Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-03-07 @ 10:43 PM
Study NCT ID:
NCT01326559
Status:
COMPLETED
Last Update Posted:
2017-08-16
First Post:
2011-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil in Concurrence With Intensity-modulated Radiotherapy for Local Recurrent Nasopharyngeal Carcinoma (NPC)
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': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-13', 'studyFirstSubmitDate': '2011-03-22', 'studyFirstSubmitQcDate': '2011-03-29', 'lastUpdatePostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response rate', 'timeFrame': '5 years', 'description': 'Complete response rate is defined as the proportion of subjects with disappearance of all target lesions after induction and concurrent therapies.'}], 'secondaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '5 years', 'description': 'Defined as the proportion of subjects with best response (confirmed CR or PR) compared to the overall treated group.'}, {'measure': 'Locoregional and distant control rate', 'timeFrame': '5 years', 'description': 'Defined as the proportion of subjects with no local or nodal progression or recurrence and no distant disease progression or recurrence compared to the overall treated group.'}, {'measure': 'Progression free survival', 'timeFrame': '5 years', 'description': 'Defined as the time in months from first dose of cetuximab until PD is observed or death occurs due to any cause within 90 days after the last tumour assessment or first cetuximab dose.'}, {'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'Defined as the time in months from first dose of cetuximab to the date of death is observed. If subject has not died, the survival time will be censored on the last date the subject was known to be alive.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['induction chemotherapy', 'docetaxel', 'cisplatin', 'fluorouracil', 'cetuximab', 'intensity-modulated radiotherapy'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'referencesModule': {'references': [{'pmid': '170644', 'type': 'BACKGROUND', 'citation': 'Fu KK, Newman H, Phillips TL. Treatment of locally recurrent carcinoma of the nasopharynx. Radiology. 1975 Nov;117(2):425-31. doi: 10.1148/117.2.425.'}, {'pmid': '1555986', 'type': 'BACKGROUND', 'citation': 'Pryzant RM, Wendt CD, Delclos L, Peters LJ. Re-treatment of nasopharyngeal carcinoma in 53 patients. Int J Radiat Oncol Biol Phys. 1992;22(5):941-7. doi: 10.1016/0360-3016(92)90792-g.'}, {'pmid': '3597157', 'type': 'BACKGROUND', 'citation': 'Wang CC. Re-irradiation of recurrent nasopharyngeal carcinoma--treatment techniques and results. Int J Radiat Oncol Biol Phys. 1987 Jul;13(7):953-6. doi: 10.1016/0360-3016(87)90030-7.'}, {'pmid': '9531376', 'type': 'BACKGROUND', 'citation': 'Teo PM, Kwan WH, Chan AT, Lee WY, King WW, Mok CO. How successful is high-dose (> or = 60 Gy) reirradiation using mainly external beams in salvaging local failures of nasopharyngeal carcinoma? Int J Radiat Oncol Biol Phys. 1998 Mar 1;40(4):897-913. doi: 10.1016/s0360-3016(97)00854-7.'}, {'pmid': '11121630', 'type': 'BACKGROUND', 'citation': 'Leung TW, Tung SY, Sze WK, Sze WM, Wong VY, Wong CS, O SK. Salvage radiation therapy for locally recurrent nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1331-8. doi: 10.1016/s0360-3016(00)00776-8.'}, {'pmid': '15275714', 'type': 'BACKGROUND', 'citation': 'Poon D, Yap SP, Wong ZW, Cheung YB, Leong SS, Wee J, Tan T, Fong KW, Chua ET, Tan EH. Concurrent chemoradiotherapy in locoregionally recurrent nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2004 Aug 1;59(5):1312-8. doi: 10.1016/j.ijrobp.2004.01.037.'}, {'pmid': '6305129', 'type': 'BACKGROUND', 'citation': 'Yan JH, Hu YH, Gu XZ. Radiation therapy of recurrent nasopharyngeal carcinoma. Report on 219 patients. Acta Radiol Oncol. 1983;22(1):23-8. doi: 10.3109/02841868309134335.'}, {'pmid': '14967420', 'type': 'BACKGROUND', 'citation': 'Lu TX, Mai WY, Teh BS, Zhao C, Han F, Huang Y, Deng XW, Lu LX, Huang SM, Zeng ZF, Lin CG, Lu HH, Chiu JK, Carpenter LS, Grant WH 3rd, Woo SY, Cui NJ, Butler EB. Initial experience using intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):682-7. doi: 10.1016/S0360-3016(03)01508-6.'}, {'pmid': '16289398', 'type': 'BACKGROUND', 'citation': 'Chua DT, Sham JS, Leung LH, Au GK. Re-irradiation of nasopharyngeal carcinoma with intensity-modulated radiotherapy. Radiother Oncol. 2005 Dec;77(3):290-4. doi: 10.1016/j.radonc.2005.10.010. Epub 2005 Nov 8.'}, {'pmid': '16199985', 'type': 'BACKGROUND', 'citation': 'Chua DT, Sham JS, Au GK. Induction chemotherapy with cisplatin and gemcitabine followed by reirradiation for locally recurrent nasopharyngeal carcinoma. Am J Clin Oncol. 2005 Oct;28(5):464-71. doi: 10.1097/01.coc.0000180389.86104.68.'}, {'pmid': '17960012', 'type': 'BACKGROUND', 'citation': 'Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704. doi: 10.1056/NEJMoa071028.'}, {'pmid': '16467544', 'type': 'BACKGROUND', 'citation': 'Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. doi: 10.1056/NEJMoa053422.'