Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-31 @ 8:06 PM
Study NCT ID:
NCT01689558
Status:
UNKNOWN
Last Update Posted:
2013-03-12
First Post:
2012-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recombine Endostatin With Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation in Advanced Nasopharynx Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009303', 'term': 'Nasopharyngeal 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': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-11', 'studyFirstSubmitDate': '2012-08-12', 'studyFirstSubmitQcDate': '2012-09-18', 'lastUpdatePostDateStruct': {'date': '2013-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'main objective', 'timeFrame': 'at the end of the Radiation', 'description': '1. observe and compare the curative effect of endostatin/recombined Endostatin in alliance with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to treat the local advanced nasopharyngeal darcinoma\n2. evaluate the security and tolerability in endostatin/recombined Endostatin in alliance with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to treat the local advanced nasopharyngeal darcinoma.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['nasopharynx cancer,Image department of nose pharynx ministry'], 'conditions': ['1、Enough Cases', '2、Elekta Precise 1343 Digital Control Electron Linear Accelerator', 'Can Undertake Nasopharyngeal Carcinoma Specimens in the Materia，', 'Image Department of Nose Pharynx Ministry MRI Dynamic Testing,']}, 'descriptionModule': {'briefSummary': '1\\) Observe and compare the curative effect of endostatin/recombined Endostatin in alliance with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to treat the local advanced nasopharyngeal darcinoma; 2) Evaluate the security and tolerability in endostatin/recombined Endostatin in alliance with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to treat the local advanced nasopharyngeal darcinoma.', 'detailedDescription': '1. experimental group:docetaxel 75mg/m2 iv in day 1 +Cisplatin 80mg/m2 iv in day 1 +human endostatin 7.5mg/m2 iv in day 8-21 and three weeks repeat and total two cycles;followed by concurrent chemoradiation(Cisplatin 80mg/m2 iv in day 1,21 +human endostatin 7.5mg/m2 iv in day 1-14 and Concurrent Intensity-modulated radiation therapy)\n2. Control group:group:docetaxel 75mg/m2 iv in day 1 +Cisplatin 80mg/m2 iv in day 1 and three weeks repeat and total two cycles;followed by concurrent chemoradiation(Cisplatin 80mg/m2 iv in day 1,21 and Concurrent Intensity-modulated radiation therapy)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Voluntary and sign the informed consent form; 2) Age 18-70 years old, male or female; 3) histologically proved to be keratinizing carcinoma or non-keratinizing carcinoma; 4) nasopharyngeal darcinoma 2010 UICC staging III-IV A, IV B; 5) measurable Primary tumors; 6) karnofsky score≥70; ECOG≥2; 7) Expected survival≥6 months; 8) Women in productive age should guarantee use contraceptives during study period; 9) Hemoglobin(HGB) ≥100g/L, white blood cell(WBC) ≥4×109 /L，Platelet（PLT）≥100×109 /L.（or white blood cell and platelet not less than our hospital's Normal lowest index）; 10) liver function: Alanine amino transferase (ALAT), aspartate aminotransferase (ASAT) \\<1.5 times the upper limit of the normal index; total bilirubin\\<1.5×ULN; 11) liver function: serum creatinine\\<1.5×ULN; 12) do not have severe complication, such as Hypertensio, Diabetes and History of mental illness; 13) this treatment is First treatment process (do not have a H\\&N Radiation history; do not have a history of Concurrent chemoradiotherapy; do not have chemotherapy history in 3 months.\n\nExclusion Criteria:\n\n1. Have a distant metastasis; 2) The primary focal tumors or lymph node already had a surgical treatment (except for biopsy); 3) Already had a radiotherapy for primary focal or lymph node; 4) Patient who received the the epidermal growth factor targeted therapy; 5) The primary focal had received chemoradiotherapy or immunotherapy; 6) Patient who suffered from other malignant tumor (except for cured basal cell carcinoma or carcinoma in situ of cervix); 7) Subject who have taken other drug test in 1 month; 8) Peripheral Neuropathy\\> level; 9) pregnant woman or Lactating Women and Women in productive age who refuse take contraception in observation period; 10) subject with a severe allergic history or idiosyncratic; 11) subject with severe pulmonary and cardiopathic disease history; 12) refuse or incapable to sign the informed consent form of participating this trial; 13) drug abuse or alcohol addicted; 14) subject with a Personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct."}, 'identificationModule': {'nctId': 'NCT01689558', 'briefTitle': 'Recombine Endostatin With Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation in Advanced Nasopharynx Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Hospital of Guizhou Province'}, 'officialTitle': 'Recombine Endostatin in Alliance With Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': '20111220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Recombine Endostatin', 'description': 'Induction chemotherapy:docetaxel 75mg/m2 iv in day 1 +Cisplatin 80mg/m2 iv in day 1 +human endostatin 7.5mg/m2 iv in day 8-21 and three weeks repeat and total two cycles Synchronous chemotherapy: cisplatin 80 mg/m2 points d1-2, 21days for a cycle, 2 cycles, the same day in radiation therapy. Synchronous chemotherapy in chemotherapy day one recombinant human vascular endothelial inhibin 7.5 mg/M2 / d, 1-14 days, a total of one period of treatment', 'interventionNames': ['Drug: Recombine Endostatin']}], 'interventions': [{'name': 'Recombine Endostatin', 'type': 'DRUG', 'otherNames': ['recombinant human vascular endothelial inhibin'], 'description': 'Recombine Endostatin is involved in the arm of Recombine Endostatin .Recombinant human vascular endothelial inhibin 7.5 mg/M2 / d dose add 250 ml of physiological saline, dilute in new adjuvant chemotherapy began to 8-21 days intravenous drip, at least 1 hour, a total of 1 cycle; The chemoradiation in cisplatin chemotherapy first day grace degrees 7.5 mg/M2 / d, 1-14 days, a total of one period of treatment', 'armGroupLabels': ['Recombine Endostatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '550002', 'city': 'Guiyang', 'state': 'Guizhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Jin, Professor', 'role': 'CONTACT', 'email': 'jinf8865@gmail.com', 'phone': '+86 13985124806'}, {'name': 'Feng Jin, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Hospital of Guizhou province', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}], 'centralContacts': [{'name': 'Feng Jin, Professor', 'role': 'CONTACT', 'email': 'jinf8865@gmail.com', 'phone': '+86 13985124806'}], 'overallOfficials': [{'name': 'Jin Feng, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Hospital of Guizhou Province'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jin Feng', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin Feng', 'investigatorAffiliation': 'Cancer Hospital of Guizhou Province'}}}}