Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
Study NCT ID:
NCT04522050
Status:
UNKNOWN
Last Update Posted:
2023-07-12
First Post:
2020-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gemcitabine-based Induction Chemotherapy Combined With Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059248', 'term': 'Chemoradiotherapy'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The initial dose of gemcitabine is 25mg/m² once a week for 6 times. The patients are divided into 9 groups (25mg/m², 50mg/m², 100mg/m², 200mg/m², 300mg/m², 350mg/m², 400mg/m², 450mg/m², 500mg/m²) with 6 patients in each group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-11', 'studyFirstSubmitDate': '2020-08-15', 'studyFirstSubmitQcDate': '2020-08-20', 'lastUpdatePostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerance dose(MTD)', 'timeFrame': '3 years', 'description': 'MTD is detemined by the dose that is immediately lower than the dose that produced dose limiting toxicity （DLT）. If DLT occurs in more than half of patients at a certain dose level, the test will be terminated. If DLT occurs in 2 cases,another 6 patients will be treated with this dose. If DLT does not occur in 6 cases, the dose will continue to increase. If it still occurs, the next dose is MTD.'}], 'secondaryOutcomes': [{'measure': 'Dose limiting toxicity (DLT)', 'timeFrame': '3 years', 'description': 'We determined DLT: a) grade ≥ 3 anemia; b) grade ≥ 3 thrombocytopenia; c) grade ≥ 3 neutropenia no less than 5 days, d) grade 3 febrile neutropenia (absolute neutrophil count \\< 1.0 x 10\\^9/L, fever ≥ 38.5℃) despite therapy with granulocyte colony-stimulating factor; and e) any other grades 3-4 toxicity (except alopecia and nausea).'}, {'measure': 'Tumor response rates', 'timeFrame': '3 years', 'description': 'Tumor response rate was evaluated according to the RECIST1.1. After induction chemotherapy, radiotherapy and 3 months, 1 year, 2 years, and 3 years of radiotherapy, nasal endoscope and magnetic resonance imaging results were used to evaluate the efficacy. And chest CT scanning, abdominal ultrasound, bone scan or PETCT examination were used to exclude the distant metastases. Pathologic biopsy can be performed for patients who are suspected of locally residual or recurrence.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasopharyngeal Carcinoma']}, 'referencesModule': {'references': [{'pmid': '16822324', 'type': 'BACKGROUND', 'citation': 'Jia WH, Huang QH, Liao J, Ye W, Shugart YY, Liu Q, Chen LZ, Li YH, Lin X, Wen FL, Adami HO, Zeng Y, Zeng YX. Trends in incidence and mortality of nasopharyngeal carcinoma over a 20-25 year period (1978/1983-2002) in Sihui and Cangwu counties in southern China. BMC Cancer. 2006 Jul 6;6:178. doi: 10.1186/1471-2407-6-178.'}, {'pmid': '27577729', 'type': 'BACKGROUND', 'citation': 'Zeng Q, Wang J, Lv X, Li J, Yin LJ, Xiang YQ, Guo X. Induction Chemotherapy Followed by Radiotherapy versus Concurrent Chemoradiotherapy in elderly patients with nasopharyngeal carcinoma: finding from a propensity-matched analysis. BMC Cancer. 2016 Aug 30;16(1):693. doi: 10.1186/s12885-016-2661-y.'}, {'pmid': '27478316', 'type': 'BACKGROUND', 'citation': 'Meng R, Wei K, Xia L, Xu Y, Chen W, Zheng R, Lin L. Cancer incidence and mortality in Guangdong province, 2012. Chin J Cancer Res. 2016 Jun;28(3):311-20. doi: 10.21147/j.issn.1000-9604.2016.03.05.'}, {'pmid': '22995588', 'type': 'BACKGROUND', 'citation': 'Peng G, Wang T, Yang KY, Zhang S, Zhang T, Li Q, Han J, Wu G. A prospective, randomized study comparing outcomes and toxicities of intensity-modulated radiotherapy vs. conventional two-dimensional radiotherapy for the treatment of nasopharyngeal carcinoma. Radiother Oncol. 