Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Soft Tissue Sarcoma

Phase 2

Completed

• Conditions: Sarcoma

• Registration Number: NCT00002791
• Lead Sponsor: Radiation Therapy Oncology Group

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1997-02
• Study First Submitted: 1999-11-01
• Primary Completion: 2002-05
• Study First Submitted QC: 2004-09-01
• Study First Posted: 2004-09-02
• Study Completion: 2013-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-23
• Last Update Posted: 2014-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (237)

Veterans Affairs Medical Center - Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Alabama Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Huntsville Hospital System; 🇺🇸 Huntsville, Alabama, United States

Urology Associates - Mobile AL; 🇺🇸 Mobile, Alabama, United States

MBCCOP - University of South Alabama; 🇺🇸 Mobile, Alabama, United States

Alabama Oncology, LLC; 🇺🇸 Montgomery, Alabama, United States

Radiation Oncology Associates of West Alabama; 🇺🇸 Tuscallosa, Alabama, United States

Providence Cancer Therapy Center; 🇺🇸 Anchorage, Alaska, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Providence Saint Joseph Medical Center - Burbank; 🇺🇸 Burbank, California, United States

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