Combination Chemotherapy in Treating Patients With Soft Tissue Sarcoma
NCT ID: NCT00002492
Last Updated: 2016-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1991-11-30
2000-02-29
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combining cisplatin and doxorubicin in treating patients who have soft tissue sarcoma.
Detailed Description
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OUTLINE: 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.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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cisplatin
doxorubicin hydrochloride
isolated limb perfusion
conventional surgery
brachytherapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
PATIENT 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
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
18 Years
120 Years
ALL
No
Sponsors
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University of Miami
OTHER
Principal Investigators
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Pasquale W. Benedetto, MD
Role: STUDY_CHAIR
University of Miami Sylvester Comprehensive Cancer Center
Locations
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Sylvester Cancer Center, University of Miami
Miami, Florida, United States
Countries
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Other Identifiers
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SCCC-1989032
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-V92-0066
Identifier Type: -
Identifier Source: secondary_id
89253
Identifier Type: -
Identifier Source: org_study_id