Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-04-24 @ 8:30 AM
Study NCT ID:
NCT02633202
Status:
UNKNOWN
Last Update Posted:
2018-12-13
First Post:
2015-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concurrent Chemotherapy for the Intermediate Risk Nasopharyngeal Carcinoma In Intensity-modulated Radiotherapy Era
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': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 338}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-11', 'studyFirstSubmitDate': '2015-12-03', 'studyFirstSubmitQcDate': '2015-12-14', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Failure-free survival', 'timeFrame': '3 Year', 'description': 'The failure-free survival rate will be estimated using the Kaplan-Meier method for each arm from the date of randomization to the date of treatment failure or death from any cause, whichever is first. Their differences will be compared between treatment arms using the log-rank test.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 Year', 'description': 'The overall survival rate will be estimated using the Kaplan-Meier method for each arm from randomization to death from any cause. Their differences will be compared between treatment arms using the log-rank test.'}, {'measure': 'Locoregional failure-free survival', 'timeFrame': '3 Year', 'description': 'The locoregional failure-free survival will be estimated using the Kaplan-Meier method for each arm from randomization to the first locoregional failure. Their differences will be compared between treatment arms using the log-rank test.'}, {'measure': 'Distant failure-free survival', 'timeFrame': '3 Year', 'description': 'The distant failure-free survival will be estimated using the Kaplan-Meier method for each arm from randomization to the first remote failure. Their differences will be compared between treatment arms using the log-rank test.'}, {'measure': 'Rates of participants with adverse events', 'timeFrame': '3 Year', 'description': "Acute and late toxicities will be documented according to the Common Terminology Criteria for Adverse Events version 3.0 and/or the Radiation Morbidity Scoring Criteria of the Radiation Therapy Oncology Group. Rates of the toxicities will be estimated using a binomial distribution along and will be compared using Fisher's exact test between the 2 treatment arms."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nasopharyngeal carcinoma', 'Concurrent chemoradiotherapy', 'intermediate risk', 'intensity-modulated radiotherapy'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'referencesModule': {'references': [{'pmid': '12833458', 'type': 'BACKGROUND', 'citation': 'Chua DT, Sham JS, Kwong DL, Au GK. Treatment outcome after radiotherapy alone for patients with Stage I-II nasopharyngeal carcinoma. Cancer. 2003 Jul 1;98(1):74-80. doi: 10.1002/cncr.11485.'}, {'pmid': '19231110', 'type': 'BACKGROUND', 'citation': 'Xiao WW, Han F, Lu TX, Chen CY, Huang Y, Zhao C. Treatment outcomes after radiotherapy alone for patients with early-stage nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2009 Jul 15;74(4):1070-6. doi: 10.1016/j.ijrobp.2008.09.008. Epub 2009 Feb 21.'}, {'pmid': '22056739', 'type': 'BACKGROUND', 'citation': 'Chen QY, Wen YF, Guo L, Liu H, Huang PY, Mo HY, Li NW, Xiang YQ, Luo DH, Qiu F, Sun R, Deng MQ, Chen MY, Hua YJ, Guo X, Cao KJ, Hong MH, Qian CN, Mai HQ. Concurrent chemoradiotherapy vs radiotherapy alone in stage II nasopharyngeal carcinoma: phase III randomized trial. J Natl Cancer Inst. 2011 Dec 7;103(23):1761-70. doi: 10.1093/jnci/djr432. Epub 2011 Nov 4.'}, {'pmid': '18216741', 'type': 'BACKGROUND', 'citation': 'Song CH, Wu HG, Heo DS, Kim KH, Sung MW, Park CI. Treatment outcomes for radiotherapy alone are comparable with neoadjuvant chemotherapy followed by radiotherapy in early-stage nasopharyngeal carcinoma. Laryngoscope. 2008 Apr;118(4):663-70. doi: 10.1097/MLG.0b013e3181626cfe.'