Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT04699994
Status:
UNKNOWN
Last Update Posted:
2022-08-17
First Post:
2021-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Trial to Evaluate the Safety and Efficacy to Treat Esophageal Cancer Using 5-FU, Oxaliplatin, and Docetaxel
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-15', 'studyFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histological response rate (Grade 2 or 3 in Japanese Classification of Esophageal Cancer, 11th Edition)', 'timeFrame': '2.5 years'}], 'secondaryOutcomes': [{'measure': 'Response rate', 'timeFrame': '2.5 years'}, {'measure': 'Histological complete response rate', 'timeFrame': '2.5 years'}, {'measure': 'Treatment completion rate', 'timeFrame': '2.5 years'}, {'measure': 'Curative resection rate', 'timeFrame': '2.5 years'}, {'measure': 'Recurrence free survival', 'timeFrame': '4.5 years'}, {'measure': 'Overall survival', 'timeFrame': '4.5 years'}, {'measure': 'Incidence rate of adverse event during FLOT', 'timeFrame': '2.5 years'}, {'measure': 'Perioperative complication rate', 'timeFrame': '2.5 years'}, {'measure': 'Late phase complication rate', 'timeFrame': '4.5 years'}, {'measure': 'Incidence rate of severe adverse event', 'timeFrame': '2.5 years'}, {'measure': 'Incidence rate of all adverse event', 'timeFrame': '4.5 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The current multicenter prospective phase II study aims to evaluate the safety and efficacy of preoperative FLOT therapy for esophageal squamous cell carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically diagnosed as esophageal squamous cell carcinoma (squamous, adenosquamous, basaloid)\n2. Primary tumor is located mainly in the thoracic esophagus\n3. cT1N1-3M0-1 (only supraclavicular LN metastasis is included as M1), cT2-3N0-3M0-1 (only supraclavicular LN metastasis is included as M1)\n4. Twenty years old or older as of registration\n5. Performance status (PS) 0 or 1\n6. Patients have target lesions\n7. No previous history of esophageal cancer except for the followings\n\n1\\) pT1a-LPM (M2) or deeper following EMR/ESD 2) pT1a-MM (M3) with vascular invasion following EMR/ ESD 8. No previous history of chemotherapy/radiotherapy/endocrine therapy except for hormone therapy for prostate cancer after 5 years interval 9. Patients who meet the following criteria\n\n1. Neutrophil \\> 1,500 /mm3\n2. Platelet \\> 10.0x10\\^4 /mm3\n3. Hb ≧9.0 g/dL\n4. Total bilirubin ≦ 1.5 mg/dL\n5. AST ≦ 100 IU/L\n6. ALT ≦ 100 IU/L\n7. SpO2 ≧ 95 %\n8. Creatinine clearance ≧ 50 mL/min 10. Patients who can undergo esophagectomy 11. Agree with the participation to the current study\n\nExclusion Criteria:\n\n1. Patients who received any treatment for cancer within 3 years\n2. Patients who have active infectious diseases\n3. HBs Ag positive or HIV Ab positive\n4. Pregnant or breast feeding\n5. Patients with psychological disorder\n6. On systemic steroid therapy\n7. Require flucytocine, phenytoin, warfarin\n8. Allergic to iodine\n9. Allergic to DTX, LOHP, polisorbate 80\n10. Uncontrollable diabetes\n11. Severe COPD or lung fibrosis\n12. Severe hypertension\n13. Unstable angina\n14. Patients whom investigators evaluate as ineligible'}, 'identificationModule': {'nctId': 'NCT04699994', 'briefTitle': 'Prospective Trial to Evaluate the Safety and Efficacy to Treat Esophageal Cancer Using 5-FU, Oxaliplatin, and Docetaxel', 'organization': {'class': 'OTHER', 'fullName': 'Keio University'}, 'officialTitle': 'Multicenter Phase II Trial to Evaluate the Safety and Efficacy of FLOT Therapy for Resectable Esophageal Squamous Cell Carcinoma (Preoperative FLOT PII)', 'orgStudyIdInfo': {'id': 'N20190007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FLOT therapy', 'interventionNames': ['Drug: FLOT therapy']}], 'interventions': [{'name': 'FLOT therapy', 'type': 'DRUG', 'description': 'Preoperative FLOT therapy', 'armGroupLabels': ['FLOT therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1608582', 'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Satoru Matsuda', 'role': 'CONTACT', 'email': 's.matsuda.a8@keio.jp', 'phone': '+81333531211'}], 'facility': 'Keio University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'centralContacts': [{'name': 'Satoru Matsuda', 'role': 'CONTACT', 'email': 's.matsuda.a8@keio.jp', 'phone': '+81333531211'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keio University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Hirofumi Kawakubo', 'investigatorAffiliation': 'Keio University'}}}}