Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT03558035
Status:
UNKNOWN
Last Update Posted:
2021-01-29
First Post:
2018-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007012', 'term': 'Hypopharyngeal Neoplasms'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2018-06-05', 'studyFirstSubmitQcDate': '2018-06-05', 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '5 year'}], 'secondaryOutcomes': [{'measure': 'disease free survival', 'timeFrame': '5 year'}, {'measure': 'distant-metastasis free survival', 'timeFrame': '5 year'}, {'measure': 'larynx-preservation rate', 'timeFrame': '5 year'}, {'measure': 'treatment related toxicities', 'timeFrame': '2 year', 'description': 'hematology and surgery related complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypopharyngeal carcinoma', 'Locally advanced', 'Multi-disciplinary treatment', 'Functional Magnetic Resonance Imaging', 'Prognosis'], 'conditions': ['Hypopharyngeal Cancer']}, 'referencesModule': {'references': [{'pmid': '21684027', 'type': 'BACKGROUND', 'citation': 'Blanchard P, Baujat B, Holostenco V, Bourredjem A, Baey C, Bourhis J, Pignon JP; MACH-CH Collaborative group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): a comprehensive analysis by tumour site. Radiother Oncol. 2011 Jul;100(1):33-40. doi: 10.1016/j.radonc.2011.05.036. Epub 2011 Jun 16.'}, {'pmid': '23835714', 'type': 'BACKGROUND', 'citation': 'Blanchard P, Bourhis J, Lacas B, Posner MR, Vermorken JB, Cruz Hernandez JJ, Bourredjem A, Calais G, Paccagnella A, Hitt R, Pignon JP; Meta-Analysis of Chemotherapy in Head and Neck Cancer, Induction Project, Collaborative Group. Taxane-cisplatin-fluorouracil as induction chemotherapy in locally advanced head and neck cancers: an individual patient data meta-analysis of the meta-analysis of chemotherapy in head and neck cancer group. J Clin Oncol. 2013 Aug 10;31(23):2854-60. doi: 10.1200/JCO.2012.47.7802. Epub 2013 Jul 8.'}, {'pmid': '19318632', 'type': 'BACKGROUND', 'citation': 'Pointreau Y, Garaud P, Chapet S, Sire C, Tuchais C, Tortochaux J, Faivre S, Guerrif S, Alfonsi M, Calais G. Randomized trial of induction chemotherapy with cisplatin and 5-fluorouracil with or without docetaxel for larynx preservation. J Natl Cancer Inst. 2009 Apr 1;101(7):498-506. doi: 10.1093/jnci/djp007. Epub 2009 Mar 24.'}, {'pmid': '36447152', 'type': 'DERIVED', 'citation': 'Luo X, Huang X, Luo J, Xiao J, Wang K, Qu Y, Chen X, Zhang Y, Wu R, Wang J, Zhang J, Xu G, Gao L, Liu S, Wang X, He X, Luo D, Yi J. Induction TPF followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locally advanced hypopharyngeal cancer: a preliminary analysis of a randomized phase 2 trial. BMC Cancer. 2022 Nov 29;22(1):1235. doi: 10.1186/s12885-022-10306-y.'}]}, 'descriptionModule': {'briefSummary': 'To develope stratification treatment for the patients who have locally advanced hypopharyngeal carcinoma. Experimental group patients were treated individually according to the response status after induction chemotherapy, receiving chemoradiotherapy or surgery. Thus to achieve a better survival rate and a higher larynx-preservation rate as well as a lower treatment related toxicity rate compared with standard treatment.', 'detailedDescription': 'Eligiblity patient were assign to induction chemotherapy plus concurrent chemotherapy group (IC +CCRT group, Arm A)and concurrent chemoradiotherapy group(CCRT group, Arm B). For patients in Arm A, treatment response were evaluated after 2cycles, if the response reached partial response/complete response, patients received concurrent chemoradiotherapy, otherwise, patients will received surgery and radiotherpay/concurrent chemoradiotherapy after surgery. For patients received concurrent chemoradiotherapy (both in Arm A and Arm B) , treatment response were evaluated at 50 Gy. if response reached complete response or major partial response(\\>80% tumor regression), patients will received radical chemoradiotherapy, otherwise, patients will received surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven squamous cell carcinoma of hypopharynx\n* Stage III/IV M0, with T3/4 N0-3 or T1-4 N2-3\n* Karnofsky Performance Status\\>=70\n* Have measurable lesions on CT/MRI\n* Treatment for the first time\n* Expected lifetime \\> 6 months\n* Normal blood test, hepatic and renal functions\n* Normal hearing\n* Can understand and sign the consent\n* Have follow up condition\n\nExclusion Criteria:\n\n* Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)\n* Previously treatment for cancer\n* Pregnant or breeding woman, female without contraception\n* Enrolling in other drug trials\n* Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes\n* Without follow up\n* Receive target therapy'}, 'identificationModule': {'nctId': 'NCT03558035', 'briefTitle': 'New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'LC2014L12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Induction chemotherapy and concurret chemoradiotherapy group', 'description': 'Patients receive 2 cycles of paclitaxel, cisplatin and 5-Fluorouracil chemotherapy followed by Surgery or Chemo-radiotherapy according to the response status after induction chemo.', 'interventionNames': ['Drug: Induction CT+ CRT group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Concurrent chemoradiotherapy group', 'description': 'Patients receive single-agent cisplatin chemotherapy concurrent with Radiotherapy', 'interventionNames': ['Radiation: Concurrent CRT group']}], 'interventions': [{'name': 'Induction CT+ CRT group', 'type': 'DRUG', 'description': 'Induction CT: Paclitaxel 175mg/m2 IV on d1 and d22, cisplatin 75mg/m2 IV on d1 and d22, 5-Fluorouracil 750mg/m2 IV continuously on d1-4 and d22-25, CRT: cisplatin 80mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy', 'armGroupLabels': ['Induction chemotherapy and concurret chemoradiotherapy group']}, {'name': 'Concurrent CRT group', 'type': 'RADIATION', 'description': 'cisplatin 100mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy', 'armGroupLabels': ['Concurrent chemoradiotherapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junlin YI, MD', 'role': 'CONTACT', 'email': 'junlinyi@sohu.com', 'phone': '861087788504'}], 'facility': 'Cancer hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Junlin Yi, Professor', 'role': 'CONTACT', 'email': 'yijunlin1969@163.com', 'phone': '0086013661217998'}], 'overallOfficials': [{'name': 'Junlin Yi, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CAMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jun-Lin Yi, MD', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}