Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-01-15 @ 3:03 AM
Study NCT ID:
NCT01836120
Status:
UNKNOWN
Last Update Posted:
2013-04-19
First Post:
2013-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer
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': 'C068874', 'term': 'raltitrexed'}, {'id': 'D000077143', 'term': 'Docetaxel'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-18', 'studyFirstSubmitDate': '2013-04-17', 'studyFirstSubmitQcDate': '2013-04-18', 'lastUpdatePostDateStruct': {'date': '2013-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': '1 years'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': '1 year'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['second-line chemotherapy', 'Raltitrexed'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'A study of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with Gastric Cancer.The purpose of this study is to compare the activity of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with gastric carcinoma by estimating progression free survival (PFS) in each treatment arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent form\n2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;\n3. Histologically or cytologically confirmed gastric cancer;\n4. The first-line chemotherapy failure (required containing 5-fluorouracil)\n5. At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )\n6. Life expectancy of at least 3 months;\n\nExclusion Criteria:\n\n1. Received any prior treatment including Raltitrexed;\n2. Active or uncontrolled infection;\n3. Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;\n4. Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT01836120', 'briefTitle': 'A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Tumor Hospital'}, 'officialTitle': 'A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer', 'orgStudyIdInfo': {'id': 'HBTH103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Raltitrexed plus Docetaxel', 'interventionNames': ['Drug: Raltitrexed plus Docetaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Docetaxel', 'interventionNames': ['Drug: Docetaxel']}], 'interventions': [{'name': 'Raltitrexed plus Docetaxel', 'type': 'DRUG', 'description': 'Raltitrexed plus Docetaxel (Raltitrexed 3mg/m2 d\n\n1; Docetaxel 75mg/m2 d1, every 3 weeks, 4-6 cycles)', 'armGroupLabels': ['Raltitrexed plus Docetaxel']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'Docetaxel (Docetaxel 75mg/m2 d1, every 3weeks,4-6 cycles)', 'armGroupLabels': ['Docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050011', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Hebei Tumor Hospital', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Tumor Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}