2012 Sep;104(3):286-93. doi: 10.1016/j.radonc.2012.08.013. Epub 2012 Sep 17.'}, {'pmid': '26318726', 'type': 'BACKGROUND', 'citation': 'Zhang MX, Li J, Shen GP, Zou X, Xu JJ, Jiang R, You R, Hua YJ, Sun Y, Ma J, Hong MH, Chen MY. Intensity-modulated radiotherapy prolongs the survival of patients with nasopharyngeal carcinoma compared with conventional two-dimensional radiotherapy: A 10-year experience with a large cohort and long follow-up. Eur J Cancer. 2015 Nov;51(17):2587-95. doi: 10.1016/j.ejca.2015.08.006. Epub 2015 Aug 26.'}, {'pmid': '26093812', 'type': 'BACKGROUND', 'citation': 'Huang PY, Zeng Q, Cao KJ, Guo X, Guo L, Mo HY, Wu PH, Qian CN, Mai HQ, Hong MH. Ten-year outcomes of a randomised trial for locoregionally advanced nasopharyngeal carcinoma: A single-institution experience from an endemic area. Eur J Cancer. 2015 Sep;51(13):1760-70. doi: 10.1016/j.ejca.2015.05.025. Epub 2015 Jun 17.'}, {'pmid': '27686945', 'type': 'BACKGROUND', 'citation': 'Sun Y, Li WF, Chen NY, Zhang N, Hu GQ, Xie FY, Sun Y, Chen XZ, Li JG, Zhu XD, Hu CS, Xu XY, Chen YY, Hu WH, Guo L, Mo HY, Chen L, Mao YP, Sun R, Ai P, Liang SB, Long GX, Zheng BM, Feng XL, Gong XC, Li L, Shen CY, Xu JY, Guo Y, Chen YM, Zhang F, Lin L, Tang LL, Liu MZ, Ma J. Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial. Lancet Oncol. 2016 Nov;17(11):1509-1520. doi: 10.1016/S1470-2045(16)30410-7. Epub 2016 Sep 27.'}, {'pmid': '26321262', 'type': 'BACKGROUND', 'citation': 'Chua MLK, Wee JTS, Hui EP, Chan ATC. Nasopharyngeal carcinoma. Lancet. 2016 Mar 5;387(10022):1012-1024. doi: 10.1016/S0140-6736(15)00055-0. Epub 2015 Aug 28.'}, {'pmid': '28202000', 'type': 'BACKGROUND', 'citation': 'Ke LR, Xia WX, Qiu WZ, Huang XJ, Yang J, Yu YH, Liang H, Liu GY, Ye YF, Xiang YQ, Guo X, Lv X. Safety and efficacy of lobaplatin combined with 5-fluorouracil as first-line induction chemotherapy followed by lobaplatin-radiotherapy in locally advanced nasopharyngeal carcinoma: preliminary results of a prospective phase II trial. BMC Cancer. 2017 Feb 15;17(1):134. doi: 10.1186/s12885-017-3080-4.'}, {'pmid': '29501366', 'type': 'BACKGROUND', 'citation': 'Tang LQ, Chen DP, Guo L, Mo HY, Huang Y, Guo SS, Qi B, Tang QN, Wang P, Li XY, Li JB, Liu Q, Gao YH, Xie FY, Liu LT, Li Y, Liu SL, Xie HJ, Liang YJ, Sun XS, Yan JJ, Wu YS, Luo DH, Huang PY, Xiang YQ, Sun R, Chen MY, Lv X, Wang L, Xia WX, Zhao C, Cao KJ, Qian CN, Guo X, Hong MH, Nie ZQ, Chen QY, Mai HQ. Concurrent chemoradiotherapy with nedaplatin versus cisplatin in stage II-IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol. 2018 Apr;19(4):461-473. doi: 10.1016/S1470-2045(18)30104-9. Epub 2018 Feb 28.'}, {'pmid': '26712958', 'type': 'BACKGROUND', 'citation': 'Vanderveken OM, Szturz P, Specenier P, Merlano MC, Benasso M, Van Gestel D, Wouters K, Van Laer C, Van den Weyngaert D, Peeters M, Vermorken J. Gemcitabine-Based Chemoradiation in the Treatment of Locally Advanced Head and Neck Cancer: Systematic Review of Literature and Meta-Analysis. Oncologist. 2016 Jan;21(1):59-71. doi: 10.1634/theoncologist.2015-0246. Epub 2015 Dec 28.'}, {'pmid': '27567279', 'type': 'BACKGROUND', 'citation': 'Zhang L, Huang Y, Hong S, Yang Y, Yu G, Jia J, Peng P, Wu X, Lin Q, Xi X, Peng J, Xu M, Chen D, Lu X, Wang R, Cao X, Chen X, Lin Z, Xiong J, Lin Q, Xie C, Li Z, Pan J, Li J, Wu S, Lian Y, Yang Q, Zhao C. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial. Lancet. 