Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-03-01 @ 12:20 AM
Study NCT ID:
NCT02986503
Status:
COMPLETED
Last Update Posted:
2016-12-08
First Post:
2016-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
European Study in Bone Sarcoma Patients Over 40 Years
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'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-05', 'studyFirstSubmitDate': '2016-11-25', 'studyFirstSubmitQcDate': '2016-12-05', 'lastUpdatePostDateStruct': {'date': '2016-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free survival', 'timeFrame': 'from the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 168 months.', 'description': 'Survival without any events related to disease (e.g: progression, relapse or osteosarcoma related death)'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'from the date of randomization until the date of first documented progression of disease, whichever came first, assessed every 6 months, up to 168 months', 'description': 'Survival without progression of disease'}, {'measure': 'Disease-free survival', 'timeFrame': 'from the date of randomization until the date of first documented progression of disease, whichever came first, assessed every 6 months, up to 168 months', 'description': 'Survival without disease'}, {'measure': 'Metastasis-free survival', 'timeFrame': 'from the date of randomization until the date of first documented progression in term of metastasis, whichever came first, assessed every 3 months, up to 168 months', 'description': 'Survival without metastasis'}, {'measure': 'Overall survival', 'timeFrame': 'from the date of randomization until the end of the study, assessed every 3 months, up to 168 month', 'description': 'Global patients survival evaluation after treatment'}, {'measure': 'Chemotherapy toxicity', 'timeFrame': 'Every 3 weeks', 'description': 'Number and grade of adverse events related to the study treatments'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spindle Cell Sarcoma of Bone', 'Osteosarcoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ssg-org.net/wp-content/uploads/2011/05/Euroboss1.pdf', 'label': 'Euroboss I - A European treatment protocol for bone sarcoma in patients older than 40 years'}]}, 'descriptionModule': {'briefSummary': 'The study is a first step of a process to establish the standard chemotherapy treatment with the aim to improve outcome for patients with these rare tumours. For this reason the study will be non-controlled clinical trial.\n\nIn this regard, the study aims to determine the feasibility of intensive chemotherapy in this age group, and/or separate efficacy analyses according to the different histologic categories and whether the number of patients recruited by the co-operating groups permits future randomised studies.', 'detailedDescription': 'Wide surgical removal of the tumor with the addition of a systemic treatment based on the antineoplastic drugs active against osteosarcoma (Adriamycin, Cisplatin, Ifosfamide, Methotrexate). The use of radiation therapy will be given to patients with unresectable tumors. It is recommended in patients who underwent inadequate surgical removal of the tumor. The addition of radiation therapy can not compensate for an adequate surgical treatment.\n\nAll the patients eligible for the study will receive the planned systemic treatment. Depending on clinical features, and feasibility of adequate surgical removal of the tumor, patients may receive primary chemotherapy followed by a postoperative chemotherapy treatment or only an adjuvant chemotherapy. In case of immediate surgery, patients will receive an adjuvant treatment with the 3-drug regimen (Cisplatin-Adriamycin-Ifosfamide).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '41 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients older than 40 years with highly malignant spindle cell sarcoma of bone', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologically proven diagnosis of high-grade sarcoma of bone of any site.\n2. Histologic types: osteosarcoma (high-grade surface, central primary and secondary), fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, dedifferentiated chondrosarcoma, angiosarcoma.\n3. Age: 41 - 65\n4. Normal bone marrow, hepatic, cardiac and renal function\n5. Absence of contraindications to the use of cisplatin, adriamycin, and ifosfamide\n6. Written informed consent\n\nExclusion Criteria:\n\n1. Planned chemotherapy and/or follow-up not feasible\n2. Previous chemotherapy treatment, which contraindicates the use of one or more drugs, included in the present protocol\n3. Previous chemotherapy treatment for the current tumor\n4. White blood count \\< 3.0 x 109/L, and platelets \\< 100 x 109/L\n5. Creatinine clearance \\< 70 ml/min\n6. Left ventricular ejection fraction \\< 55% or fractional shortening rate of the left ventricle \\<28%\n7. Serum transaminases and bilirubin \\> 2 times the normal values\n8. ECOG performance status \\> 2\n9. Chondrosarcoma or small/round cell bone sarcoma including mesenchymal chondrosarcoma and Ewing's family tumors."}, 'identificationModule': {'nctId': 'NCT02986503', 'acronym': 'EUROBOSS', 'briefTitle': 'European Study in Bone Sarcoma Patients Over 40 Years', 'organization': {'class': 'NETWORK', 'fullName': 'Italian Sarcoma Group'}, 'officialTitle': 'A European Treatment Protocol for Bone-sarcoma in Patients Older Than 40 Years', 'orgStudyIdInfo': {'id': 'EURO-B.O.S.S'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chemotherapy for Good responder', 'description': 'Doxorubicin + cisplatin + ifosfamide Pre-operative and post-operative chemotherapy for patients with good responder high grade osteosarcoma', 'interventionNames': ['Drug: Doxorubicin+cisplatin+ifosfamide']}, {'label': 'Chemotherapy for Poor responder', 'description': 'Doxorubicin+cisplatin+ifosfamide+methotrexate Pre-operative and post-operative chemotherapy for patients with poor responder high grade osteosarcoma', 'interventionNames': ['Drug: Doxorubicin+cisplatin+ifosfamide+methotrexate']}], 'interventions': [{'name': 'Doxorubicin+cisplatin+ifosfamide', 'type': 'DRUG', 'otherNames': ['Doxorubicin,cisplatin,ifosfamide'], 'description': 'Chemotherapy for Good responder high grade osteosarcoma', 'armGroupLabels': ['Chemotherapy for Good responder']}, {'name': 'Doxorubicin+cisplatin+ifosfamide+methotrexate', 'type': 'DRUG', 'otherNames': ['Doxorubicin,cisplatin,ifosfamide,methotrexate'], 'description': 'Chemotherapy for Poor responder high grade osteosarcoma', 'armGroupLabels': ['Chemotherapy for Poor responder']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-70176', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Cooperative Osteosarcoma Study Group', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '40136', 'city': 'Bologna', 'state': 'Bologna', 'country': 'Italy', 'facility': 'Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': 'SE-221 85', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Scandinavian Sarcoma Group', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Stefano Ferrari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Italian Sarcoma Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Anonymized results will be available upon request at the end of the study and public available into the repository systems like Clinicaltrial.gov'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Italian Sarcoma Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Scandinavian Sarcoma Group', 'class': 'OTHER'}, {'name': 'Cooperative Osteosarcoma Study Group', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}