Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-28 @ 12:35 PM
Study NCT ID:
NCT01472250
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2011-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'the tumor tissue samples were collected to do gene mutation analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 498}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-07', 'studyFirstSubmitDate': '2011-10-28', 'studyFirstSubmitQcDate': '2011-11-11', 'lastUpdatePostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'chemotherapy regimen', 'timeFrame': '2 months', 'description': 'To evaluate the treatment model (singel or doublet or triplet chemotherapy)of patients with advanced gastric cancer in China'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '2 months', 'description': 'OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 2 months till death or lost'}, {'measure': 'quality of life', 'timeFrame': '6 weeks', 'description': 'To evaluate the quality of life before and after chemotherapy of Chinese patients in real clinical practice'}, {'measure': 'treatment expense', 'timeFrame': '2 months', 'description': 'To evaluate the treatment expense of first-line treatment of Chinese patients with advanced gastric cancer in real clinical practice'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced Gastric Cancer', 'chemotherapy', 'quality of life', 'treatment expense', 'patients accepted first-line chemotherapy'], 'conditions': ['Advanced Gastric Cancer']}, 'descriptionModule': {'briefSummary': "This is a multi-center, prospective and observational clinical study. Eligible patients will accept generalized chemotherapy according to the investigator's assessment. Information related to the treatment, including medication, disease condition, expenses, etc. will be periodically collected. Follow-up at 2-month intervals will be periodically performed to continually collect information about the disease progression, subsequent treatment and survival until death or completion of the study.\n\nRecruited patients will fill out questionnaires about quality of life before initiation of treatment, at Cycle 3 and completion of first-line treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with advanced gastric cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The patient has histologically confirmed locally-advanced or recurrent and/or metastatic gastric or esophagogastric junction adenocarcinoma, has missed the opportunity of surgical excision, making curative therapy impossible.\n2. The informed consent form is signed.\n3. A specimen of tumor tissue (puncture biopsy or surgical specimen) is available.\n4. ECOG performance status is 0, 1 or 2.\n5. The patient's general conditions and functions of important organs allow generalized chemotherapy according to the investigator's judgment\n6. The patient is agedā„18\n\nExclusion Criteria:\n\n1. The patient is known to be allergic to any study drug.\n2. The patient is recruited in other clinical study or is planned to participate into other clinical study.\n3. The patient has previously accepted chemotherapy against advanced or metastatic diseases (the patient may be recruited if the previous adjuvant therapy/neoadjuvant therapy was completed more than 6 months before inclusion)."}, 'identificationModule': {'nctId': 'NCT01472250', 'briefTitle': 'A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in China', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in China', 'orgStudyIdInfo': {'id': 'CGOG1002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chemotherapy', 'description': "Eligible patients will accept generalized chemotherapy according to the investigator's assessment.", 'interventionNames': ['Drug: Clinical chemo-drugs']}], 'interventions': [{'name': 'Clinical chemo-drugs', 'type': 'DRUG', 'description': "Clinical drugs will be selected by the investigator according to recommendations in Chinese and foreign guidelines and depending on clinical experience and the patient's individual conditions, including but not limited to the drugs listed below:\n\nPlatinum products: oxaliplatin, cisplatin Fluorouracil products: 5-fluorouracil, capecitabine, TS-1 Taxanes: paclitaxel, docetaxel", 'armGroupLabels': ['chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Lin Shen', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief of department of GI oncology', 'investigatorFullName': 'Shen Lin', 'investigatorAffiliation': 'Peking University'}}}}