Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT00133302
Status:
TERMINATED
Last Update Posted:
2007-01-18
First Post:
2005-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Standard CHOP Versus Biweekly CHOP in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 450}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1999-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-08', 'completionDateStruct': {'date': '2005-02'}, 'lastUpdateSubmitDate': '2007-01-17', 'studyFirstSubmitDate': '2005-08-22', 'studyFirstSubmitQcDate': '2005-08-22', 'lastUpdatePostDateStruct': {'date': '2007-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival'}], 'secondaryOutcomes': [{'measure': 'Overall survival'}, {'measure': 'Complete remission rate'}, {'measure': 'Toxicity'}]}, 'conditionsModule': {'keywords': ["Non-Hodgkin's lymphoma", 'intermediate-grade lymphoma', 'high-grade lymphoma', 'CHOP protocol', 'granulocyte-colony stimulating factor'], 'conditions': ["Non-Hodgkin's Lymphoma"]}, 'referencesModule': {'references': [{'pmid': '21196441', 'type': 'DERIVED', 'citation': "Ohmachi K, Tobinai K, Kobayashi Y, Itoh K, Nakata M, Shibata T, Morishima Y, Ogura M, Suzuki T, Ueda R, Aikawa K, Nakamura S, Fukuda H, Shimoyama M, Hotta T; members of the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG). Phase III trial of CHOP-21 versus CHOP-14 for aggressive non-Hodgkin's lymphoma: final results of the Japan Clinical Oncology Group Study, JCOG 9809. Ann Oncol. 2011 Jun;22(6):1382-1391. doi: 10.1093/annonc/mdq619. Epub 2010 Dec 31."}], 'seeAlsoLinks': [{'url': 'http://www.jcog.jp/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "The purpose of this trial is to investigate the clinical benefit of the dose intensified regimen, Bi-CHOP in comparison to standard CHOP for advanced intermediate or high grade non-Hodgkin's lymphoma (NHL).", 'detailedDescription': 'The purpose of JCOG9809 was to determine whether treatment results of aggressive NHL could be improved by shortening intervals of CHOP chemotherapy with the prophylactic use of G-CSF. The primary endpoint was Progression Free Survival (PFS), and the planned accrual was 450. Until December, 2002, 323 patients with advanced aggressive NHL were randomized to standard CHOP arm (CHOP x 8, every three weeks) and biweekly CHOP arm (CHOP x 8, every two weeks).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Intermediate- or high-grade non-Hodgkin's lymphoma, excluding cutaneous t-cell lymphoma (CTCL), adult T-cell leukemia-lymphoma (ATL) and T-cell lymphoblastic lymphoma (T-LbL) (Working Formulation)\n* Ann Arbor stage: II, III, IV\n* No prior chemotherapy or radiotherapy\n* Age: 15 to 69\n* Performance status (PS): 0, 1, 2\n* WBC \\>= 3,000 /mm3, ANC \\>= 1,200 /mm3, Platelet \\>= 75,000 /mm3\n* GOT/GPT \\<= 5 x Normal Upper Limit, T-Bil \\<= 2.0 mg/dL\n* Creatinine \\<= 2.0 mg/dL\n* Normal ECG, Ejection Fraction \\>= 50%\n* PaO2 \\>= 65 mmHg\n* Written informed consent\n\nExclusion Criteria:\n\n* Uncontrollable diabetes mellitus\n* Severe complication (infection, heart failure, renal failure, liver failure, etc)\n* Anamnesis of heart disease\n* Acute or chronic hepatitis, liver cirrhosis and portal hypertension\n* Synchronous or metachronous malignancy\n* Severe pulmonary dysfunction\n* Central nervous system (CNS) invasion\n* HIV positive\n* Hepatitis B surface antigen (HBs-Ag) positive\n* Hepatitis C virus antibody (HCV-Ab) positive"}, 'identificationModule': {'nctId': 'NCT00133302', 'briefTitle': "Study of Standard CHOP Versus Biweekly CHOP in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)", 'organization': {'class': 'OTHER', 'fullName': 'Japan Clinical Oncology Group'}, 'officialTitle': "Randomized Phase III Study of Standard CHOP (S-CHOP) Versus Biweekly CHOP (Bi-CHOP) in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)", 'orgStudyIdInfo': {'id': 'JCOG9809'}, 'secondaryIdInfos': [{'id': 'C000000036'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Standard CHOP', 'type': 'DRUG'}, {'name': 'Bi-CHOP (dose intensified CHOP)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '259-1193', 'city': 'Isehara', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Tokai University', 'geoPoint': {'lat': 35.39932, 'lon': 139.31019}}], 'overallOfficials': [{'name': 'Tomomitsu Hotta, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tokai University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Japan Clinical Oncology Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Labour and Welfare, Japan', 'class': 'OTHER_GOV'}]}}}