Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-29 @ 1:46 PM
Study NCT ID:
NCT00418535
Status:
COMPLETED
Last Update Posted:
2009-10-21
First Post:
2007-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Chemoradiation Followed by VIPD in Nasal Natural Killer (NK)/T-cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-20', 'studyFirstSubmitDate': '2007-01-03', 'studyFirstSubmitQcDate': '2007-01-03', 'lastUpdatePostDateStruct': {'date': '2009-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Lymphoma, NK/T-Cell'], 'conditions': ['Lymphoma, T-Cell']}, 'descriptionModule': {'briefSummary': "Nasal NK/T-cell lymphoma is a peculiar clinico-pathologic subtype of non-Hodgkin's lymphoma (NHL). Although most patients present with stage I/II, only 30-60% of the patients remain disease-free. The efficacy of the conventional anthracycline-based chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone \\[CHOPP\\]) has been unsatisfactory.\n\nThe optimal treatment of localized NK/T-cell lymphoma has not been defined yet. The optimal dose, sequence, and multi-modality treatment with involved field radiotherapy still need to be refined. This trial is to evaluate the efficacy of concurrent chemoradiotherapy with cisplatin followed by VIPD (etoposide, ifosfamide, cisplatin, dexamethasone) in localized NK/T-cell lymphoma patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed NK/T-cell lymphoma\n* Localized (Ann Arbor stage I/II) disease\n* At least one measurable lesion\n* Age \\> 18\n* ECOG performance status 0 - 2\n* Expected life span of at least 12 weeks\n* Normal marrow function (hemoglobin ≥ 9.0 g/dL; absolute neutrophil count ≥ 1,500/mm3; platelet count ≥ 100,000/mm3)\n* Normal liver function (total bilirubin \\< 2x upper limit of normal \\[ULN\\], transaminase \\< 3x ULN)\n* Normal renal function (serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 50 mL/min)\n* Written informed consent\n\nExclusion Criteria:\n\n* Other malignancies except for treated non-melanoma skin cancers and cervical cancer in situ\n* Serious medical illnesses (congestive heart failure, angina, respiratory failure, and renal failure)\n* Acute or active infection requiring intravenous (IV) antibiotics\n* Pregnant, lactating women\n* Previous history of chemotherapy or radiotherapy\n* Concomitant medication that may influence the study drugs\n* Allergic reaction to study drugs\n* Grade 2 or greater peripheral neuropathy'}, 'identificationModule': {'nctId': 'NCT00418535', 'briefTitle': 'Clinical Study of Chemoradiation Followed by VIPD in Nasal Natural Killer (NK)/T-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'A Phase II Study of Concurrent Chemoradiation Followed by VIPD (Etoposide/Ifosfamide/Cisplatin/Dexamethasone) in Stage I, II Nasal NK/T-cell Lymphoma', 'orgStudyIdInfo': {'id': '2004-10-08'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Concurrent Radiotherapy (RT)/cisplatin, VIPD', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Won Seog Kim, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, {'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Gyeongsang National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'CISL (Consortium to Improve Lymphoma Survival)', 'oldOrganization': 'CISL (Consortium to Improve Lymphoma Survival)'}}}}