Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
Study NCT ID:
NCT05569668
Status:
COMPLETED
Last Update Posted:
2022-10-06
First Post:
2022-10-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemotherapy Compared With Surgery for Esophageal Carcinoma
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': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D017671', 'term': 'Platinum Compounds'}], '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': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 826}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-05', 'studyFirstSubmitDate': '2022-10-02', 'studyFirstSubmitQcDate': '2022-10-05', 'lastUpdatePostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OS(overall survival)', 'timeFrame': 'From date of patient admission to the inpatient thoracic surgery department until the date of first documented death from any cause, assessed up to 100 months', 'description': 'OS was defined as the first date of patient admission to the inpatient thoracic surgery department to the date of death from any cause.'}], 'secondaryOutcomes': [{'measure': 'DFS(disease-free survival)', 'timeFrame': 'From date of patient admission to the inpatient thoracic surgery department until the date of first documented progression, assessed up to 100 months', 'description': 'DFS was defined as the first day of patients admission to the inpatient department to the date of tumor recurrence confirmed by the follow-up tests.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophagus Cancer']}, 'descriptionModule': {'briefSummary': 'Most ESCC received NAC in China without supportive evidence from local RCTs. The negative conclusion about NAC originated from Western countries in the 1990s. Whether two-field extensive mediastinal lymphadenectomy and paclitaxel/platinum-based chemotherapy results in better survival should be determined. As the highest ESCC incidence area worldwid, we tried to analyze this top with big data by using a single-center case-control retrospective PMS study. Paclitaxel- and platinum-based NAC combined with two-field of the extensive mediastinal lymphadenectomy might provide better survival benefits than primary esophagectomy for stage II/III SCC.', 'detailedDescription': "Treatment Neoadjuvant Chemotherapy Standard NAC comprised 2 cycles. Platinum plus paclitaxel or docetaxel was repeated once every 3 weeks. Cis-platinum was administered at a total dose of 75 mg/m2 by continuous infusion on d1 or equal divided on Days 2-4 or Days 1-3. Paclitaxel, 175 mg/m2, d1, or paclitaxel, 87.5 mg/m2, d1, d8. If the docetaxel was adopted, it was given as 75 mg/m2 on Day 1.\n\nSurgical Procedure At approximately 6-8 weeks after NAC, open (McKeown, left thoracic incision left cervical anastomosis) or MIE via thoracoscopy and/or laparoscopy was performed in the patients. Bilateral laryngeal recurrent nerve lymph node dissection was requested for every patient.\n\nComparisons between the NAC and primary surgery groups were performed using the chi-square test, Mann-Whitney U test and Fisher's exact test for categorical parameters after PMS. Kaplan-Meier curves and a Cox proportional hazards regression model were adopted to perform OS analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Clinical diagnosis of Esophageal Squamous Cell Carcinoma(ESCC) at Henan Cancer Hospital between January 1, 2015, and December 31, 2018', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Esophageal Squamous Cell Carcinoma(ESCC) at Henan Cancer Hospital between January 1, 2015, and December 31, 2018 and the data was prospectively collected in the hubble of the LinkDoc data company\n* Surgery performed in the thoracic surgery department\n* No previous cancer treatment\n\nExclusion Criteria:\n\n* Patients with secondary cancer were excluded'}, 'identificationModule': {'nctId': 'NCT05569668', 'briefTitle': 'Neoadjuvant Chemotherapy Compared With Surgery for Esophageal Carcinoma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'Neoadjuvant Chemotherapy Compared With Surgery for Esophageal Carcinoma: A Missing Evidence and A Retrospective Case-control Study', 'orgStudyIdInfo': {'id': 'HCH2101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neoadjuvant chemotherapy group', 'description': 'Standard NAC comprised 2 cycles. Platinum plus paclitaxel or docetaxel was repeated once every 3 weeks. Cis-platinum was administered at a total dose of 75 mg/m2 by continuous infusion on d1 or equal divided on Days 2-4 or Days 1-3. Paclitaxel, 175 mg/m2, d1, or paclitaxel, 87.5 mg/m2, d1, d8. If the docetaxel was adopted, it was given as 75 mg/m2 on Day 1. Then surgery----esophagectomy and two-field extensive mediastinal lymphadenectomy. After surgery, there might be a adjuvant chemotherayp for pathologically positive lymph nodes patients.'}, {'label': 'Primary surgery group', 'description': 'The patients would receive primary surgery----esophagectomy and two-field extensive mediastinal lymphadenectomy. After surgery, there might be a adjuvant chemotherayp for pathologically positive lymph nodes patients. .', 'interventionNames': ['Drug: Paclitaxel- and platinum-based chemotherapy']}], 'interventions': [{'name': 'Paclitaxel- and platinum-based chemotherapy', 'type': 'DRUG', 'description': 'Neoadjuvant Chemotherapy', 'armGroupLabels': ['Primary surgery group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'overallOfficials': [{'name': 'Yan Zheng, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}