Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Soft Tissue Sarcoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed by surgery in treating patients who have soft tissue sarcoma.
|Sarcoma||Biological: filgrastim Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: ifosfamide Drug: mesna Procedure: conventional surgery Radiation: brachytherapy Radiation: intraoperative radiation therapy Radiation: radioisotope therapy||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A PHASE II STUDY OF NEOADJUVANT CHEMOTHERAPY AND RADIATION THERAPY IN THE MANAGEMENT OF HIGH-RISK, HIGH-GRADE, SOFT TISSUE SARCOMAS OF THE EXTREMITIES AND BODY WALL|
|Study Start Date:||February 1997|
|Study Completion Date:||November 2013|
|Primary Completion Date:||May 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Assess whether patients with high-grade soft tissue sarcoma (STS) treated with neoadjuvant mesna/doxorubicin/ifosfamide/dacarbazine (MAID) plus radiotherapy in a cooperative group setting exhibit a response rate, toxicity, and complication rate comparable to those seen in pilot data collected by the Massachusetts General Hospital. II. Assess local control and local complications related to surgery and neoadjuvant MAID plus radiotherapy in these patients. III. Develop a tissue repository of frozen STS for ancillary genetic and flow cytometric analysis of these tumors. IV. Form an Intergroup Working Sarcoma Group that will develop a patient base, relationships, and support for the future development and completion of a phase III study of adjuvant therapy for STS.
OUTLINE: The following acronyms are used: DOX Doxorubicin, NSC-123127 DTIC Dacarbazine, NSC-45388 EBRT External-Beam Radiotherapy (equipment unspecified) G-CSF Filgrastim; Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629 IFF Ifosfamide, NSC-109724 MAID Mesna/DOX/IFF/DTIC Mesna Mercaptoethane sulfonate, NSC-113891 3-Drug Combination Chemotherapy plus Radiotherapy followed by Surgery followed, if indicated, by Radiotherapy followed by 3-Drug Combination Chemotherapy. MAID; plus EBRT to the primary tumor and suspected microscopic disease; followed by minimal wide surgical excision; followed, if positive margins, by postoperative EBRT; followed by MAID.
PROJECTED ACCRUAL: There will be 60 patients accrued into this study within 15 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002791
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|Study Chair:||William G. Kraybill, MD, FACS||Roswell Park Cancer Institute|
|Study Chair:||Ronald H. Blum, MD||New York University School of Medicine|