Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-03-03 @ 3:53 PM
Study NCT ID:
NCT01963702
Status:
UNKNOWN
Last Update Posted:
2013-10-16
First Post:
2013-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Trial of Exploring the Predictive Factors of TX and XELOX Regimen in the First Line Treatment of MGC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}], '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': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-12', 'studyFirstSubmitDate': '2013-10-09', 'studyFirstSubmitQcDate': '2013-10-12', 'lastUpdatePostDateStruct': {'date': '2013-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'overall survival(OS)', 'timeFrame': 'from the date of randomization until the date of death from any cause, assessed up to 60 months', 'description': 'OS is defined as from the date of randomization until the date of death from any cause, assessed up to 60 months'}], 'primaryOutcomes': [{'measure': 'objective response', 'timeFrame': '6 weeks', 'description': 'RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) will be used to evaluate the response of each patient every 6 weeks. The main purpose of this study is to search for the biomarkers which will predict the response of patients with MGC received TX or XELOX regimen as first line therapy'}], 'secondaryOutcomes': [{'measure': 'progression free survival (PFS)', 'timeFrame': 'From randomization until first documented progression or date of death from any cause, whichever came first (up to 60 months)', 'description': 'PFS is defined as from the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['predictive factor', 'response', 'gastric neoplasm', 'oxaliplatin', 'docetaxol', 'capecitabine'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': "Platinum, fluorouracil and taxane based regimen are all acceptable in the first line treatment of metastatic gastric cancer. The TX and XELOX regimen are two common regimen used in MGC. whichever regimen is used, the average response rate is less than 50%. So a rather part of patients can't get benefit from the treatment. It is urgent to find out the predictive factors of these regimens in order to get a higher response and better survival outcome.", 'detailedDescription': 'Patients with MGC will be treated with TX or XELOX regimen. Before treatment, 14 days after treatment and after progression, the blood sample will be collected. Primary tumor blocks will also of collected. These samples will be used to detect predictive factors of the two types first line therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chemo-naive patients with metastatic, unresectable, histologically confirmed gastric or Gastroesophageal adenocarcinoma; Patients who received adjuvant chemotherapy, the duration from the last therapy to relapse at least longer than 6 months\n* Patient must have at least one measurable lesions (RECIST 1.1)\n* 18 Years to 75 years\n* Written informed consent obtained\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Patients must have adequate organ and marrow function as defined below:\n* neutrophilicgranulocyte greater than/equal to 1,500/mm3;\n* platelets greater than/equal to 90,000/ mm3;\n* hemoglobin greater than/equal to 9 gm/dL (may be transfused to maintain or exceed this level);\n* total bilirubin less than/equal to 1.5 within institutional upper limit of normal (IULN);\n* Aspartate Transaminase (AST,SGOT)/Alanine transaminase (ALT,SGPT) less than/equal to 2.5 times IULN\n* serum creatinine less than/equal to 1.5 x IULN.\n\nExclusion Criteria:\n\n* Active clinically serious infections (\\> grade 2 NCI-CTC version 3.0, National Cancer Institute-Common Terminology Criteria for Adverse Events)\n* Symptomatic metastatic brain or meningeal tumors\n* History of organ allograft\n* Patients undergoing renal dialysis\n* chronic inflammatory bowel disease; ileus; genetic fructose intolerance\n* Patients who received adjuvant chemotherapy and the duration from the last therapy less than 6 months\n* Receive previously radiotherapy in measurable regions\n* Pregnancy or lactating status\n* Concurrent malignancy other than nonmelanoma skin cancer, or in situ cervix carcinoma\n* Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months\n* Acute or subacute intestinal occlusion or history of the inflammatory bowel disease\n* Any factors that influence the usage of oral administration'}, 'identificationModule': {'nctId': 'NCT01963702', 'briefTitle': 'A Phase II Trial of Exploring the Predictive Factors of TX and XELOX Regimen in the First Line Treatment of MGC', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Phase II Trial of Exploring the Predictive Factors of Docetaxol Plus Capecitabine(TX) Regimen and Oxaliplatin Plus Capecitabine (XELOX) Regimen in the First Line Treatment of Patients With Metastatic Gastric Cancer (MGC)', 'orgStudyIdInfo': {'id': 'FDZL-TXELOX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Docetaxol ＆Capecitabine (TX)', 'description': 'Docetaxol: 75 mg/m2 d1, (From MAY 15th 2013, the dose was reduced to 60mg/m2 for high incidence of G3/4 myelosuppression after approved by institute Ethics Committee) ; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles', 'interventionNames': ['Drug: Docetaxol', 'Drug: Capecitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxaliplatin ＆Capecitabine (XELOX)', 'description': 'Oxaliplatin: 130 mg/m2 d1; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles', 'interventionNames': ['Drug: Oxaliplatin', 'Drug: Capecitabine']}], 'interventions': [{'name': 'Docetaxol', 'type': 'DRUG', 'armGroupLabels': ['Docetaxol ＆Capecitabine (TX)']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'armGroupLabels': ['Oxaliplatin ＆Capecitabine (XELOX)']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['xeloda'], 'armGroupLabels': ['Docetaxol ＆Capecitabine (TX)', 'Oxaliplatin ＆Capecitabine (XELOX)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xiaodong Zhu, M.D', 'role': 'CONTACT', 'email': 'xddr001@163.com', 'phone': '+862164175590', 'phoneExt': '5000'}, {'name': 'xiaodong Zhu, M.D', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fudan University Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'xiaodong Zhu, M.D', 'role': 'CONTACT', 'email': 'xddr001@163.com', 'phone': '+862164175590', 'phoneExt': '5000'}], 'overallOfficials': [{'name': 'Jin Li, M.D / Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Xiaodong Zhu', 'investigatorAffiliation': 'Fudan University'}}}}