Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-28 @ 11:54 AM
Study NCT ID:
NCT00915850
Status:
UNKNOWN
Last Update Posted:
2010-09-09
First Post:
2009-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-09-08', 'studyFirstSubmitDate': '2009-06-05', 'studyFirstSubmitQcDate': '2009-06-05', 'lastUpdatePostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST)', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'To determine the recommended phase II dose of docetaxel (Phase I)', 'timeFrame': '1 month'}, {'measure': 'To determine the clinical effectiveness in the patients with measurable disease (Phase I)', 'timeFrame': '1 month'}, {'measure': 'To analyze the toxicity (Phase II)', 'timeFrame': '1 month'}, {'measure': 'Time to progression (Phase II)', 'timeFrame': '5 years'}, {'measure': 'median survival time (Phase II)', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'This phase I/II study is being conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (DCF) in unresectable advanced esophageal cancer. The usefulness of the this regimen is evaluated by RECIST, time to progression and median survival time.', 'detailedDescription': '\\<Phase I\\>\n\nPrimary Objective:\n\nTo establish the safety of combination chemotherapy comprising docetaxel (escalating doses: 25,30,35,40 mg/m2,day1 and day8), cisplatin (12mg/m2,day1-5), and fluorouracil (600mg/m2,day1-5) (DCF) in unresectable advanced esophageal cancer.\n\nSecondary Objective:\n\nTo observe the efficacy of this regimen in these patients.\n\n\\<Phase II\\>\n\nPrimary Objective:\n\nTo assess the response rate of combination chemotherapy comprising docetaxel (recommended dose determined in phase I study,day1 and day8), cisplatin (12 mg/m2, day1-5), and fluorouracil (600 mg/m2, day1-5) (DCF) in unresectable advanced esophageal cancer.\n\nSecondary Objectives:\n\nTo determine the adverse reactions of this regimen in these patients. To determine TTP(Time to progression) of patients treated with this regimen. To determine MST(Median survival time) of patients treated with this regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer measurable disease by CT scan\n* ECOG performance status 0-1\n* 20 years and older\n* Patients must have clinically documented unresectable or metastatic esophageal cancer and histologic confirmation of the diagnosis with tumor\n* Tissue from tumor must be available\n* Patients must have measurable disease\n* Patients may have received prior adjuvant chemotherapy; this must have been completed at least 1 month\n* Life expectancy \\> 3 months\n* Laboratory values as follows\n* 3000/mm3 \\< WBC \\< 12000/mm3\n* 1500/mm3 \\< granulocyte count\n* 8.0 gm/dl \\< hemoglobin\n* Platelet count \\> 100000/mm3\n* Aspartate transaminase \\< 150 IU/L\n* Alanine transaminase \\< 150 IU/L\n* Creatinine \\< 1.5 mg/dl\n* Able and willing to give valid written informed consent\n\nExclusion Criteria:\n\n* Pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception)\n* Active or uncontrolled infection\n* Prior chemotherapy or radiation therapy within 4 weeks, surgery within 3 weeks or immunotherapy within 1 week\n* Clinically significant heart disease\n* Patients with a history of myocardial infarction within the previous three months\n* Patients with uncontrolled diabetes mellitus or hypertension\n* Presence of clinically apparent central nervous system metastases\n* Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study\n* Decision of unsuitableness by principal investigator or physician-in-charge'}, 'identificationModule': {'nctId': 'NCT00915850', 'briefTitle': 'Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)', 'organization': {'class': 'OTHER', 'fullName': 'Wakayama Medical University'}, 'officialTitle': 'Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.', 'orgStudyIdInfo': {'id': 'WMU-EC01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anticancer drug', 'description': 'docetaxel, cisplatin and 5-FU', 'interventionNames': ['Drug: DCF']}], 'interventions': [{'name': 'DCF', 'type': 'DRUG', 'otherNames': ['docetaxel+Cisplatin+5-FU'], 'description': 'docetaxel, Cisplatin and 5-FU', 'armGroupLabels': ['Anticancer drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '641-8510', 'city': 'Wakayama', 'state': 'Wakayama', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Makoto Iwahashi, MD', 'role': 'CONTACT', 'email': 'makato@wakayama-med.ac.jp', 'phone': '81-73-441-0613'}], 'facility': 'Wakayama Medical University', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}], 'centralContacts': [{'name': 'Makoto Iwahashi, MD', 'role': 'CONTACT', 'email': 'makoto@wakayama-med.ac.jp', 'phone': '81-73-441-0613'}], 'overallOfficials': [{'name': 'Makoto Iwahashi, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Second Department of Surgery, Wakayama Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wakayama Medical University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Makoto Iwahasi', 'oldOrganization': 'Wakayama Medical University'}}}}