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

Recurrent Adult Soft Tissue Sarcoma Clinical Trial

Official title: Phase II Study of Neoadjuvant Doxorubicin and Ifosfamide, Radiotherapy, and Surgical Resection in Patients With Primary or Recurrent Retroperitoneal Sarcoma

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Recurrent Adult Soft Tissue Sarcoma
• Sarcoma
• Stage IIB Adult Soft Tissue Sarcoma
• Stage IIC Adult Soft Tissue Sarcoma
• Stage III Adult Soft Tissue Sarcoma
• Stage IVA Adult Soft Tissue Sarcoma

• NCT number: NCT00017160
• Study type: Interventional
• Source: Radiation Therapy Oncology Group
• Status: Withdrawn
• Phase: Phase 2