Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Primary or Recurrent Sarcoma

Phase 2

Withdrawn

• Conditions: Stage III Adult Soft Tissue Sarcoma; Recurrent Adult Soft Tissue Sarcoma; Stage IVA Adult Soft Tissue Sarcoma; Stage IIB Adult Soft Tissue Sarcoma; Stage IIC Adult Soft Tissue Sarcoma

• Registration Number: NCT00017160
• 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 chemotherapy, radiation therapy, and surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation therapy, and surgery in treating patients who have primary or recurrent sarcoma.

Detailed Description

OBJECTIVES:

* Determine the overall survival of patients with primary or recurrent retroperitoneal sarcomas treated with neoadjuvant doxorubicin and ifosfamide, radiotherapy, and surgical resection.

* Assess local-regional control in patients treated with this regimen.

* Determine the disease-free survival of patients treated with this regimen.

* Determine the pathologic response in patients treated with this regimen.

* Determine the toxic effects of this regimen in these patients.

* Determine the complications in patients treated with this regimen.

OUTLINE: Patients receive doxorubicin IV continuously on days 1-3 and ifosfamide IV over 3 hours on days 1-4. Patients also receive filgrastim (G-CSF) beginning on day 5 and continuing until blood counts recover. Treatment repeats every 21 days for a maximum of 4 courses in the absence of unacceptable toxicity. Beginning 2-4 weeks after chemotherapy, patients undergo radiotherapy daily, 5 days a week, for 5-6 weeks. Beginning 4-7 weeks after radiotherapy, patients undergo complete surgical resection with intraoperative or postoperative radiotherapy or brachytherapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 24 months.

Study Timeline

• Study First Submitted: 2001-06-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-27

Recruitment & Eligibility

• Status: WITHDRAWN
• 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 (235)

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

Comprehensive Cancer Institute of Huntsville; 🇺🇸 Huntsville, Alabama, United States

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

MBCCOP - Gulf Coast; 🇺🇸 Mobile, Alabama, United States

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

DCH Cancer Treatment Center; 🇺🇸 Tuscaloosa, Alabama, United States

Foundation for Cancer Research and Education; 🇺🇸 Phoenix, Arizona, United States

Mount Diablo Medical Center; 🇺🇸 Concord, California, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

Saint Agnes Cancer Center; 🇺🇸 Fresno, California, United States

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