[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100399216":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":92,"centralContacts":96,"locations":106,"responsibleParty":127,"collaborators":129,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":49,"eligibilityCriteria":138,"healthyVolunteers":134,"sex":139,"minAge":49,"maxAge":140,"enrollmentInfo":141,"targetDuration":49,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":108,"whyStopped":49,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Shanghai Children's Medical Center","OTHER",[8,15,23,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","* Group A1： tumor is completely resected at diagnosis and receives no adjuvant chemotherapy（well differentiated fetal \\[WDF\\] histology HB) ；\n* Group A2：tumor is completely resected followed by 2 cycles of standard dose cisplatin monotherapy （non-well differentiated fetal histology HB)",[13,14],"Procedure: Primary surgery resection","Drug: mono CDDP-Group A2",{"label":16,"type":10,"description":17,"interventionNames":18},"Group B","* Patients will be randomized to one of 2 arms: Arm CDDP or Arm CDDP plus STS. In each arm, patients will be stratified by resectablity after completion of 2 cycles of protocol therapy (6 cycles of standard dose cisplatin monotherapy with or without STS). All the patients in 2 arms will receive 6 cycles chemotherapy in total.\n* Resection of the primary tumor will be performed after completing the 2nd cycle of chemotherapy.\n* Those patients whose tumors after 2 cycles do not meet criteria for definitive surgical, 2nd resectablity evaluation will be scheduled after 4 cycles of chemotherapy.",[19,20,21,22],"Drug: Sodium Thiosulfate Injection","Procedure: Biopsy","Procedure: Resection or transplant","Drug: mono CDDP- Group B",{"label":24,"type":10,"description":25,"interventionNames":26},"Group C","* Patients in Group C will have locally advanced tumors including PRETEXT I-III tumors with a positive VPEFR annotation factor and all PRETEXT IV tumors.\n* Patients will be randomized to one of 2 arms: Arm C5VD or Arm C5VD plus STS. In each arm, patients will be stratified by resectablity after completion of 2 cycles of protocol therapy. All the patients in 2 arms will receive 6 cycles chemotherapy in total.\n* Resection of the primary tumor will be performed after completing the 2nd cycle of chemotherapy.\n* Those patients whose tumors after 2 cycles do not meet criteria for definitive surgical, 2nd resectablity evaluation will be scheduled after 4 cycles of chemotherapy.",[19,27,20,21],"Drug: Cisplatin, 5-Fluorouracil, Vincristine, Doxorubicin-Group C",{"label":29,"type":10,"description":30,"interventionNames":31},"Group D","* These patients have metastatic disease, suspected HB patients ≥ 8 years of age, or have an AFP ≤ 100 at diagnosis.\n* Patients will receive initial chemotherapy according to the cisplatin-intensive SIOPEL-4 induction regimen. Resection (including transplant) of the primary tumor should be completed after induction Block 3, but primary tumor resection can be planned any time after completing induction therapy.\n* Following 3 blocks of induction chemotherapy, patients will be stratified into 2 risk groups: Group D1 includes patients who either have a chemotherapy-induced lung CR or are rendered a lung CR by surgical metastasectomy. These patients will have chemotherapy consolidation with carboplatin\u002Fdoxorubicin. In Group D2, patients will have not yet achieved a lung CR at the end of induction Block 3. These patients will get intensified consolidation therapy of carboplatin\u002Fdoxorubicin with vincristine\u002Firinotecan.