}, {'pmid': '15234052', 'type': 'BACKGROUND', 'citation': 'Nakata E, Hunter N, Mason K, Fan Z, Ang KK, Milas L. C225 antiepidermal growth factor receptor antibody enhances the efficacy of docetaxel chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2004 Jul 15;59(4):1163-73. doi: 10.1016/j.ijrobp.2004.02.050.'}, {'pmid': '17960013', 'type': 'BACKGROUND', 'citation': 'Posner MR, Hershock DM, Blajman CR, Mickiewicz E, Winquist E, Gorbounova V, Tjulandin S, Shin DM, Cullen K, Ervin TJ, Murphy BA, Raez LE, Cohen RB, Spaulding M, Tishler RB, Roth B, Viroglio Rdel C, Venkatesan V, Romanov I, Agarwala S, Harter KW, Dugan M, Cmelak A, Markoe AM, Read PW, Steinbrenner L, Colevas AD, Norris CM Jr, Haddad RI; TAX 324 Study Group. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1705-15. doi: 10.1056/NEJMoa070956.'}]}, 'descriptionModule': {'briefSummary': 'Study Objective:\n\nPrimary\n\n1\\. To evaluate the complete response (CR) rate with induction chemotherapy using Docetaxel, Cisplatin and Fluorouracil(TPF) followed by Docetaxel plus Cetuximab (TC) in concurrence with intensity-modulated radiotherapy (IMRT).\n\nSecondary\n\n1. To determine the overall response rate.\n2. To determine the locoregional and distant control rate\n3. To determine the progression-free survival (PFS)\n4. To determine the overall survival (OS)\n5. To determine the safety of the induction chemotherapy and concurrent chemoradiation plus Cetuximab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Recurrent T3N0-N1M0 NPC (by AJCC/UICC 6th edition) and at least 1 year from the end of last primary course of radiotherapy\n* Age \\> 18 to \\< 70 years\n* Performance status: \\< 1 by ECOG System (Appendix I)\n* Adequate bone marrow \\& renal function\n* Patients having Bilirubin =\\< 1.5 x ULN, ASAT \\& ALST=\\< 1.5 x ULN, Serum creatinine=\\< 1.25 x ULN and / or Creatinine clearance \\>= 60ml/min\n* Patients having WBC \\>= 3x10e9/L, Neutrophils 1.8x10e9/L, Platelets \\>= 100 x10e9/L,Hemoglobin \\>=10g/dL\n* Signed written informed consent\n* Patients must have at least one measurable lesion\n\nExclusion Criteria:\n\n* Use of investigational agent within the past 28 days\n* Pre-treatment with an anti-EGFR drug\n* Severe cardiac disease such as heart failure, coronary artery disease or myocardial infarction within the last 12 months\n* History of severe pulmonary diseases\n* Active infection or other systemic disease under poor control\n* Uncontrolled chronic neuropathy\n* Know grade 3 or 4 allergic reaction to any of the components of the treatment\n* Estimated life expectancy is less than 3 months\n* Pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT01326559', 'briefTitle': 'Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil in Concurrence With Intensity-modulated Radiotherapy for Local Recurrent Nasopharyngeal Carcinoma (NPC)', 'organization': {'class': 'OTHER', 'fullName': 'Hong Kong Nasopharyngeal Cancer Study Group Limited'}, 'officialTitle': 'Phase II Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil Followed by Weekly Docetaxel and Cetuximab in Concurrence With Intensity-modulated Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma (NPC)', 'orgStudyIdInfo': {'id': 'NPC-1001 trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental 1', 'description': 'Induction chemotherapy using Docetaxel, Cisplatin and 5-FU for week 1 to week 9 and followed by concurrent chemoradiation plus cetuximab from week 10 to week 16', 'interventionNames': ['Drug: Docetaxel, Cisplatin, 5-FU and Cetuximab']}], 'interventions': [{'name': 'Docetaxel, Cisplatin, 5-FU and Cetuximab', 'type': 'DRUG', 'description': 'Induction phase (Weeks 1-9):\n\nDrug Docetaxel Docetaxel 75 mg/m2 IV, D1 every 3 weeks for 3 cycles\n\nDrug Cisplatin Cisplatin 75 mg/m2 IV, D1 every 3 weeks for 3 cycles\n\nDrug Fluorouracil Fluorouracil 750 mg/m2 IV, D1-4 every 3 weeks for 3 cycles\n\nConcurrent phase (weeks 10-16):\n\nDrug Docetaxel Docetaxel 15 mg/m2 IV, D1 weekly for 7 weeks (Weeks 10-16)\n\nDrug Cetuximab Cetuximab 400 mg m2 IV, D1 initial dose, then 250 mg/m2 weekly for 7 week (Weeks 10-16)\n\nIMRT (60 Gy to GTV or biological dose equivalent): 2 Gy/fraction/day, D1-5 per week, for 6 weeks (Weeks 11-16)', 'armGroupLabels': ['Experimental 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'Department of Clinical Oncology, Queen Mary Hospital(QMH), Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'China', 'facility': 'Department of Clinical Oncology, Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'China', 'facility': 'Department of Clinical Oncology, Tuen Mun Hospital (TMH), Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'China', 'facility': 'Department of Oncology, Princess Margaret Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Lee Anne W.M., F.R.C.R.(HK)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hong Kong Nasopharyngeal Cancer Study Group Limited', 'class': 'OTHER'}, 'collaborators': [{'name': 'The University of Hong Kong', 'class': 'OTHER'}, {'name': 'Sanofi', 'class': 'INDUSTRY'}, {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, {'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Service, Dept of Clinical Oncology, PYNEH', 'investigatorFullName': 'Dr. ANNE W M LEE', 'investigatorAffiliation': 'Hong Kong Nasopharyngeal Cancer Study Group Limited'}}}}