Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-27 @ 6:51 AM
Study NCT ID:
NCT01238159
Status:
COMPLETED
Last Update Posted:
2015-03-03
First Post:
2010-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concomitant Chemo-radiotherapy Followed by MIDLE Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054391', 'term': 'Lymphoma, Extranodal NK-T-Cell'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059248', 'term': 'Chemoradiotherapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-01', 'studyFirstSubmitDate': '2010-09-08', 'studyFirstSubmitQcDate': '2010-11-09', 'lastUpdatePostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response', 'timeFrame': 'Within 4 weeks after the completion of planned treatment', 'description': 'The response criteria was based on the International Working Group Report (1999).'}], 'secondaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': 'Up to 2 years', 'description': 'Overall response rate includes complete and partial response.'}, {'measure': 'overall survival', 'timeFrame': 'up to 2 years', 'description': 'Overall survival is defined as the time interval between the date of diagnosis and the date of death with any cause.'}, {'measure': 'Progression-free survival', 'timeFrame': 'up to 2 years', 'description': 'Progression-free survival is defined as the time interval between the the date of diagnosis and the date of death with any cause or disease progression/relapse.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Natural killer cell', 'T cell', 'Lymphoma', 'Radiation', 'Chemotherapy'], 'conditions': ['Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of concomitant chemoradiation followed by MIDLE chemotherapy for stage I/II extranodal NK/T cell lymphoma.', 'detailedDescription': 'Concomitant chemo-radiotherapy:\n\nRadiation 36-44 Gy/18-22 fractions (2 Gy/fraction) Weekly Cisplatin 30mg/m2 + N/S 100ml MIV over 30min Tri-weekly L-asparaginase 4000 IU IV (D1, 3, 5)\n\nRest period: 3 weeks\n\nMIDLE chemotherapy: Repeated every 28 days for 2 cycles D1 Methotrexate 3g/m2 + D5W 500ml MIV over 6 hours D2-D3 Etoposide 100mg/m2 + D5W 500ml MIV over 90mins D2-D3 Ifosfamide 1000mg/m2 + D5W 100ml MIV over 1hr D2-D3 Mesna 300mg/m2 + D5W 100ml MIV over 15mins (-15min, 4hrs and 8hrs after ifosfamide, total 3 doses) D1-D4 Dexamethasone 40mg/d PO or IV D4, 6, 8, 14, 10 L-asparaginase 6000IU/m2 + D5W 500ml MIV over 2hours'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients were required to have a biopsy-proven diagnosis of nasal ENKTL\n* at least 18 years old\n* Ann Arbor stage IE or IIE\n* measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 life expectancy greater than 12 weeks\n* adequate hematologic (hemoglobin \\> 9.0 g/dL, absolute neutrophil count \\> 1,500/uL and platelets \\> 100,000/uL)\n* renal (serum creatinine \\< 1.5 mg/dL, creatinine clearance \\> 50 mL/min)\n* hepatic (total bilirubin \\< 2 times of upper limit of normal and aspartate transferase \\< 3 times of upper limit of normal) function\n* Diagnosis of ENKTL is based on the presence of histological features and immunophenotypes compatible with ENKTL (e.g., cytoplasmic CD3+, CD20-, CD56+,\n* positive for cytotoxic molecules\n* positive for EBV by in situ hybridization).\n* Informed consent\n\nExclusion Criteria:\n\n* prior or concomitant malignant tumors\n* any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.\n* ENKTL with non-nasal sites such as skin or gastrointestinal tract was excluded even if it is localized.\n* Other subtypes of non-Hodgkin lymphoma (NHL), including myeloid/NK cell precursor acute leukemia, blastic NK cell lymphoma/precursor NK cell lymphoblastic leukemia, aggressive NK cell leukemia, and peripheral T cell lymphoma, unspecified, were excluded.'}, 'identificationModule': {'nctId': 'NCT01238159', 'briefTitle': 'Concomitant Chemo-radiotherapy Followed by MIDLE Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Open-labeled, Multicenter Phase II Study of Concomitant Chemo-radiotherapy Followed by MIDLE (Methotrexate, Ifosfamide, Dexamethasone, L-asparaginase, Etoposide) Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma', 'orgStudyIdInfo': {'id': '2010-06-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CCRT+MIDLE', 'description': 'Patients who are planned to be treated with CCRT plus MIDLE chemotherapy. CCRT means concurrent chemoradiation, and MIDLE represent systemic chemotherapy.', 'interventionNames': ['Radiation: CCRT+MIDLE chemotherapy']}], 'interventions': [{'name': 'CCRT+MIDLE chemotherapy', 'type': 'RADIATION', 'otherNames': ['Chemoradiotherapy'], 'description': 'Patients are planned to be treated with CCRT plus MIDLE chemotherapy', 'armGroupLabels': ['CCRT+MIDLE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Won Seog Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Yonsei University', 'class': 'OTHER'}, {'name': 'Seoul National University', 'class': 'OTHER'}, {'name': 'Chonnam National University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Kim, Seok Jin', 'investigatorAffiliation': 'Samsung Medical Center'}}}}