Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-31 @ 6:13 AM
Study NCT ID:
NCT02317757
Status:
UNKNOWN
Last Update Posted:
2016-04-04
First Post:
2014-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predisposing Factors Associated With Chemotherapy Toxicity in Elderly Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-31', 'studyFirstSubmitDate': '2014-12-11', 'studyFirstSubmitQcDate': '2014-12-11', 'lastUpdatePostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'predisposing factors of patients developed grade 3 or 4 chemotherapy toxicity', 'timeFrame': 'from starting chemotherapy to 1 month after last dose of chemotherapy'}], 'secondaryOutcomes': [{'measure': 'incidence of grade 3 or 4 chemotherapy toxicity in elderly', 'timeFrame': 'from starting chemotherapy to 1 month after last dose of chemotherapy'}, {'measure': 'Factors associated with good quality of life during receiving chemotherapy', 'timeFrame': 'from starting chemotherapy to 1 month after last dose of chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['elderly cancer patients, chemotherapy toxicity'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'These days, there is higher proportion of elderly cancer patients. Most of them have comorbidities, borderline performance status and nutritional status. The discontinuation of chemotherapy due to unbearable toxicities was not uncommon. Comprehensive geriatric assessment might be beneficial in selection of suitable elderly patients for chemotherapy administration.', 'detailedDescription': 'The patients with the age more than 70 years old who scheduled for chemotherapy were enrolled. Geriatric assessment was performed before starting chemotherapy. The toxicity will be recorded prospectively. Predisposing factors of grade 3 and 4 toxicity will be reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'cancer patients who are older than 70 years old and receiving chemotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* more than 70 years of age\n* plan to receive first cycle of chemotherapy\n* histologically or cytologically proved of cancer\n\nExclusion Criteria:\n\n* patients who have concurrent chemoradiotherapy\n* patients who received local chemotherapy'}, 'identificationModule': {'nctId': 'NCT02317757', 'briefTitle': 'Predisposing Factors Associated With Chemotherapy Toxicity in Elderly Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Predisposing Factors Associated With Chemotherapy Toxicity in Elderly Cancer Patients: A Prospective Study', 'orgStudyIdInfo': {'id': '559/2557(EC3)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cancer patients receiving chemotherapy', 'description': 'Patients who are older than 70 years old receiving chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Suthinee Ithimakin, MD', 'role': 'CONTACT', 'email': 'aesi105@yahoo.co.th', 'phone': '662-419-4489'}, {'name': 'Suthinee Ithimakin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Varalak Srinonprasert, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Division of medical oncology, department of medicine Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Suthinee Ithimakin, MD', 'role': 'CONTACT', 'email': 'Aesi105@yahoo.co.th', 'phone': '66898127440'}], 'overallOfficials': [{'name': 'Suthinee Ithimakin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}