}, {'pmid': '16750333', 'type': 'BACKGROUND', 'citation': 'Chua DT, Ma J, Sham JS, Mai HQ, Choy DT, Hong MH, Lu TX, Au GK, Min HQ. Improvement of survival after addition of induction chemotherapy to radiotherapy in patients with early-stage nasopharyngeal carcinoma: Subgroup analysis of two Phase III trials. Int J Radiat Oncol Biol Phys. 2006 Aug 1;65(5):1300-6. doi: 10.1016/j.ijrobp.2006.02.016. Epub 2006 Jun 5.'}, {'pmid': '21459659', 'type': 'BACKGROUND', 'citation': 'Xu T, Hu C, Wang X, Shen C. Role of chemoradiotherapy in intermediate prognosis nasopharyngeal carcinoma. Oral Oncol. 2011 May;47(5):408-13. doi: 10.1016/j.oraloncology.2011.03.008. Epub 2011 Apr 2.'}, {'pmid': '20643517', 'type': 'BACKGROUND', 'citation': 'Lai SZ, Li WF, Chen L, Luo W, Chen YY, Liu LZ, Sun Y, Lin AH, Liu MZ, Ma J. How does intensity-modulated radiotherapy versus conventional two-dimensional radiotherapy influence the treatment results in nasopharyngeal carcinoma patients? Int J Radiat Oncol Biol Phys. 2011 Jul 1;80(3):661-8. doi: 10.1016/j.ijrobp.2010.03.024. Epub 2010 Jul 17.'}, {'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': '24630534', 'type': 'BACKGROUND', 'citation': 'Lee AW, Ng WT, Chan LL, Hung WM, Chan CC, Sze HC, Chan OS, Chang AT, Yeung RM. Evolution of treatment for nasopharyngeal cancer--success and setback in the intensity-modulated radiotherapy era. Radiother Oncol. 2014 Mar;110(3):377-84. doi: 10.1016/j.radonc.2014.02.003. Epub 2014 Mar 11.'}, {'pmid': '21035959', 'type': 'BACKGROUND', 'citation': 'Su SF, Han F, Zhao C, Chen CY, Xiao WW, Li JX, Lu TX. Long-term outcomes of early-stage nasopharyngeal carcinoma patients treated with intensity-modulated radiotherapy alone. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):327-33. doi: 10.1016/j.ijrobp.2010.09.011. Epub 2010 Oct 29.'}, {'pmid': '20395788', 'type': 'BACKGROUND', 'citation': 'Tham IW, Lin S, Pan J, Han L, Lu JJ, Wee J. Intensity-modulated radiation therapy without concurrent chemotherapy for stage IIb nasopharyngeal cancer. Am J Clin Oncol. 2010 Jun;33(3):294-9. doi: 10.1097/COC.0b013e3181d2edab.'}, {'pmid': '23720240', 'type': 'BACKGROUND', 'citation': 'Luo S, Zhao L, Wang J, Xu M, Li J, Zhou B, Xiao F, Long X, Shi M. Clinical outcomes for early-stage nasopharyngeal carcinoma with predominantly WHO II histology treated by intensity-modulated radiation therapy with or without chemotherapy in nonendemic region of China. Head Neck. 2014 Jun;36(6):841-7. doi: 10.1002/hed.23386. Epub 2013 Oct 4.'}, {'pmid': '26611462', 'type': 'BACKGROUND', 'citation': 'Zhang F, Zhang Y, Li WF, Liu X, Guo R, Sun Y, Lin AH, Chen L, Ma J. Efficacy of Concurrent Chemotherapy for Intermediate Risk NPC in the Intensity-Modulated Radiotherapy Era: a Propensity-Matched Analysis. Sci Rep. 2015 Nov 27;5:17378. doi: 10.1038/srep17378.'}, {'pmid': '35997729', 'type': 'DERIVED', 'citation': 'Tang LL, Guo R, Zhang N, Deng B, Chen L, Cheng ZB, Huang J, Hu WH, Huang SH, Luo WJ, Liang JH, Zheng YM, Zhang F, Mao YP, Li WF, Zhou GQ, Liu X, Chen YP, Xu C, Lin L, Liu Q, Du XJ, Zhang Y, Sun Y, Ma J. Effect of Radiotherapy Alone vs Radiotherapy With Concurrent Chemoradiotherapy on Survival Without Disease Relapse in Patients With Low-risk Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA. 2022 Aug 23;328(8):728-736. doi: 10.1001/jama.2022.13997.'}]}, 'descriptionModule': {'briefSummary': 'Currently, concurrent chemoradiotherapy with/without sequential chemotherapy is the standard treatment modality for intermediate risk NPC (stage II and T3N0M0) according to the National Comprehensive Cancer Network guideline. However these recommendations were based on the evidence in the two-dimensional conventional radiotherapy (2DCRT) era. The introduction of intensity-modulated radiotherapy (IMRT) in NPC treatment has brought substantial better treatment outcomes than 2DCRT. It has been questioned whether additional concurrent chemotherapy is still necessary for intermediate risk NPC within the excellent framework of IMRT. Thus, the investigators jointly conduct the first non-inferior randomized trial to determine the value of concurrent chemotherapy with cisplatin for intermediate risk NPC patients treated with IMRT. Given the results of clinical studies mentioned above,the investigators decide to adopt the concurrent regimen to be cisplatin 