Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-03-06 @ 9:56 AM
Study NCT ID:
NCT00662233
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2008-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients With Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D058405', 'term': 'Desmoplastic Small Round Cell Tumor'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D001918', 'term': 'Brachytherapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'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': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1991-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2013-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-04', 'studyFirstSubmitDate': '2008-04-18', 'studyFirstSubmitQcDate': '2008-04-18', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy in terms of long-term disease-free survival'}, {'measure': 'Clinical response of the tumors'}, {'measure': 'Pathologic response of the tumors'}, {'measure': 'Long term disease-free survival'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['alveolar childhood rhabdomyosarcoma', 'previously treated childhood rhabdomyosarcoma', 'previously untreated childhood rhabdomyosarcoma', 'recurrent childhood rhabdomyosarcoma', 'nonmetastatic childhood soft tissue sarcoma', 'recurrent childhood soft tissue sarcoma', 'childhood desmoplastic small round cell tumor', 'ovarian sarcoma', 'stage II uterine sarcoma', 'stage III uterine sarcoma', 'embryonal childhood rhabdomyosarcoma'], 'conditions': ['Ovarian Cancer', 'Sarcoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.\n\nPURPOSE: This clinical trial is studying how well combination chemotherapy works in treating patients with sarcoma.', 'detailedDescription': 'OBJECTIVES:\n\n* To evaluate the efficacy, in terms of clinical response, pathologic response, and long-term disease-free survival, of a multidrug chemotherapy regimen patients with spindle cell or small round cell sarcoma.\n\nOUTLINE: This is a multicenter study.\n\n* Induction therapy: Patients receive vincristine IV, cyclophosphamide IV over 1 hour and doxorubicin hydrochloride IV over 48 hours on day 1 in week 0. Patients continue to receive vincristine IV once weekly in weeks 1 and 2. Patients also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 3. Treatment repeats every 6 weeks for 2 courses.\n* Local control: After completing induction therapy, patients are reevaluated for local control therapy. Some patients may undergo surgery and/or radiotherapy (e.g., brachytherapy, intraoperative radiotherapy, external beam therapy). Patients who undergo surgery begin consolidation therapy 2 weeks after completing surgery. Some patients undergo radiotherapy 5 days a week for 5½ weeks beginning at week 12 and/or after surgery (weeks 15-16).\n* Consolidation therapy: Patients receive vincristine IV, doxorubicin hydrochloride IV over 1 hour, and cyclophosphamide IV over 1 hour once in weeks 12 and 18\\*. Patients also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 15. Patients are reevaluated for local control therapy at week 21.\n\nNOTE: \\*Patients undergoing radiotherapy do not receive doxorubicin hydrochloride in week 18 or week 24.\n\n* Maintenance therapy: Patient receive vincristine IV, doxorubicin hydrochloride IV over 1 hour, and cyclophosphamide IV over 1 hour once in week 24. Patients also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 21. Treatment repeats every 6 weeks for 3 courses. In week 36, patients receive vincristine, doxorubicin hydrochloride and cyclophosphamide OR etoposide and ifosfamide as before. In week 39 patients receive etoposide and ifosfamide as before.\n\nAfter completion of treatment, patients are followed periodically for at least 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of any of the following:\n\n * High-grade nonmetastatic, nonrhabdomyosarcomatous soft tissue sarcomas (excluding undifferentiated sarcoma and Ewing sarcoma)\n * Small round cell sarcomas (excluding primitive neuroectodermal tumors of soft tissue) (closed to accrual)\n * Undifferentiated sarcomas (closed to accrual)\n * Rhabdomyosarcomas (excluding non-parameningeal head tumors, vaginal or stage I paratesticular) (closed to accrual)\n * All alveolar rhabdomyosarcomas (closed to accrual)\n* No evidence distant metastatic disease (i.e., lung, bone, bone marrow)\n\n * Local or regional nodal disease allowed\n* No spindle cell tumors of bone\n* Primary lesions do not have to be resectable\n\nPATIENT CHARACTERISTICS:\n\n* Creatinine ≤1.5 mg/dL OR creatinine clearance \\> 60 mL/min/\n* AST/ALT \\< 2 times upper limit of normal (ULN)\n* Total bilirubin \\< 2 times ULN\n* LVEF ≥ 45%\n* No prior history of cancer\n* Not pregnant or nursing\n* Negative pregnancy test\n\nPRIOR CONCURRENT THERAPY:\n\n* Patients who have undergone radiation therapy after initial surgery are eligible but must have evaluation for metastatic disease within 2 weeks of starting chemotherapy\n* No prior chemotherapy'}, 'identificationModule': {'nctId': 'NCT00662233', 'briefTitle': 'Combination Chemotherapy in Treating Patients With Sarcoma', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Pilot Study for Soft Tissue Sarcoma', 'orgStudyIdInfo': {'id': 'CDR0000582271'}, 'secondaryIdInfos': [{'id': 'P30CA015083', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015083', 'type': 'NIH'}, {'id': '919110', 'type': 'OTHER', 'domain': 'Mayo Clinic Cancer Center'}, {'id': '542-91', 'type': 'OTHER', 'domain': 'Mayo Clinic IRB'}, {'id': '0791', 'type': 'REGISTRY', 'domain': 'COGUM'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cyclophosphamide', 'type': 'DRUG'}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG'}, {'name': 'etoposide', 'type': 'DRUG'}, {'name': 'ifosfamide', 'type': 'DRUG'}, {'name': 'vincristine sulfate', 'type': 'DRUG'}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE'}, {'name': 'neoadjuvant therapy', 'type': 'PROCEDURE'}, {'name': 'therapeutic conventional surgery', 'type': 'PROCEDURE'}, {'name': 'brachytherapy', 'type': 'RADIATION'}, {'name': 'intraoperative radiation therapy', 'type': 'RADIATION'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Carola A. S. Arndt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}