Combination Chemotherapy in Treating Patients With Soft Tissue Sarcoma
Launched by UNIVERSITY OF MIAMI · Apr 21, 2004
Trial Information
Current as of May 18, 2025
Completed
Keywords
ClinConnect Summary
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.
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 infusio...
Gender
ALL
Eligibility criteria
- • 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
- • 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
About University Of Miami
The University of Miami, a leading academic institution, is dedicated to advancing medical research and improving patient care through innovative clinical trials. With a commitment to excellence in education and research, the university fosters collaboration among multidisciplinary teams to explore new therapies and treatment modalities. Its extensive clinical programs are supported by state-of-the-art facilities and a diverse patient population, enabling the exploration of cutting-edge solutions to complex health challenges. The University of Miami is poised to contribute significantly to the field of medicine through its rigorous scientific inquiry and a steadfast commitment to ethical research practices.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Miami, Florida, United States
Patients applied
Trial Officials
Pasquale W. Benedetto, MD
Study Chair
University of Miami Sylvester Comprehensive Cancer Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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