Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-25 @ 3:05 PM
Study NCT ID:
NCT00204568
Status:
UNKNOWN
Last Update Posted:
2013-01-08
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trofosfamide Versus Adriamycin in Elderly Patients With Soft Tissue Sarcoma (STS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'C003726', 'term': 'trofosfamide'}], '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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 117}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-07', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2013-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival after 6 months', 'timeFrame': 'after 6 months', 'description': 'Progression-free survival after 6 months'}], 'secondaryOutcomes': [{'measure': 'Grade III/IV toxicity Objective remission rate according to RECIST criteria Overall survival • Quality of life according to EORTC QLQ-30', 'description': 'Grade III/IV toxicity Objective remission rate according to RECIST criteria Overall survival Quality of life according to EORTC QLQ-30'}]}, 'conditionsModule': {'conditions': ['Sarcoma, Soft Tissue']}, 'descriptionModule': {'briefSummary': 'The goal of this trial is to determine whether oral continuous (metronomic) therapy with trofosfamide results in a similar rate of progression-free time after 6 months as intravenous treatment with adriamycin. In addition, the study is intended to investigate the level of toxicity associated with the two treatment regimens (safety profile).', 'detailedDescription': 'Group A:Adriamycin (60 mg/m2, d1, qd22) 75 mg/m2 may be applied instead of 60 mg/m2 for patients between 60 and 70 years of age (optional) Group B:Trofosfamide (300 mg absolute p.o. qd over 7 days, then 150 mg p.o. absolute qd continuously) In case of absence of any toxicity during treatment with trofosfamide 150 mg absolute a dose escalation to 200 mg absolute is allowed (optional)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically established metastatic (N+ or M1 = stage IV) or non-resectable soft tissue sarcoma·\n* Grading II/III (Guillou et al. J Clin Oncol 1997)\n* At least 1 measurable tumor parameter according to RECIST criteria\n* Evidence of progression or primary manifestation (except osseous metastases and pleural effusion)\n* No previous radiation therapy of the only measurable lesion\n* No previous chemotherapy for metastatic disease; previous adjuvant chemotherapy is permitted if there was no progression of the disease within a period of 6 months\n* Patients aged 60 years and beyond\n* Written patient informed consent\n* ECOG Status 0-2\n* Granulocytes \\>= 2 x 10\\*\\*9/l and thrombocytes \\>= 100 x 10\\*\\*/l\n* Serum creatinine, bilirubin \\< 1.5 times the upper limit of normal value, albumin \\> 25 g/l\n* No severe comorbidity including psychosis or any previous history of uncontrolled cardiovascular disease\n* Normal left-ventricular function by echocardiography or MUGA scan\n* No symptomatic CNS metastases\n* Willingness to receive regular follow-up examinations\n\nExclusion Criteria:\n\n* Histological grading of malignancy: G I\n* Histology of gastrointestinal stromal tumor, chondrosarcoma, uterine stromal sarcoma, mesothelioma, neuroblastoma, osteosarcoma, Ewing´s sarcoma/PNET, desmoplastic round cell tumor, embryonal rhabdomyosarcoma, alveolar soft tissue sarcoma\n* Less than 5 years free of secondary malignancy except adequately treated carcinoma in situ (CIS) of the cervix, the bladder urothelium, basal cell carcinoma, or adenoma of the colon including pTIS, pTIN'}, 'identificationModule': {'nctId': 'NCT00204568', 'briefTitle': 'Trofosfamide Versus Adriamycin in Elderly Patients With Soft Tissue Sarcoma (STS)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Schleswig-Holstein'}, 'officialTitle': 'Randomized Phase II Trial of Trofosfamide vs. Adriamycin in Elderly Patients With Previously Untreated Metastatic Soft Tissue Sarcoma', 'orgStudyIdInfo': {'id': 'jth_001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Adriamycin mono', 'interventionNames': ['Drug: Adriamycin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Trofosfamide', 'interventionNames': ['Drug: Trofosfamide']}], 'interventions': [{'name': 'Adriamycin', 'type': 'DRUG', 'description': '60 mg/m2, d1, W d22', 'armGroupLabels': ['1']}, {'name': 'Trofosfamide', 'type': 'DRUG', 'description': '300 mg absolute d1-7, followed by 150 mg absolute continuously', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'overallOfficials': [{'name': 'Joerg T. Hartmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, 'collaborators': [{'name': 'Arbeitsgemeinschaft fur Internistische Onkologie', 'class': 'OTHER'}, {'name': 'German Sarcoma Group', 'class': 'OTHER'}, {'name': 'French Sarcoma Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. J. T. Hartmann', 'investigatorFullName': 'J. T. Hartmann', 'investigatorAffiliation': 'University Hospital Schleswig-Holstein'}}}}