Nctid:
NCT06611150
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002277", "term"=>"Carcinoma"}, {"id"=>"D000077274", "term"=>"Nasopharyngeal Carcinoma"}], "ancestors"=>[{"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000009303", "term"=>"Nasopharyngeal Neoplasms"}, {"id"=>"D000010610", "term"=>"Pharyngeal Neoplasms"}, {"id"=>"D000010039", "term"=>"Otorhinolaryngologic Neoplasms"}, {"id"=>"D000006258", "term"=>"Head and Neck Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009302", "term"=>"Nasopharyngeal Diseases"}, {"id"=>"D000010608", "term"=>"Pharyngeal Diseases"}, {"id"=>"D000009057", "term"=>"Stomatognathic Diseases"}, {"id"=>"D000010038", "term"=>"Otorhinolaryngologic Diseases"}], "browseLeaves"=>[{"id"=>"M5534", "name"=>"Carcinoma", "asFound"=>"Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M1730", "name"=>"Nasopharyngeal Carcinoma", "asFound"=>"Nasopharyngeal Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M12254", "name"=>"Nasopharyngeal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M13517", "name"=>"Pharyngeal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M12962", "name"=>"Otorhinolaryngologic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M9348", "name"=>"Head and Neck Neoplasms", "relevance"=>"LOW"}, {"id"=>"M12253", "name"=>"Nasopharyngeal Diseases", "relevance"=>"LOW"}, {"id"=>"M13515", "name"=>"Pharyngeal Diseases", "relevance"=>"LOW"}, {"id"=>"M12017", "name"=>"Stomatognathic Diseases", "relevance"=>"LOW"}, {"id"=>"M12961", "name"=>"Otorhinolaryngologic Diseases", "relevance"=>"LOW"}, {"id"=>"T4047", "name"=>"Nasopharyngeal Carcinoma", "asFound"=>"Nasopharyngeal Carcinoma", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}, {"name"=>"Ear, Nose, and Throat Diseases", "abbrev"=>"BC09"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000017239", "term"=>"Paclitaxel"}], "ancestors"=>[{"id"=>"D000000972", "term"=>"Antineoplastic Agents, Phytogenic"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000050257", "term"=>"Tubulin Modulators"}, {"id"=>"D000050256", "term"=>"Antimitotic Agents"}, {"id"=>"D000050258", "term"=>"Mitosis Modulators"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M19537", "name"=>"Paclitaxel", "asFound"=>"Surgery", "relevance"=>"HIGH"}, {"id"=>"M231", "name"=>"Albumin-Bound Paclitaxel", "relevance"=>"LOW"}, {"id"=>"M26197", "name"=>"Tubulin Modulators", "relevance"=>"LOW"}, {"id"=>"M26196", "name"=>"Antimitotic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>24}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-08-02", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2027-08-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-08-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"The maximum tolerated dose and the recommended phase II dose", "timeFrame"=>"From start of radiotherapy to 2 weeks after completion of radiotherapy", "description"=>"The maximum tolerated dose and the recommended phase II dose for nab-paclitaxel when administered concurrently with radiotherapy."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["nasopharyngeal carcinoma", "nab-paclitaxel", "concurrent chemotherapy"], "conditions"=>["Nasopharyngeal Carcinoma (NPC)"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to determine the maximum tolerated dose and the recommended phase II dose for nab-paclitaxel when administered concurrently with radiotherapy in nasopharyngeal carcinoma. Researchers will observe the toxicity response of patients receiving nab-paclitaxel at 180 mg/m², 200 mg/m², 230 mg/m², and 260 mg/m²."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Pathologically confirmed nasopharyngeal carcinoma\n* III-IVa (AJCC8th)\n* age 18-70\n* PS score 0-1\n* normal functions to tolerate chemotherapy and radiotherapy\n\nExclusion Criteria:\n\n* The presence of other malignant neoplasms within the preceding five years, with the exception of carcinoma in situ, adequately treated non-melanoma skin cancer and papillary thyroid cancer, is permitted.\n* Symptomatic heart failure, unstable angina, myocardial infarction, active infections requiring systemic therapy, psychiatric disorders, or family and social factors"}, "identificationModule"=>{"nctId"=>"NCT06611150", "briefTitle"=>"Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma", "organization"=>{"class"=>"OTHER", "fullName"=>"Sun Yat-sen University"}, "officialTitle"=>"A Phase I Study of Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma", "orgStudyIdInfo"=>{"id"=>"B2024-076-01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"nab-paclitaxel arm", "description"=>"All patients enrolled in the study will be treated with nab-paclitaxel during radical radiotherapy following induction chemotherapy. The doses are increased progressively from 180 mg/m² to a maximum of 260 mg/m².", "interventionNames"=>["Drug: Nab-paclitaxel"]}], "interventions"=>[{"name"=>"Nab-paclitaxel", "type"=>"DRUG", "description"=>"All participants enrolled in the study will be treated with nab-paclitaxel during radical radiotherapy following induction chemotherapy. The doses are increased progressively (180 mg/m², 200 mg/m², 230 mg/m², and 260 mg/m²).", "armGroupLabels"=>["nab-paclitaxel arm"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"510060", "city"=>"Guangzhou", "state"=>"Guangdong", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Fang-Yun Xie", "role"=>"CONTACT", "email"=>"xiefy@sysucc.org.cn", "phone"=>"+8613902205880"}, {"name"=>"Pu-Yun OuYang", "role"=>"CONTACT", "email"=>"ouyangpy@sysucc.org.cn"}, {"name"=>"Fang-Yun Xie", "role"=>"CONTACT"}], "facility"=>"Sun Yat-sen University Cancer Center", "geoPoint"=>{"lat"=>23.11667, "lon"=>113.25}}], "centralContacts"=>[{"name"=>"Fang-Yun Xie", "role"=>"CONTACT", "email"=>"xiefy@sysucc.org.cn", "phone"=>"+8613902205880"}, {"name"=>"Pu-Yun OuYang", "role"=>"CONTACT", "email"=>"ouyangpy@sysucc.org.cn"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Sun Yat-sen University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"professor", "investigatorFullName"=>"Fang-Yun Xie", "investigatorAffiliation"=>"Sun Yat-sen University"}}}}
