamous Cell Carcinoma', 'Chemoradiotherapy', 'Survival']}, 'descriptionModule': {'briefSummary': 'So far, there is no specific clinical guideline for elderly patients (\\>75 yr) with esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC were enrolled and randomly assigned to either definitive radiotherapy group (61.2Gy/34Fx） or the chemoradiotherapy group (50.4Gy/28Fx；Paclitaxel plus carboplatin). The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival.', 'detailedDescription': 'Up to now, definitive radiotherapy was major treatment plan for elderly ESCC patients. However, whether elective elderly patients can obtain survival benefits through chemoradiotherapy is not clear. Thus we design the clinical trail to answer the question.\n\nThree hundred and twenty elderly patients with ESCC would be recruited. There are two stratification factors including 80 years old and lymph node metastasis. The patients in the chemoradiotherapy group were treated with paclitaxel (45mg/m2) and carboplatin (AUC=2) one cycle per week for five cycles.The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival. The life quality questionnaire included QlQ-C30 and OES-18.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '76 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indicates no limit on eligibility based on the sex of participants\n* The 76 years old for the minimum age a potential participant must meet to be eligible for the clinical study.\n* Esophageal squamous cell carcinoma confirmed by pathology\n* No radiotherapy, chemotherapy or other treatments prior to enrollment\n* Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, TxNxM1b (M1b only for supraclavicular lymph node metastasis) (AJCC 6th)\n* Use of an effective contraceptive for adults to prevent pregnancy\n* No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function\n* No immunodeficiency\n* ECOG 0-1.\n* Life expectancy of more than 3 months.\n\nExclusion Criteria:\n\n* Total radiotherapy dose cannot reach 61.2Gy/34Fx\n* Esophageal perforation, or hematemesis\n* History of radiotherapy or chemotherapy for esophageal cancer\n* History of surgery within 28 days before Day 1\n* History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years)\n* Participation in other interventional clinical trials within 30 days\n* Pregnant or breast-feeding women or fertile patients\n* Drug addiction,\n* alcoholism or AIDS\n* Uncontrolled seizures or psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT04519905', 'briefTitle': 'Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)', 'orgStudyIdInfo': {'id': 'ESO-Shanghai15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'chemoradiotherapy', 'description': '50.4Gy/28Fx; Paclitaxel plus carboplatin', 'interventionNames': ['Drug: Paclitaxel plus carboplatin', 'Radiation: radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'radiotherapy', 'description': '61.2Gy/34Fx', 'interventionNames': ['Radiation: radiotherapy']}], 'interventions': [{'name': 'Paclitaxel plus carboplatin', 'type': 'DRUG', 'description': 'Paclitaxel （45mg/m2) plus carboplatin (AUC=2); five cycles; qw', 'armGroupLabels': ['chemoradiotherapy']}, {'name': 'radiotherapy', 'type': 'RADIATION', 'description': 'Different radiotherapy dose in different groups.', 'armGroupLabels': ['chemoradiotherapy', 'radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinjun C Ye, M.D.', 'role': 'CONTACT', 'email': 'jjye2004@163.com', 'phone': '13585175433', 'phoneExt': '13585175433'}, {'name': 'Jinjun C Ye, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jiangsu Cancer Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangpeng Zheng, M.D.', 'role': 'CONTACT', 'email': 'zhengxp@fudan.edu.cn', 'phone': '8621-62483180', 'phoneExt': '862162483180'}, {'name': 'Xiangpeng Zheng', 'role': 'CONTACT', 'email': 'zhengxp@fudan.edu.cn', 'phone': '862162483180', 'phoneExt': '862162483180'}, {'name': 'Xiangpeng Zheng', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Huadong Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kuaile Zhao, MD', 'role': 'CONTACT', 'email': 'kuaile_z@sina.com', 'phone': '18017312534'}], 'facility': 'Fudan Universtiy Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Kuaile Zhao, doctor', 'role': 'CONTACT', 'email': 'kuaile_z@sina.com', 'phone': '18017312534', 'phoneExt': '021-64175590'}, {'name': 'ying jia Deng, doctor', 'role': 'CONTACT', 'email': 'dengjiaying3@sina.com', 'phone': '18017312829'}], 'overallOfficials': [{'name': 'Kuaile Zhao, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Fudan University'}, {'name': 'Xiangpeng Zheng, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huadong Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Huadong Hospital', 'class': 'OTHER'}, {'name': 'Jiangsu Cancer Institute & Hospital', 'class': 'OTHER'}, {'name': 'Gansu Cancer Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, {'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}, {'name': 'Taihe Hospital', 'class': 'OTHER'}, {'name': "Wuxi No. 4 People's Hospital", 'class': 'OTHER'}, {'name': 'Ningbo No.2 Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}