2016 Oct 15;388(10054):1883-1892. doi: 10.1016/S0140-6736(16)31388-5. Epub 2016 Aug 23.'}, {'pmid': '10421547', 'type': 'BACKGROUND', 'citation': 'Mason KA, Milas L, Hunter NR, Elshaikh M, Buchmiller L, Kishi K, Hittelman K, Ang KK. Maximizing therapeutic gain with gemcitabine and fractionated radiation. Int J Radiat Oncol Biol Phys. 1999 Jul 15;44(5):1125-35. doi: 10.1016/s0360-3016(99)00134-0.'}, {'pmid': '9892194', 'type': 'BACKGROUND', 'citation': 'Milas L, Fujii T, Hunter N, Elshaikh M, Mason K, Plunkett W, Ang KK, Hittelman W. Enhancement of tumor radioresponse in vivo by gemcitabine. Cancer Res. 1999 Jan 1;59(1):107-14.'}, {'pmid': '22678924', 'type': 'BACKGROUND', 'citation': 'El Deen DA, Toson EA, El Morsy SM. Gemcitabine-based induction chemotherapy and concurrent with radiation in advanced head and neck cancer. Med Oncol. 2012 Dec;29(5):3367-73. doi: 10.1007/s12032-012-0269-x. Epub 2012 Jun 8.'}, {'pmid': '23043985', 'type': 'BACKGROUND', 'citation': 'Aguilar-Ponce JL, Granados-Garcia M, Cruz Lopez JC, Maldonado-Magos F, Alvarez-Avitia MA, Arrieta O, Gonzalez-Ramirez I, Lara-Cruz G, Martinez-Juarez I, Medina-Santillan R, Castillo-Hernandez C, De la Garza-Salazar J. Alternating chemotherapy: gemcitabine and cisplatin with concurrent radiotherapy for treatment of advanced head and neck cancer. Oral Oncol. 2013 Mar;49(3):249-54. doi: 10.1016/j.oraloncology.2012.09.008. Epub 2012 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'Researchers conduct the clinical trial (gemcitabine combined with cisplatin induction chemotherapy followed by concurrent chemoradiotherapy with gemcitabine for locally advanced nasopharyngeal carcinoma) to evaluate the safety and effectiveness of gemcitabine in patients with locally advanced nasopharyngeal carcinoma.', 'detailedDescription': 'Diagnosed as locally advanced nasopharyngeal carcinoma (stage III-IV), and pathologically confirmed as a differentiated or undifferentiated non-keratinizing nasopharyngeal carcinoma, the patient is eligible to participate in the study. Patients receive gemcitabine (1000mg/m² d1,8) and cisplatin (80mg/m², d1) every 3 weeks for 2 cycles before radiotherapy. And then intensity modulated radiotherapy (IMRT) is given a total dose of GTVnx 70Gy, GTVnd 66Gy, CTV1 60Gy and CTV2 54Gy for 33 times in total, concurrently with gemcitabine. The initial dose of gemcitabine is 25mg/m² once a week for 6 times. The patients are divided into 9 groups (25mg/m², 50mg/m², 100mg/m², 200mg/m², 300mg/m², 350mg/m², 400mg/m², 450mg/m², 500mg/m²) with 6 patients in each group. Considering about 20% of the cases of dropout, withdrawal, and loss to follow-up in clinical trials, a total of 65 cases are needed in this study. The efficacy is evaluated according to the European Solid Tumor Efficacy Evaluation Standard (RECIST1.1). After induction chemotherapy, radiotherapy, and 3 months after radiotherapy, nasopharyngeal endoscopy and magnetic resonance imaging of the would be reviewed for 1 year, 2 years, and 3 years to evaluate the curative effect. The chest CT, abdominal B-ultrasound, bone scan or PETCT examinations are reviewed to exclud distant metastases. Biopsy diagnosis can be performed for patients suspected of local residual and recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type)\n* Tumor staged as Ⅲ-Ⅳa (according to the 8th AJCC edition staging system)\n* Age :18-60\n* Performance status: KPS \\> 70\n* Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \\< 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) \\< 2.5×ULN, and bilirubin \\< ULN\n* Renal: creatinine clearance \\> 60ml/min\n* Adequate marrow: leucocyte count \\> 4×109/L, neutrophil count \\> 2×109/L, and platelet count \\> 100×109/L\n* Written informed consent\n\nExclusion Criteria:\n\n* History of allergy to related drugs\n* Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)\n* History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume)\n* Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes\n* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \\> 1.5×ULN), and emotional disturbance'}, 'identificationModule': {'nctId': 'NCT04522050', 'briefTitle': 'Gemcitabine-based Induction Chemotherapy Combined With Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Fifth Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'A Multicenter and Prospective Clinical Trial of Gemcitabine-based Induction Chemotherapy Combined With Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'ZDWY.TJZLK.111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Induction chemotherapy + IMRT and concurrent gemcitabine', 'description': 'Patients receive gemcitabine (1000mg/m² d1,8) and cisplatin (80mg/m²,d1) every 3weeks for 2 cycles before radiotherapy, and then receive intensity modulated radiotherapy (IMRT) concurrently with gemcitabine. The initial dose of gemcitabine is 25mg/m² once a week for 6 times. Patients are divided into 9 groups (25mg/m², 50mg/m², 100mg/m², 200mg/m², 300mg/m², 350mg/m², 400mg/m², 450mg/m², 500mg/m²) with 6 patients in each group.', 'interventionNames': ['Drug: Gemcitabine combined with cisplatin induction chemotherapy', 'Drug: concurrent chemoradiotherapy with gemcitabine']}], 'interventions': [{'name': 'Gemcitabine combined with cisplatin induction chemotherapy', 'type': 'DRUG', 'otherNames': ['concurrent chemoradiotherapy with gemcitabine'], 'description': 'Patients receive gemcitabine (1000mg/m² d1,8) and cisplatin (80mg/m², d1) every 3 weeks for 2 cycles before radiotherapy. And then intensity modulated radiotherapy (IMRT) is given a total dose of GTVnx 70Gy, GTVnd 66Gy, CTV1 60Gy and CTV2 54Gy for 33 times in total, concurrently with gemcitabine. The initial dose of gemcitabine is 25mg/m² once a week for 6 times. The patients are divided into 9 groups (25mg/m², 50mg/m², 100mg/m², 200mg/m², 300mg/m², 350mg/m², 400mg/m², 450mg/m², 500mg/m²) with 6 patients in each group.', 'armGroupLabels': ['Induction chemotherapy + IMRT and concurrent gemcitabine']}, {'name': 'concurrent chemoradiotherapy with gemcitabine', 'type': 'DRUG', 'description': 'followed by concurrent gemcitabine chemoradiotherapy', 'armGroupLabels': ['Induction chemotherapy + IMRT and concurrent gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '519000', 'city': 'Zhuhai', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qi Zeng, Doctor', 'role': 'CONTACT', 'email': 'zengqi37@mail.sysu.edu.cn', 'phone': '18898534065'}], 'facility': 'The Fifth Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 22.27694, 'lon': 113.56778}}], 'centralContacts': [{'name': 'qi zeng, Doctor', 'role': 'CONTACT', 'email': 'zengqi37@mail.sysu.edu.cn', 'phone': '18898534065'}, {'name': 'siyang wang, Doctor', 'role': 'CONTACT', 'email': '13570608929@163.com', 'phone': '13570608929'}], 'overallOfficials': [{'name': 'siyang wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fifth Affiliated Hospital, Sun Yat-Sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fifth Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Qi Zeng', 'investigatorAffiliation': 'Fifth Affiliated Hospital, Sun Yat-Sen University'}}}}