Nctid:
NCT06235203
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002277", "term"=>"Carcinoma"}, {"id"=>"D000077274", "term"=>"Nasopharyngeal Carcinoma"}, {"id"=>"D000012008", "term"=>"Recurrence"}], "ancestors"=>[{"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"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"=>"M14850", "name"=>"Recurrence", "asFound"=>"Recurrent", "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"=>"M22700", "name"=>"Disease Attributes", "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"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}, {"name"=>"Ear, Nose, and Throat Diseases", "abbrev"=>"BC09"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000093542", "term"=>"Gemcitabine"}], "ancestors"=>[{"id"=>"D000000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000000963", "term"=>"Antimetabolites"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}], "browseLeaves"=>[{"id"=>"M2985", "name"=>"Gemcitabine", "asFound"=>"100", "relevance"=>"HIGH"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>154}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-05-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-06", "completionDateStruct"=>{"date"=>"2027-06-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-06-14", "studyFirstSubmitDate"=>"2023-12-21", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-06-17", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-06-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"EFS", "timeFrame"=>"From randomization and any events(like:progression or toxic effects precluding surgery;inability to resect all gross disease; progression;surgical complications precluding initiation of adjuvant therapy; recurrence;death) up to 1 year", "description"=>"Event free survival"}], "secondaryOutcomes"=>[{"measure"=>"OS", "timeFrame"=>"Time interval of randomization and death of any cause, up to 5 years", "description"=>"Overall Survival"}, {"measure"=>"DFS", "timeFrame"=>"From randomization to recurrence, metastasis or death, up to 1 year", "description"=>"Disease free survival"}, {"measure"=>"LRFS", "timeFrame"=>"From randomization to local recurrence or death, up to 1 year", "description"=>"Local recurrence free survival"}, {"measure"=>"DMFS", "timeFrame"=>"From randomization to distant metastasis or death, up to 1 year", "description"=>"Distant metastasis free survival"}, {"measure"=>"pCR", "timeFrame"=>"Time point of pathological tumor evaluation after sugery, around 2 weeks after sugery", "description"=>"pathologic complete response"}, {"measure"=>"ORR", "timeFrame"=>"Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year", "description"=>"Objective response rate,Proportion of CR, PR in all patients."}, {"measure"=>"DCR", "timeFrame"=>"Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year", "description"=>"Disease Control Rate,Proportion of CR, PR and SD in all patients."}, {"measure"=>"DoR", "timeFrame"=>"First date of response to the date of progression, up to 5 years", "description"=>"Duration of response,the time from the first assessment of the tumour as CR or PR to the first assessment of PD or death from any cause (whichever event occurs first)."}, {"measure"=>"1-and 2-year PFS rate", "timeFrame"=>"one- and two-year", "description"=>"one- and two-year progression free survival rate"}, {"measure"=>"1-and 2-year OS rate", "timeFrame"=>"one- and two-year", "description"=>"one- and two-year overall survival rate"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Recurrent Nasopharyngeal Carcinoma"]}, "descriptionModule"=>{"briefSummary"=>"A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy", "detailedDescription"=>"Eligible patients are randomized into the control group and the experimental group.\n\nPatients in the experimental group would be administrated 2 courses of neoadjuvant therapy before surgery.After endoscopic surgery, patients would continue to receive 2-4 courses of chemotherapy and 8 courses of immunotherapy.\n\nPatients in the control group would firstly receive endoscopic surgery, followed by chemotherapy and immunotherapy. In total, 4 to 6 courses of chemotherapy and 10 courses of immunotherapy would be administrated."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Pathologically diagnosed with recurrent nasopharyngeal carcinoma;\n2. Resectable disease staging rT2 (deep parapharyngeal space, or distance to the internal carotid ≤5mm) or rT3 (excluding the lesions confined to the basal wall of sphenoid sinus), rT4, according to AJCC 8th edition;\n3. Cervical lymph node metastasis can be controlled locally;\n4. Aged 18 to 70 years;\n5. Informed consent forms signed to participate in the trial;\n6. Without distant metastasis;\n7. ≥6months from the accomplishment of radical radiation to recurrence\n8. previously only 1 course of radiotherapy;\n9. Sufficient organ function;\n10. ECOG score 0-2 and can tolerate surgery,chemotherapy and immunotherapy.\n\nExclusion Criteria:\n\n1. Participate in other interventional clinical trials;\n2. Uncontrolled illnesses that interfere with the therapy;\n3. Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ, etc.);\n4. Any contradiction to surgery;\n5. With serious autoimmune disease;\n6. The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage\\>10mg/day prednisone or other glucocorticoids), and continues to use them within 2 weeks before the first administration;\n7. Severe allergic reactions to other monoclonal antibodies;\n8. Previously received treatment with PD-1 monoclonal antibody, PD-L1 monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway);\n9. History of radioactive particle planting;\n10. Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;\n11. Female patients who are at pregnancy or lactation;\n12. Other situations that the researchers believe not suitable for enrollment"}, "identificationModule"=>{"nctId"=>"NCT06235203", "briefTitle"=>"Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC", "organization"=>{"class"=>"OTHER", "fullName"=>"Eye & ENT Hospital of Fudan University"}, "officialTitle"=>"Neoadjuvant-Adjuvant Versus Adjuvant-Only Therapy Combined With Endoscopic Surgery in Advanced Recurrent Nasopharyngeal Carcinoma:A Multicenter Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"adv-rNPC-RCT-Neo-V1"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"The control group", "description"=>"Endoscopic surgery + adjuvant therapy", "interventionNames"=>["Procedure: endoscopic surgery", "Drug: Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy"]}, {"type"=>"EXPERIMENTAL", "label"=>"The experimental group", "description"=>"Neoadjuvant therapy +endoscopic surgery + adjuvant therapy", "interventionNames"=>["Procedure: endoscopic surgery", "Drug: Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy", "Drug: Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy"]}], "interventions"=>[{"name"=>"endoscopic surgery", "type"=>"PROCEDURE", "description"=>"The tumor was resected by endoscopic nasopharyngectomy.", "armGroupLabels"=>["The control group", "The experimental group"]}, {"name"=>"Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy", "type"=>"DRUG", "description"=>"Two courses of Toripalimab Injection and two courses of Toripalimab Injection and Gemcitabine based chemotherapy were given before endoscopic surgery.", "armGroupLabels"=>["The experimental group"]}, {"name"=>"Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy", "type"=>"DRUG", "description"=>"Eight courses of Toripalimab Injection and two to four courses of chemotherapy, or until unacceptable side effects.", "armGroupLabels"=>["The experimental group"]}, {"name"=>"Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy", "type"=>"DRUG", "description"=>"Ten courses of Toripalimab Injection and four to six courses of chemotherapy,or until unacceptable side effects.", "armGroupLabels"=>["The control group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"200031", "city"=>"Shanghai", "state"=>"Shanghai", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Xiaole Song", "role"=>"CONTACT", "email"=>"jxfxsxl@163.com", "phone"=>"15821388769"}, {"name"=>"Hongmeng Yu", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Xiaole Song", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Li Yan", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Yuting Lai", "role"=>"SUB_INVESTIGATOR"}], "facility"=>"Eye& ENT Hospital, Fudan University", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}, {"city"=>"Fuzhou", "status"=>"NOT_YET_RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Desheng Wang", "role"=>"CONTACT"}, {"name"=>"Desheng Wang", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Haichun Lai", "role"=>"SUB_INVESTIGATOR"}], "facility"=>"Fujian Medical University Union Hospital", "geoPoint"=>{"lat"=>26.06139, "lon"=>119.30611}}, {"city"=>"Nanning", "status"=>"NOT_YET_RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Shenhong Qu", "role"=>"CONTACT"}, {"name"=>"Shenhong Qu", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Jingjin Weng", "role"=>"SUB_INVESTIGATOR"}], "facility"=>"The People's Hospital of Guangxi Zhuang Autonomous Region", "geoPoint"=>{"lat"=>22.81667, "lon"=>108.31667}}, {"city"=>"Shanghai", "status"=>"NOT_YET_RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Haihong Tang", "role"=>"CONTACT"}, {"name"=>"Haihong Tang", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Hongliang Zheng", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Haopu Li", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Fengya Pan", "role"=>"SUB_INVESTIGATOR"}], "facility"=>"Changhai Hospital", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}, {"city"=>"Shanghai", "status"=>"NOT_YET_RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Weitian Zhang", "role"=>"CONTACT"}, {"name"=>"Weitian Zhang", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Ru Tang", "role"=>"SUB_INVESTIGATOR"}], "facility"=>"Shanghai Sixth People's Hospital", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}, {"city"=>"Shanghai", "status"=>"NOT_YET_RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Xinsheng Huang", "role"=>"CONTACT"}, {"name"=>"Xinsheng Huang", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Xianhui Ning", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Lei Zhou", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Shanghai Zhongshan Hospital", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}, {"city"=>"Shenzhen", "status"=>"NOT_YET_RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Yongtian Lu", "role"=>"CONTACT"}, {"name"=>"Yongtian Lu", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Jing Tao", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Shenzhen Second People's Hospital", "geoPoint"=>{"lat"=>22.54554, "lon"=>114.0683}}], "centralContacts"=>[{"name"=>"Xiaole Song", "role"=>"CONTACT", "email"=>"jxfxsxl@163.com", "phone"=>"+8621 64377134"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "ICF", "CSR"], "ipdSharing"=>"YES"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Eye & ENT Hospital of Fudan University", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Shanghai Zhongshan Hospital", "class"=>"OTHER"}, {"name"=>"Shanghai 6th People's Hospital", "class"=>"OTHER"}, {"name"=>"Changhai Hospital", "class"=>"OTHER"}, {"name"=>"Fujian Medical University Union Hospital", "class"=>"OTHER"}, {"name"=>"People's Hospital of Guangxi", "class"=>"OTHER"}, {"name"=>"Shenzhen Second People's Hospital", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}