\n* Resection of pulmonary nodules should be considered in Group D2.",[20,21,32,33,34,35],"Procedure: Resection of pulmonary nodules","Drug: Block 1 to 3 (Cisplatin, Doxorubicin) Group D","Drug: Consolidation (Carboplatin, Doxorubicin) -Group D1","Drug: Consolidation (Carboplatin +Doxorubicin\u002FVincristine + Irinotecan)-Group D2",[37,44,50,54,60,64,68,72,76,80,86],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","Sodium Thiosulfate Injection","Weight ≥ 10 kg: 20 g\u002Fm2\u002Fdose STS or Weight 5-10 kg: 15 g\u002Fm2\u002Fdose STS or Weight \\\u003C 5 kg: 10 g\u002Fm2\u002Fdose STS will be administered by IV over 2 hours beginning 6 hours after the completion of each cisplatin infusion.",[16,24],[43],"STS",{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"PROCEDURE","Primary surgery resection","Resection of the primary tumor up-front",[9],null,{"type":38,"name":51,"description":52,"armGroupLabels":53,"otherNames":49},"mono CDDP-Group A2","Cisplatin 100 mg\u002Fm2\u002Fdose Day 1 . All non-WDF patients (A2) will receive 2 cycles of mono cisplatin (100 mg\u002Fm2\u002Fdose) chemotherapy. Each cycle lasts 3 weeks (21 days).",[9],{"type":38,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Cisplatin, 5-Fluorouracil, Vincristine, Doxorubicin-Group C","All the patients in Group C (2 arms) will receive 6 cycles chemotherapy in total. Cisplatin 100 mg\u002Fm2\u002Fdose Day 1; 5-Fluorouracil 600 mg\u002Fm2\u002Fdose Day 1; Vincristine 1.5 mg\u002Fm2\u002Fdose Day 1,8 and 15; Doxorubicin 30 mg\u002Fm2\u002Fdose Day 1 and 2; (Dexrazoxane : 300 mg\u002Fm2\u002Fdose Day 1 and 2, where is available)",[24],[59],"C5VD Group C",{"type":45,"name":61,"description":62,"armGroupLabels":63,"otherNames":49},"Biopsy","Tumors are deemed unresectable at diagnosis.",[16,24,29],{"type":45,"name":65,"description":66,"armGroupLabels":67,"otherNames":49},"Resection or transplant","Ideal timing to resect of the primary tumors or transplant if if excellent response achieved at 1st or 2nd evaluation timepoint. But surgery timing is not mandated. Irrespective of the timing of surgery, patients should complete all planned protocol cycles of chemotherapy (including post transplantation). If surgical resection of the primary tumor is delayed until the end of therapy, no further post-operative chemotherapy should be given.",[16,24,29],{"type":45,"name":69,"description":70,"armGroupLabels":71,"otherNames":49},"Resection of pulmonary nodules","Resection of pulmonary nodules should be considered in Group D2, patients at any cycle if continuing to respond to consolidation therapy.",[29],{"type":38,"name":73,"description":74,"armGroupLabels":75,"otherNames":49},"mono CDDP- Group B","Cisplatin 80 mg\u002Fm2\u002Fdose Day 1. All patients in Group B (2 arms) will receive 6 cycles of mono cisplatin chemotherapy. Each cycle lasts 2 weeks (14 days).",[16],{"type":38,"name":77,"description":78,"armGroupLabels":79,"otherNames":49},"Block 1 to 3 (Cisplatin, Doxorubicin) Group D","Block 1 and 2: Cisplatin 70 mg\u002Fm2\u002Fdose Day1, 8 and 15; Doxorubicin 30 mg\u002Fm2\u002Fdose, Day 8 and 9; (Dexrazoxane: 300 mg\u002Fm2\u002Fdose Day 1 and 2, where is available); Block 3: Cisplatin 70 mg\u002Fm2\u002Fdose Day1and 8; Doxorubicin 30 mg\u002Fm2\u002Fdose Day 8 and 9; (Dexrazoxane BSA ≥ 0.6 m2\u002Fdose: 300 mg\u002Fm2\u002Fdose Day 8 and 9, where is available) All patients in Group D will receive 3 blocks in induction, followed by consolidation therapy. Block 1 and 2 last 28 days. Block 3 is 21 cycles.",[29],{"type":38,"name":81,"description":82,"armGroupLabels":83,"otherNames":84},"Consolidation (Carboplatin, Doxorubicin) -Group D1","Following Block 1-3 of induction therapy, Group D1 patients will receive 3 cycles of Carboplatin + Doxorubicin consolidation therapy. Each cycle lasts 3 weeks (21 days). Carboplatin 500 mg\u002Fm2\u002Fdose Day 1; Doxorubicin 20 mg\u002Fm2\u002Fdose Day 1 and 2; (Dexrazoxane: 200 mg\u002Fm2\u002Fdose Day 1 and 2, where is available).",[29],[85],"Group D1 CD",{"type":38,"name":87,"description":88,"armGroupLabels":89,"otherNames":90},"Consolidation (Carboplatin +Doxorubicin\u002FVincristine + Irinotecan)-Group D2","Following Block 1-3 of induction therapy, patients in Group D2, will receive 6 cycles of consolidation chemotherapy with Carboplatin + Doxorubicin in Cycles 1, 3, and 5 alternating with Vincristine + irinotecan in Cycles 2, 4, and 6. One cycle of therapy lasts 3 weeks (21 days). Cycle 1, 3 and 5: Carboplatin 500 mg\u002Fm2\u002Fdose Day 1; Doxorubicin 20 mg\u002Fm2\u002Fdose Day 1 and 2; (Dexrazoxane: 200 mg\u002Fm2\u002Fdose Day 1 and 2, where is available).