Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-30 @ 7:54 AM
Study NCT ID:
NCT00039351
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2002-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Older Patients With Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D007119', 'term': 'Immunoblastic Lymphadenopathy'}], 'ancestors': [{'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'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D000072281', 'term': 'Lymphadenopathy'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'lastUpdateSubmitDate': '2012-09-20', 'studyFirstSubmitDate': '2002-06-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2012-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage I adult diffuse large cell lymphoma', 'stage III adult diffuse large cell lymphoma', 'stage IV adult diffuse large cell lymphoma', 'contiguous stage II adult diffuse large cell lymphoma', 'noncontiguous stage II adult diffuse large cell lymphoma', 'angioimmunoblastic T-cell lymphoma'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older patients who have non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\n* Determine the complete remission (CR) rate and duration of CR in frail elderly patients with diffuse large B-cell or peripheral T-cell non-Hodgkin's lymphoma treated with cyclophosphamide, vincristine, and prednisone.\n* Determine the time to progression and overall survival of patients treated with this regimen.\n* Determine the severe toxicity rate of this regimen in these patients.\n* Assess the quality of life of patients treated with this regimen.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive cyclophosphamide IV and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients with stage I or II non-Hodgkin's lymphoma (NHL), no baseline lactate dehydrogenase (LDH) elevation, baseline WHO performance status 0-1, and longest tumor diameter of less than 5 cm, who achieve partial response (PR) or complete response (CR), receive 1 additional course of chemotherapy. Patients then undergo involved-field radiotherapy once daily 5 days a week for 3.5-4 weeks.\n\nPatients with stage I or II NHL, a baseline LDH elevation, and/or baseline WHO performance status 2-4, and/or longest tumor diameter of at least 5 cm, who achieve PR or CR, receive 3 additional courses of chemotherapy. Patients then undergo involved-field radiotherapy once daily 5 days a week for 3.5-4 weeks.\n\nPatients with stage III or IV NHL who achieve CR or PR receive 3 additional courses of chemotherapy. Patients then undergo consolidative radiotherapy once daily 5 days a week for 2.5-3 weeks.\n\nQuality of life is assessed at baseline, after the third chemotherapy course, at the end of chemotherapy, every 6 months for 3 years, and then annually thereafter.\n\nPatients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 29-56 patients will be accrued for this study within 12-18 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Diagnosis of diffuse large B-cell or peripheral T-cell non-Hodgkin's lymphoma (NHL)\n\n * No Burkitt's-like lymphoma\n * Small cells in bone marrow allowed\n* Previously untreated NHL\n* At least 1 measurable lesion\n\n * At least 1.1 cm\n* Poor physiological status with at least 1 of the following:\n\n * WHO performance status of 3-4\n * LVEF less than 50%\n * Creatinine clearance less than 50 mL/min\n * Neutrophil count no greater than 1,500/mm\\^3\n * Platelet count no greater than 100,000/mm\\^3\n * Concurrent severe disease that would preclude cyclophosphamide, vincristine, prednisolone, and doxorubicin\n* No cerebral or meningeal involvement\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 70 and over\n\nPerformance status:\n\n* See Disease Characteristics\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* See Disease Characteristics\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* See Disease Characteristics\n\nOther:\n\n* HIV negative\n* No other malignancy within the past 5 years except adequately treated basal cell skin cancer, curatively treated carcinoma in situ of the cervix, or curatively treated solid tumor\n* No active infection\n* No psychological, familial, sociological, or geographical condition that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No other concurrent investigational drugs\n* No other concurrent antineoplastic agents"}, 'identificationModule': {'nctId': 'NCT00039351', 'briefTitle': "Combination Chemotherapy in Treating Older Patients With Non-Hodgkin's Lymphoma", 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': "Diffuse Large B Cell And Peripheral T-Cell Non-Hodgkin's Lymphoma In The Frail Elderly. Progressive And Cautious Treatment Strategy In Poor Status Patients. A Phase II Trial With Emphasis On Geriatric Assessment And Quality Of Life", 'orgStudyIdInfo': {'id': 'EORTC-20992'}, 'secondaryIdInfos': [{'id': 'EORTC-20992'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cyclophosphamide', 'type': 'DRUG'}, {'name': 'prednisone', 'type': 'DRUG'}, {'name': 'vincristine sulfate', 'type': 'DRUG'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Ziekenhuis Network Antwerpen Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': 'B 1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'U.Z. Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'National Cancer Institute of Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': 'F-64100', 'city': 'Bayonne', 'country': 'France', 'facility': "Centre D'Oncologie Du Pays-Basque", 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '33075', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hopital Saint Andre', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '40107', 'city': 'Dax', 'country': 'France', 'facility': 'Centre Hospitalier de Dax', 'geoPoint': {'lat': 43.71032, 'lon': -1.05366}}, {'zip': '33500', 'city': 'Libourne', 'country': 'France', 'facility': 'Hopital Robert Boulin', 'geoPoint': {'lat': 44.91449, 'lon': -0.24186}}, {'zip': '24004', 'city': 'Périgueux', 'country': 'France', 'facility': 'Polyclinique de Francheville', 'geoPoint': {'lat': 45.18691, 'lon': 0.71439}}, {'zip': '1091 HA', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Onze Lieve Vrouwe Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '9700 RB', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': 'NL-6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'University Medical Center Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3001-301', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Hospitais da Universidade de Coimbra (HUC)', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': 'CH-1226', 'city': 'Thonex-Geneve', 'country': 'Switzerland', 'facility': 'Hopitaux Universitaires de Geneve'}, {'zip': 'WV10 0QP', 'city': 'Wolverhampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'New Cross Hospital', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}, {'zip': 'DG1 4AP', 'city': 'Dumfries', 'country': 'United Kingdom', 'facility': 'Dumfries Royal Infirmary', 'geoPoint': {'lat': 55.06959, 'lon': -3.61139}}], 'overallOfficials': [{'name': 'Pierre Soubeyran, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut Bergonié'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}