Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-01 @ 9:49 PM
Study NCT ID:
NCT00002492
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients With Soft Tissue Sarcoma
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': 'D002945', 'term': 'Cisplatin'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D001918', 'term': 'Brachytherapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum 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': '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': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1991-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2000-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-14', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-04-21', 'lastUpdatePostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-02', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage I adult soft tissue sarcoma', 'stage II adult soft tissue sarcoma', 'stage III adult soft tissue sarcoma'], 'conditions': ['Sarcoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combining cisplatin and doxorubicin in treating patients who have soft tissue sarcoma.', 'detailedDescription': 'OBJECTIVES: I. Determine the response in patients with resectable soft tissue sarcoma of the extremity treated with neoadjuvant intra-arterial cisplatin and IV doxorubicin followed by limb-sparing procedure or amputation, adjuvant IV cisplatin and IV doxorubicin, and radiotherapy. II. Determine the chemotherapeutic response in tumor specimens of patients treated with this regimen.\n\nOUTLINE: Neoadjuvant chemotherapy: Patients undergo arterial cannulation followed by cisplatin intra-arterially over 4 hours on day 1 and doxorubicin IV (beginning 15 minutes after completion of cisplatin infusion) on days 1-3. Treatment continues every 3 weeks for 2 courses in the absence of unacceptable toxicity. Patients undergo amputation or limb-sparing wide excision, as feasible, approximately 4 weeks after the second course. If surgery cannot be scheduled at this time for logistical reasons, a third course may be administered. Patients with an estimated tumor kill of at least 50% receive adjuvant chemotherapy as outlined below. Patients undergoing limb-sparing wide excision receive post-operative radiotherapy as outlined below. Adjuvant chemotherapy: Beginning 3-4 weeks after surgery, patients receive cisplatin IV over 4 hours on day 1 and doxorubicin as above on days 1-3. Treatment continues every 3 weeks for 4 courses in the absence of disease progression, stable disease, or unacceptable toxicity. Patients undergoing radiotherapy receive the final 3 courses of chemotherapy after completion of radiotherapy. Post-operative radiotherapy: Beginning after the first postoperative chemotherapy course and within 8 weeks after surgery, patients receive radiotherapy 5 days a week for 7-8 weeks. An interstitial implant using iridium Ir 192 may be used to administer the final doses of radiotherapy.\n\nPROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Diagnosis of intermediate- or high-grade soft tissue sarcoma of the extremity amenable to limb-sparing procedure or amputation Buttocks or shoulder lesions allowed if an artery is available for cannulation No metastasis\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Ejection fraction at least 50% by MUGA scan No history of congestive heart failure or severe angina pectoris Other: No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix Not pregnant Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00002492', 'briefTitle': 'Combination Chemotherapy in Treating Patients With Soft Tissue Sarcoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'CLINICAL AND PHARMACOLOGICAL STUDY OF CHEMOTHERAPY IN SOFT TISSUE SARCOMA', 'orgStudyIdInfo': {'id': '89253'}, 'secondaryIdInfos': [{'id': 'SCCC-1989032', 'type': 'OTHER', 'domain': 'University of Miami Sylvester Comprehensive Cancer Center'}, {'id': 'NCI-V92-0066'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG'}, {'name': 'isolated limb perfusion', 'type': 'DRUG'}, {'name': 'conventional surgery', 'type': 'PROCEDURE'}, {'name': 'brachytherapy', 'type': 'RADIATION'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Sylvester Cancer Center, University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Pasquale W. Benedetto, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Miami Sylvester Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}}}}