Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Soft Tissue Sarcoma

Study Description

Brief Summary: 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. PURPOSE: Phase II trial to study the effectiveness of combining cisplatin and doxorubicin in treating patients who have soft tissue sarcoma.

Detailed Description: 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 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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