Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-01 @ 11:09 AM
Study NCT ID:
NCT00921635
Status:
SUSPENDED
Last Update Posted:
2009-06-19
First Post:
2009-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Impact of Maintaining Hemoglobin Levels in Anemic Patients With Carcinoma of the Cervix
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001803', 'term': 'Blood Transfusion'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'lastUpdateSubmitDate': '2009-06-18', 'studyFirstSubmitDate': '2009-06-15', 'studyFirstSubmitQcDate': '2009-06-15', 'lastUpdatePostDateStruct': {'date': '2009-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The impact of maintaining hemoglobin levels above 120 g/L versus above 100 g/L', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Haemoglobin'], 'conditions': ['Cervical Cancer', 'Anemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the feasibility, safety and short term effects on health related quality of life, of maintaining hemoglobin from 120 to 130 g/L versus from 100 to 110 g/L, with red cell concentrate (RCC) transfusion, in women having chemo-radiation for cancer of the cervix.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previously untreated cervix cancer\n* FIGO stage IB2, II, IIIB, IVA\n* Suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation\n\nExclusion Criteria:\n\n* Hemoglobin level above 125g/L\n* Lower one-third vaginal involvement\n* Para-aortic lymphadenopathy'}, 'identificationModule': {'nctId': 'NCT00921635', 'acronym': 'HOSTT', 'briefTitle': 'A Study to Evaluate the Impact of Maintaining Hemoglobin Levels in Anemic Patients With Carcinoma of the Cervix', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': 'A Phase III Study to Evaluate the Impact of Maintaining Haemoglobin Levels Above 120g/L Verses Above 100g/L in Anaemic Patients With Carcinoma of the Cervix Receiving Concurrent Cisplatin and Radiation Therapy', 'orgStudyIdInfo': {'id': 'ANZGOG0401'}, 'secondaryIdInfos': [{'id': 'TSGHIRB095-05-044'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maintain hemoglobin level above 120 g/L', 'description': 'Hemoglobin level from 120 g/L to 130 g/L', 'interventionNames': ['Procedure: Blood transfusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Maintain hemoglobin level above 100 g/L', 'description': 'Hemoglobin level from 100 g/L to 110 g/L', 'interventionNames': ['Procedure: Blood transfusion']}], 'interventions': [{'name': 'Blood transfusion', 'type': 'PROCEDURE', 'description': 'Blood transfusion to maintain hemoglobin level above 120 g/L', 'armGroupLabels': ['Maintain hemoglobin level above 120 g/L']}, {'name': 'Blood transfusion', 'type': 'PROCEDURE', 'description': 'Blood transfusion to maintain hemoglobin level above 100 g/L', 'armGroupLabels': ['Maintain hemoglobin level above 100 g/L']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yee-Min Jen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Randiation Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Taiwan University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Yee-Min Jen/Head of the department of Radiation oncology', 'oldOrganization': 'Radiation oncology of Tri-Service General Hospital'}}}}