Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-08 @ 1:14 AM
Study NCT ID:
NCT03360760
Status:
UNKNOWN
Last Update Posted:
2018-08-28
First Post:
2017-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Timing of Surgery in Nonmetastatic Osteosarcoma of the Pelvis and Sacrum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012516', 'term': 'Osteosarcoma'}], 'ancestors': [{'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}], 'ancestors': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-25', 'studyFirstSubmitDate': '2017-11-26', 'studyFirstSubmitQcDate': '2017-12-01', 'lastUpdatePostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '5 years', 'description': 'Calculated from the date of treatment start until death, whichever comes first.'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': '5 years', 'description': 'Calculated from the date of treatment start until the time of disease progression or death, whichever comes first.'}, {'measure': 'Tumor necrosis rate', 'timeFrame': '5 years', 'description': 'The percentage of tumor necrosis calculated in the resected specimen in Arm 2.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteosarcoma', 'pelvis', 'sacrum'], 'conditions': ['Osteosarcoma of Pelvis']}, 'descriptionModule': {'briefSummary': 'To study the effect of the timing of surgery on outcome of patients with nonmetastatic osteosarcoma of pelvis and sacrum.', 'detailedDescription': 'Successful therapeutic interventions to prevent disease progression in patients with nonmetastatic osteosarcoma of pelvis and sacrum have included surgery with adjuvant chemotherapy. Pre-surgical chemotherapy has been advocated for these patients because of putative improvement in event-free survival (EFS). The advantages of pre-surgical chemotherapy include early administration of systemic chemotherapy, shrinkage of primary tumor, and pathologic identification of risk groups. The theoretic disadvantage is that it exposes a large tumor burden to marginally effective chemotherapy, especially in the axial region. The contribution of chemotherapy and surgery timing has not been tested rigorously. To study the effect of the timing of surgery on outcome of patients with nonmetastatic osteosarcoma of pelvis and sacrum, we conducted multicenter randomized trial to determine whether chemotherapy administered before definitive resection of primary tumors improved EFS and overall survival compared with traditional resection of the primary tumor followed by adjuvant chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>10 years and \\<40 years;\n* High-grade nonmetastatic osteosarcoma in pelvis or sacrum;\n* Diagnosis confirmed histologically and reviewed centrally;\n* No evidence of metastatic disease with computed tomography scan of the chest and radionuclide bone scan, or Positron Emission Tomography (PET/CT) within 2 weeks of entry;\n* No prior therapy;\n* Eastern Cooperative Oncology Group performance status 0-1;\n* Life expectancy \\>3 months;\n* Adequate renal, hepatic, and hemopoietic function;\n\nExclusion Criteria:\n\n* Previously treated by chemotherapy or unplanned surgery in other hospital;\n* Have had other kinds of malignant tumors at the same time;\n* Uncontrolled complications, such as diabetes mellitus and so on;\n* Intravascular tumor thrombus on enhanced CT or magnetic resonance (MR);\n* Unresectable disease evaluated by surgeons.'}, 'identificationModule': {'nctId': 'NCT03360760', 'briefTitle': 'Timing of Surgery in Nonmetastatic Osteosarcoma of the Pelvis and Sacrum', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Presurgical Chemotherapy Compared With Immediate Surgery and Adjuvant Chemotherapy for Nonmetastatic Osteosarcoma of the Pelvis and Sacrum', 'orgStudyIdInfo': {'id': 'PKUPH-sarcoma 04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre surgical Chemotherapy', 'description': "Immediate pre surgical chemotherapy treated with four drugs including doxorubicin, cisplatin, high-dose methotrexate (MTX) and ifosfamide in eleven weeks, and then definitive surgery followed by adjuvant chemotherapy according to chemotherapy regimen in Peking University People's Hospital(PKUPH).", 'interventionNames': ['Drug: Doxorubicin', 'Drug: Cisplatin', 'Drug: Methotrexate', 'Drug: Ifosfamide', 'Procedure: definitive surgery', 'Other: pre surgical chemotherapy']}, {'type': 'OTHER', 'label': 'Immediate Surgery', 'description': 'Immediate definitive surgery, and then post operative chemotherapy based on doxorubicin, cisplatin, high-dose MTX and ifosfamide according to chemotherapy regimen in PKUPH.', 'interventionNames': ['Drug: Doxorubicin', 'Drug: Cisplatin', 'Drug: Methotrexate', 'Drug: Ifosfamide', 'Procedure: definitive surgery']}], 'interventions': [{'name': 'Doxorubicin', 'type': 'DRUG', 'otherNames': ['Adriamycin'], 'description': '60mg/m\\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH', 'armGroupLabels': ['Immediate Surgery', 'Pre surgical Chemotherapy']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['cisplatinum', 'platamin'], 'description': '100mg/m\\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH', 'armGroupLabels': ['Immediate Surgery', 'Pre surgical Chemotherapy']}, {'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['HD-MTX'], 'description': 'High dose of methotrexate (8-12g/m\\^2), in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH', 'armGroupLabels': ['Immediate Surgery', 'Pre surgical Chemotherapy']}, {'name': 'Ifosfamide', 'type': 'DRUG', 'otherNames': ['ifosphamide'], 'description': '12g/m\\^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH', 'armGroupLabels': ['Immediate Surgery', 'Pre surgical Chemotherapy']}, {'name': 'definitive surgery', 'type': 'PROCEDURE', 'description': 'Including limb-sparing procedure and amputation', 'armGroupLabels': ['Immediate Surgery', 'Pre surgical Chemotherapy']}, {'name': 'pre surgical chemotherapy', 'type': 'OTHER', 'otherNames': ['neoadjuvant chemotherapy'], 'description': 'chemotherapy that given before definitive surgery', 'armGroupLabels': ['Pre surgical Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Xu, M.D.', 'role': 'CONTACT', 'email': 'xujie_pkuph@sina.com', 'phone': '86 15901040835'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jie Xu, M.D.', 'role': 'CONTACT', 'email': 'xujie_pkuph@sina.com', 'phone': '86 15901040835'}, {'name': 'Xie Lu, M.D.', 'role': 'CONTACT', 'email': 'sweetdoctor@163.com', 'phone': '86 13401044719'}], 'overallOfficials': [{'name': 'Wei Guo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Musculoskeletal Tumor Center', 'investigatorFullName': 'GUO WEI', 'investigatorAffiliation': "Peking University People's Hospital"}}}}