Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-25 @ 4:37 PM
Study NCT ID:
NCT02733458
Status:
COMPLETED
Last Update Posted:
2021-09-14
First Post:
2016-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GELAD Chemotherapy and Sandwiched Radiotherapy in the Treatment of Stage IE/IIE Natural Killer/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': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C042705', 'term': 'pegaspargase'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'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'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2016-04-05', 'studyFirstSubmitQcDate': '2016-04-05', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response rate', 'timeFrame': '28 days after 4 cycles of chemotherapy', 'description': 'The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.'}], 'secondaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': '2-year', 'description': 'Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.'}, {'measure': 'Overall Response rate', 'timeFrame': '28 days after 4 cycles of chemotherapy', 'description': 'The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.'}, {'measure': 'Treatment-Related Adverse Events as Assessed by CTCAE v4.0', 'timeFrame': 'Day 1 of each course and then every 3 months for 2 years', 'description': 'Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.'}, {'measure': 'Overall survival', 'timeFrame': '2-year', 'description': 'Overall survival is defiend as the time from entry onto the treatment until death of any reason'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Extranodal NK-T-Cell Lymphoma, Nasal Type']}, 'referencesModule': {'references': [{'pmid': '34806163', 'type': 'DERIVED', 'citation': 'Zhu Y, Tian S, Xu L, Ma Y, Zhang W, Wang L, Jin L, Liu C, Zhu C, Li Z, Hao S, Zhong H, Ding H, Tao R. GELAD chemotherapy with sandwiched radiotherapy for patients with newly diagnosed stage IE/IIE natural killer/T-cell lymphoma: a prospective multicentre study. Br J Haematol. 2022 Feb;196(4):939-946. doi: 10.1111/bjh.17960. Epub 2021 Nov 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of gemcitabine, etoposide, pegaspargase and dexamethasone (GELAD) chemotherapy and sandwiched radiotherapy as first-line treatment in patients with de novo stage IE/IIE extranodal natural killer/T-cell lymphoma, nasal type.', 'detailedDescription': 'Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of non-Hodgkin lymphoma (NHL) with relatively high incidence in China. Radiotherapy alone for stage IE/IIE diseases has good response rate but with high relapse rates, ranging from 20-50%. The combination of chemotherapy and radiotherapy improved the long-term survival for patients with stage IE/IIE diseases. But the optimal treatment schedule has not been established. This study is designed with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with additional two cycles GELAD chemotherapy. The efficacy and safety of this sandwiched chemoradiotherapy in the treatment of stage IE/IIE ENKTCL will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type, previously untreated\n* Eastern Cooperative Oncology Group (ECOG ) performance status 0\\~3\n* Stage IE to IIE disease with at least one measurable lesion in the nasal cavity, paranasal sinuses, orbit, pharynx, Waldeyer's ring, or oral cavity.\n* Preserved organ functions for: absolute neutrophil counter (ANC)\\>1.0×109/L, Platelet\\>50×109/L, hemoglobin\\>80g/L, total bilirubin (TBIL)\\<2×ULN, alanine transaminase (ALT)\\<2×ULN, serum creatinine\\<1.5×ULN，fibrinogen≥1.0g/L, LVEF≥50%\n* No history of chemotherapy or radiotherapy.\n* Signed Informed consented\n\nExclusion Criteria:\n\n* Concurrent cancers need surgery or chemotherapy within 6 months.\n* Significant complications: LVEF≤50%, coagulopathy, autoimmune disease, severe infection, or liver cirrhosis, hemophagocytic lymphohistiocytosis.\n* Mental disorders.\n* Pregnant or lactation\n* HIV, hepatitis virus C (HCV), or active hepatitis virus B (HBV) infection with HBV DNA≥105 copies/ml.\n* History of pancreatitis\n* Known history for grade 3/4 allergy to the drugs in chemotherapy regimen.\n* Enrolled in other trial treatment"}, 'identificationModule': {'nctId': 'NCT02733458', 'briefTitle': 'GELAD Chemotherapy and Sandwiched Radiotherapy in the Treatment of Stage IE/IIE Natural Killer/T-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'The Efficacy and Safety of Gemcitabine, Etoposide, Dexamethasone and Pegaspargase Chemotherapy (GELAD) With Sandwiched Radiotherapy in the Treatment of Stage IE/II Natural Killer/T-Cell Lymphoma: A Multicenter, Prospective Study', 'orgStudyIdInfo': {'id': 'XHLSG-NK-1601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GELAD/Radiation', 'description': 'Patients will be initially treated with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with another two cycles GELAD chemotherapy. GELAD chemotherapy will be repeated every 21 days. Radiotherapy will be delivered in 25-32 fractions.', 'interventionNames': ['Drug: GELAD', 'Radiation: Radiotherapy']}], 'interventions': [{'name': 'GELAD', 'type': 'DRUG', 'otherNames': ['Gemcitabine, Etoposide, Dexamethasone, Pegaspargase'], 'description': 'Gemcitabine, 1.0g/m2/d IV, day 1 Etoposide, 60mg/m2 IV, day 1 to day 3 Dexamethasone, 40mg/d IV, day 1 to day 4 Pegaspargase, 2000IU/m2/d IM, day 4', 'armGroupLabels': ['GELAD/Radiation']}, {'name': 'Radiotherapy', 'type': 'RADIATION', 'description': 'Radiotherapy: 50-56Gy', 'armGroupLabels': ['GELAD/Radiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200120', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Dong Fang hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201100', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Department of Hematology, Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201100', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'South Renji hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '830001', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': "Xin Jiang People's Hospital", 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '200011', 'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai Ninth Peoples' Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200031', 'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Eye and ENT Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Xinhua Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Rong Tao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xinhua hospital, Shanghai Jiao Tong University of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Rong Tao', 'investigatorAffiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}}}}