100 mg/m2 on day 1, 22, 43', 'detailedDescription': 'Currently, concurrent chemoradiotherapy with/without sequential chemotherapy is the standard treatment modality for intermediate risk NPC (stage II and T3N0M0) according to the National Comprehensive Cancer Network guideline. However these recommendations were based on the evidence in the two-dimensional conventional radiotherapy (2DCRT) era. The introduction of intensity-modulated radiotherapy (IMRT) in NPC treatment has brought substantial better treatment outcomes than 2DCRT. It has been questioned whether additional concurrent chemotherapy is still necessary for intermediate risk NPC within the excellent framework of IMRT. Thus, the investigators jointly conduct the first non-inferior randomized trial to determine the value of concurrent chemotherapy with cisplatin for intermediate risk NPC patients treated with IMRT. Given the results of clinical studies mentioned above, the investigators decide to adopt the concurrent regimen to be cisplatin 100 mg/m2 on day 1, 22, 43'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type.\n* Tumor staged as T1-2N1/T2-3N0(according to the 7th AJCC edition).\n* No evidence of distant metastasis (M0).\n* Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.\n* Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 120g/L for male, ≥ 120g/L for female , and platelet count ≥ 100000/μL.\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* Adequate renal function: creatinine clearance ≥ 60 ml/min.\n* Patients must be informed of the investigational nature of this study and give written informed consent.\n\nExclusion Criteria:\n\n* Neck lymph node with extracapsular spread. Maximal axial diameter of neck lymph node ≥30mm, positive neck lymph node at level IV and/or Vb.\n* Pretreatment plasma EBV DNA level ≥4000 copy/ml.\n* WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.\n* Age \\> 65 or \\< 18.\n* Treatment with palliative intent.\n* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.\n* Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).\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': 'NCT02633202', 'briefTitle': 'Concurrent Chemotherapy for the Intermediate Risk Nasopharyngeal Carcinoma In Intensity-modulated Radiotherapy Era', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Prospective Non-inferior Clinical Trial Comparing Concurrent Chemoradiotherapy or Radiotherapy Alone in Patients With Intermediate Risk Nasopharyngeal Carcinoma in Intensity-modulated Radiotherapy Era', 'orgStudyIdInfo': {'id': 'IRNPC15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RT group', 'description': 'intensity modulated-radiotherapy (IMRT) alone: Patients receive intensity modulated-radiotherapy (IMRT) alone', 'interventionNames': ['Radiation: IMRT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CCRT group', 'description': 'IMRT and concurrent cisplatin Patients receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles', 'interventionNames': ['Radiation: IMRT', 'Drug: Cisplatin']}], 'interventions': [{'name': 'IMRT', 'type': 'RADIATION', 'otherNames': ['Intensity-modulated radiation therapy'], 'description': 'Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor', 'armGroupLabels': ['CCRT group', 'RT group']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['Concurrent cisplatin regimen'], 'description': 'concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles during IMRT', 'armGroupLabels': ['CCRT group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Chen, M.D.', 'role': 'CONTACT', 'email': 'chenlei@sysucc.org.cn', 'phone': '+86-20-87343096'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Lei Chen, M.D.', 'role': 'CONTACT', 'email': 'chenlei@sysucc.org.cn', 'phone': '+86-20-87343096'}], 'overallOfficials': [{'name': 'Lei Chen, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fifth Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': "First People's Hospital of Foshan", 'class': 'OTHER'}, {'name': 'Guilin Medical University, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Lei Chen', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}