\n\nCycle 2, 4 and 6: Vincristine 1.5 mg\u002Fm2\u002Fdose, Day 1 and 8; Irinotecan 50 mg\u002Fm2\u002Fdose, Day 1 to 5;",[29],[91],"Group D2 CD\u002FVI",[93],{"name":94,"affiliation":5,"role":95},"Yi-Jin Gao, MD","PRINCIPAL_INVESTIGATOR",[97,102],{"name":98,"role":99,"phone":100,"phoneExt":49,"email":101},"Haishan Ruan, MS","CONTACT","+8618801902467","ruanhaishan@scmc.com.cn",{"name":103,"role":99,"phone":104,"phoneExt":49,"email":105},"Yujia Tang, MD","+8618516342079","tangyuejia@scmc.com.cn",[107],{"facility":5,"status":108,"city":109,"state":110,"zip":111,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":119,"contacts":120},"RECRUITING","Shanghai","Shanghai Municipality","200127","China","CN",{"type":115,"coordinates":116},"Point",[117,118],121.45806,31.22222,{"lat":118,"lon":117},[121,125],{"name":122,"role":99,"phone":123,"phoneExt":49,"email":124},"Hongxiang Gao, M.D.","+8615216606578","gaohongxiang@scmc.com.cn",{"name":126,"role":95,"phone":49,"phoneExt":49,"email":49},"YiJin Gao, Ph.D.",{"type":128,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR",[130],{"name":131,"class":6},"Shanghai Children's Hospital","100399216","phase-3-a-multi-institutional-study-for-treatment-of-children-with-newly-diagnosed-hepatoblastoma-using-a-modified-phitt-strategy-100399216",false,"NCT04478292","A Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy","A Phase 3 Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy Incorporating a Randomized Assessment of Sodium Thiosulfate as Otoprotection for Children With Localized Disease, and Response Adapted Therapy for Patients With Metastatic Disease","Inclusion Criteria:\n\n* Performance Level Patients must have a performance status corresponding to ECOG scores 0, 1, or 2. Use Karnofsky for patients \\>16 years of age and Lansky for patients ≤16 years of age.\n* Diagnosis Patients must be newly diagnosed with histologically-proven primary pediatric HB\n* Emergent Treatment for HB In emergency situation when a patient meets all other eligibility criteria and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy.\n* Prior Therapy Patients may have had surgical resection of the hepatic malignancy prior to enrollment. All other anti-cancer therapy for the current liver lesion is prohibited.\n* Organ Function Requirements\n\nI) Adequate renal function defined as:\n\nCreatinine clearance or radioisotope Glomerular Filtration Rate (GFR) ≥ 70 mL\u002Fmin\u002F1.73 m2\n\nII) Adequate liver function defined as:\n\nTotal bilirubin ≤ 5 x upper limit of normal (ULN) for age, and Aspartate aminotransferase (AST) or Alanine transaminase (ALT) \\\u003C 10 x upper limit of normal (ULN) for age.\n\nIII) Adequate pulmonary function defined as:\n\nNormal pulmonary function tests (including DLCO) if there is clinical indication for determination (e.g. dyspnea at rest, known requirement for supplemental oxygen)\n\nExclusion Criteria:\n\n* Prior chemotherapy or tumor directed therapy expect for surgical resection of the hepatic malignancy (i.e. radiation therapy, biologic agents, local therapy (embolization, radiofrequency ablation, and laser)). Therefore, patients with a pre-disposition syndrome who have a prior malignancy are not eligible.\n* Patients who are currently receiving another investigational drug.\n* Patients who are currently receiving other anticancer agents.\n* Patients with uncontrolled infection.\n* Patients who previously received a solid organ transplant.","ALL","18 Years",{"count":142,"type":143},330,"ESTIMATED","INTERVENTIONAL",[146],"PHASE3","A Phase 3 multi-institutional study for treatment of children with newly diagnosed hepatoblastoma using a modified Paediatric Hepatic International Tumour Trial (PHITT) strategy incorporating a randomized assessment of sodium thiosulfate as auditory protection for children with localized disease, and response adapted therapy for patients with metastatic disease",[149],"Hepatoblastoma",[151],"hepatoblastoma, sodium thiosulfate, auditory protection","2026-04-28",{"date":154,"type":155},"2026-05-04","ACTUAL",{"date":157,"type":155},"2021-03-01",{"date":159,"type":143},"2027-09-30",{"name":5,"class":6},1]