Search / Trial NCT00002492

Combination Chemotherapy in Treating Patients With Soft Tissue Sarcoma

Launched by UNIVERSITY OF MIAMI · Apr 21, 2004

Trial Information

Current as of December 07, 2024

Completed

Keywords

Stage I Adult Soft Tissue Sarcoma Stage Ii Adult Soft Tissue Sarcoma Stage Iii Adult Soft Tissue Sarcoma

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

Trial Officials

Pasquale W. Benedetto, MD

Study Chair

University of Miami Sylvester Comprehensive Cancer Center

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.

Locations

Miami, Florida, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

Similar Trials