NCT00017160

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	doxorubicin
DRUG	filgrastim
DRUG	ifosfamide
PROCEDURE	biological response modifier therapy
PROCEDURE	brachytherapy
PROCEDURE	chemotherapy
PROCEDURE	colony-stimulating factor therapy
PROCEDURE	conventional surgery
PROCEDURE	cytokine therapy
PROCEDURE	intraoperative radiotherapy
PROCEDURE	radiation therapy
PROCEDURE	surgery

Timeline

• First posted: 2003-01-27
• Last updated: 2013-06-27

Locations

235 sites across 2 countries: United States, Canada