Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-21 @ 11:40 AM
Study NCT ID:
NCT01667302
Status:
UNKNOWN
Last Update Posted:
2013-03-05
First Post:
2012-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiotherapy Followed by Adjuvant Chemotherapy in 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'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005047', 'term': 'Etoposide'}, {'id': 'C042705', 'term': 'pegaspargase'}], 'ancestors': [{'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-02', 'studyFirstSubmitDate': '2012-08-13', 'studyFirstSubmitQcDate': '2012-08-15', 'lastUpdatePostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year Progression-free survival', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '3 years'}, {'measure': '3-year overall survival', 'timeFrame': '3 years'}, {'measure': 'Safety', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NK/T-cell lymphoma', 'Radiotherapy', 'Adjuvant chemotherapy'], 'conditions': ['Extranodal NK/T-cell Lymphoma, Nasal Type']}, 'referencesModule': {'references': [{'pmid': '32519518', 'type': 'DERIVED', 'citation': 'Liu Y, Xue K, Xia Z, Jin J, Wang J, Sun H, Lv F, Liu X, Cao J, Hong X, Guo Y, Ma X, Zhang Q. Radiotherapy followed by DICEP regimen in treatment of newly diagnosed, stage IE/IIE, extranodal NK/T-cell lymphoma patients. Cancer Med. 2020 Aug;9(15):5400-5405. doi: 10.1002/cam4.3207. Epub 2020 Jun 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and tolerability of radiotherapy followed by adjuvant chemotherapy in stage I/II NK/T-cell lymphoma.', 'detailedDescription': 'For patients with stage I/II NK/T-cell lymphoma, the sequence of radiotherapy and chemotherapy is controversial. Some studies demonstrated the advantage of upfront radiotherapy. Therefore, we designed this single-arm phase II study to evaluate the efficacy and safety of radiotherapy followed by adjuvant chemotherapy with DICE regimen plus peg-asparaginase which was proved to be effective in NK/T-cell lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range 14-70 years old\n* Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract\n* ECOG performance status 0-1\n* Life expectancy of more than 3 months\n* Without prior history of pancreatitis\n* Adequate bone marrow and organ functions\n\nExclusion Criteria:\n\n* Low risk population (Definition: stage I without local invasion, B symptoms and high LDH level)\n* Pregnant or lactating women\n* With contraindication of steroid including uncontrolled diabetes\n* Serious uncontrolled diseases and intercurrent infection\n* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix'}, 'identificationModule': {'nctId': 'NCT01667302', 'briefTitle': 'Radiotherapy Followed by Adjuvant Chemotherapy in NK/T-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Phase II Study of Radiotherapy Followed by Chemotherapy With DICEP Regimen in Patients With NK/T-cell Lymphoma', 'orgStudyIdInfo': {'id': 'LMTG 12-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiotherapy followed by chemotherapy', 'description': 'Radiotherapy Technique: IMRT Total dose: 50 Gy Per fraction: 2 Gy Chemotherapy: q3w Dexamethasone 40 mg d1-4 Ifosfamide 1200mg/m2 d1-4 Etoposide 60 mg/m2 d1-4 Cisplatin 20mg/m2 d1-4 Peg-asparaginase 2000 IU/m2 d1', 'interventionNames': ['Drug: Radiotherapy followed by chemotherapy']}], 'interventions': [{'name': 'Radiotherapy followed by chemotherapy', 'type': 'DRUG', 'otherNames': ['DXM, IFO, VP-16, DDP, PEG-ASP'], 'description': 'Radiotherapy Technique: IMRT Total dose: 50 Gy Per fraction: 2 Gy Chemotherapy: q3w Dexamethasone 40 mg d1-4 Ifosfamide 1200mg/m2 d1-4 Etoposide 60 mg/m2 d1-4 Cisplatin 20mg/m2 d1-4 Peg-asparaginase 2000 IU/m2 d1', 'armGroupLabels': ['Radiotherapy followed by chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ye Guo, MD', 'role': 'CONTACT', 'email': 'pattrick_guo@msn.com', 'phone': '862164175590'}], 'facility': 'Fudan University Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ye Guo, MD', 'role': 'CONTACT', 'email': 'pattrick_guo@msn.com', 'phone': '862164175590'}], 'overallOfficials': [{'name': 'Ye Guo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assocaite Director of Medical Oncology Department', 'investigatorFullName': 'Ye Guo', 'investigatorAffiliation': 'Fudan University'}}}}